Reliability and Validity of Dual-Task Mobility Assessments in People with Chronic Stroke

Background

The ability to perform a cognitive task while walking simultaneously (dual-tasking) is important in real life. However, the psychometric properties of dual-task walking tests have not been well established in stroke.

Objective

To assess the test-retest reliability, concurrent and known-groups validity of various dual-task walking tests in people with chronic stroke.

Design

Observational measurement study with a test-retest design.

Methods

Eighty-eight individuals with chronic stroke participated. The testing protocol involved four walking tasks (walking forward at self-selected and maximal speed, walking backward at self-selected speed, and crossing over obstacles) performed simultaneously with each of the three attention-demanding tasks (verbal fluency, serial 3 subtractions or carrying a cup of water). For each dual-task condition, the time taken to complete the walking task, the correct response rate (CRR) of the cognitive task, and the dual-task effect (DTE) for the walking time and CRR were calculated. Forty-six of the participants were tested twice within 3–4 days to establish test-retest reliability.

Results

The walking time in various dual-task assessments demonstrated good to excellent reliability [Intraclass correlation coefficient (ICC_2,1) = 0.70–0.93; relative minimal detectable change at 95% confidence level (MDC₉₅%) = 29%-45%]. The reliability of the CRR (ICC_2,1 = 0.58–0.81) and the DTE in walking time (ICC_2,1 = 0.11–0.80) was more varied. The reliability of the DTE in CRR (ICC_2,1 = -0.31–0.40) was poor to fair. The walking time and CRR obtained in various dual-task walking tests were moderately to strongly correlated with those of the dual-task Timed-up-and-Go test, thus demonstrating good concurrent validity. None of the tests could discriminate fallers (those who had sustained at least one fall in the past year) from non-fallers.

Limitation

The results are generalizable to community-dwelling individuals with chronic stroke only.

Conclusions

The walking time derived from the various dual-task assessments generally demonstrated good to excellent reliability, making them potentially useful in clinical practice and future research endeavors. However, the usefulness of these measurements in predicting falls needs to be further explored. Relatively low reliability was shown in the cognitive outcomes and DTE, which may not be preferred measurements for assessing dual-task performance.     

Cardiorespiratory Fitness,Sedentary Behaviour and Physical Activity Are Independently Associated with the Metabolic Syndrome,Results from the SCAPIS Pilot Study

Background

Previous studies on the relation between lifestyle and the metabolic syndrome lack one or several aspects of the physical activity pattern in the analyses or cardiorespiratory fitness. Likewise, both uni- and triaxial accelerometry have been used, though, the predictive validity of these two modes has not been compared.

Objectives

The aims of the present study were firstly to investigate the independent relation between cardiorespiratory fitness and physical activity pattern to the metabolic syndrome (MetS) and secondly to examine the predictive validity of uni- and triaxial accelerometry, respectively.

Methods

Data was extracted from the SCAPIS pilot study (n=930, mean age 57.7 yrs). Physical activity pattern was assessed by accelerometry. Cardiorespiratory fitness was estimated using cycle ergometry. MetS was defined per the Adult Treatment Panel III from the National Cholesterol Education Program definition.

Results

Time spent sedentary (OR: 2.38, 95% CI: 1.54-4.24 for T3 vs T1), in light intensity (OR: 0.50, 95% CI: 0.28-0.90) and in moderate-to-vigorous activity (OR: 0.33, 95% CI: 0.18-0.61), as well as cardiorespiratory fitness (OR: 0.24, 95% CI:0.12-0.48), were all independently related to the prevalence of MetS after adjustment for potential confounders, fitness and/or the other aspects of the physical activity pattern. In addition, we found that triaxial analyses were more discriminant, with ORs farther away from the reference group and additional significant ORs.

Conclusion

The finding that several aspects of the physical activity pattern reveal independent relations to the MetS makes new possible targets for behaviour change of interest, focusing on both exercise and everyday life. When assessing the risk status of a patient, it is advised that triaxial accelerometry is used.     

Are the 10 Meter and 6 Minute Walk Tests Redundant in Patients with Spinal Cord Injury?

Objective

To evaluate the relationship and redundancy between gait speeds measured by the 10 Meter Walk Test (10MWT) and 6 Minute Walk Test (6MWT) after motor incomplete spinal cord injury (iSCI). To identify gait speed thresholds supporting functional ambulation as measured with the Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI).

Design

Prospective observational cohort.

Setting

Seven outpatient rehabilitation centers from the Christopher and Dana Reeve Foundation NeuroRecovery Network (NRN).

Participants

249 NRN patients with American Spinal Injury Association Impairment Scale (AIS) level C (n = 20), D (n = 179) and (n = 50) iSCI not AIS evaluated, from February 2008 through April 2011.

Interventions

Locomotor training using body weight support and walking on a treadmill, overground and home/community practice.

Main Outcome Measure(s)

10MWT and 6MWT collected at enrollment, approximately every 20 sessions, and upon discharge.

Results

The 10MWT and 6MWT speeds were highly correlated and the 10MWT speeds were generally faster. However, the predicted 6MWT gait speed from the 10MWT, revealed increasing error with increased gait speed. Regression lines remained significantly different from lines of agreement, when the group was divided into fast (≥0.44 m/s) and slow walkers (<0.44 m/s). Significant differences between 6MWT and 10MWT gait speeds were observed across SCI-FAI walking mobility categories (Wilcoxon sign rank test p<.001), and mean speed thresholds for limited community ambulation differed for each measure. The smallest real difference for the 6MWT and 10MWT, as well as the minimally clinically important difference (MCID) values, were also distinct for the two tests.

Conclusions

While the speeds were correlated between the 6MWT and 10MWT, redundancy in the tests using predictive modeling was not observed. Different speed thresholds and separate MCIDs were defined for community ambulation for each test.     

Correlation between Body Composition and Walking Capacity in Severe Obesity

Background

Obesity is associated with mobility reduction due to mechanical factors and excessive body fat. The six-minute walk test (6MWT) has been used to assess functional capacity in severe obesity.

Objective

To determine the association of BMI, total and segmental body composition with distance walked (6MWD) during the six-minute walk test (6MWT) according to gender and obesity grade.

Setting

University of São Paulo Medical School, Brazil; Public Practice.

Methods

Functional capacity was assessed by 6MWD and body composition (%) by bioelectrical impedance analysis in 90 patients.

Results

The mean 6MWD was 514.9 ± 50.3 m for both genders. The male group (M: 545.2 ± 46.9 m) showed a 6MWD higher (p = 0.002) than the female group (F: 505.6 ± 47.9 m). The morbid obese group (MO: 524.7 ± 44.0 m) also showed a 6MWD higher (p = 0.014) than the super obese group (SO: 494.2 ± 57.0 m). There was a positive relationship between 6MWD and fat free mass (FFM), FFM of upper limps (FFM_UL), trunk (FFM_TR) and lower limbs (FFM_LL). Female group presented a positive relationship between 6MWD and FFM, FFM_UL and FFM_LL and male group presented a positive relationship between 6MWD and FFM_TR. In morbid obese group there was a positive relationship between 6MWD with FFM, FFM_UL, FFM_TR and FFM_LL. The super obese group presented a positive relationship between 6MWD with FFM, FFM_TR and FFM_LL.

Conclusions

Total and segmental FFM is associated with a better walking capacity than BMI.     

Negative Perceptions of Aging and Decline in Walking Speed: A Self-Fulfilling Prophecy

Introduction

Walking speed is a meaningful marker of physical function in the aging population. While it is a primarily physical measure, experimental studies have shown that merely priming older adults with negative stereotypes about aging results in immediate declines in objective walking speed. What is not clear is whether this is a temporary experimental effect or whether negative aging stereotypes have detrimental effects on long term objective health. We sought to explore the association between baseline negative perceptions of aging in the general population and objective walking speed 2 years later.

Method

4,803 participations were assessed over 2 waves of The Irish Longitudinal Study on Ageing (TILDA), a prospective, population representative study of adults aged 50+ in the Republic of Ireland. Wave 1 measures – which included the Aging Perceptions Questionnaire, walking speed and all covariates - were taken between 2009 and 2011. Wave 2 measures – which included a second measurement of walking speed and covariates - were collected 2 years later between March and December 2012. Walking speed was measured as the number of seconds to complete the Timed Up-And-Go (TUG) task. Participations with a history of stroke, Parkinson’s disease or an MMSE < 18 were excluded.

Results

After full adjustment for all covariates (age, gender, level of education, disability, chronic conditions, medications, global cognition and baseline TUG) negative perceptions of aging at baseline were associated with slower TUG speed 2 years later (B=.03, 95% CI = .01 to 05, p< .05).

Conclusions

Walking speed has previously been considered to be a consequence of physical decline but these results highlight the direct role of psychological state in predicting an objective aging outcome. Negative perceptions about aging are a potentially modifiable risk factor of some elements of physical decline in aging.     

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre,Single-Blind Randomised Control Pilot Trial

Objectives

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke.

Design

This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services

Participants

Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments

Intervention

Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks.Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up.

Results

Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms.

Conclusions

Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention.

Trial Registration

Clinicaltrials.gov NCT01600391     

Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective,Pre-Post Intervention,Proof-of-Concept Study

Background

The compact Motorized orthosis for home rehabilitation of Gait (MoreGait) was developed for continuation of locomotion training at home. MoreGait generates afferent stimuli of walking with the user in a semi-supine position and provides feedback about deviations from the reference walking pattern.

Objective

Prospective, pre-post intervention, proof-of-concept study to test the feasibility of an unsupervised home-based application of five MoreGait prototypes in subjects with incomplete spinal cord injury (iSCI).

Methods

Twenty-five (5 tetraplegia, 20 paraplegia) participants with chronic (mean time since injury: 5.8 ± 5.4 (standard deviation, SD) years) sensorimotor iSCI (7 ASIA Impairment Scale (AIS) C, 18 AIS D; Walking Index for Spinal Cord Injury (WISCI II): Interquartile range 9 to 16) completed the training (45 minutes / day, at least 4 days / week, 8 weeks). Baseline status was documented 4 and 2 weeks before and at training onset. Training effects were assessed after 4 and 8 weeks of therapy.

Results

After therapy, 9 of 25 study participants improved with respect to the dependency on walking aids assessed by the WISCI II. For all individuals, the short-distance walking velocity measured by the 10-Meter Walk Test showed significant improvements compared to baseline (100%) for both self-selected (Mean 139.4% ± 35.5% (SD)) and maximum (Mean 143.1% ± 40.6% (SD)) speed conditions as well as the endurance estimated with the six-minute walk test (Mean 166.6% ± 72.1% (SD)). One device-related adverse event (pressure sore on the big toe) occurred in over 800 training sessions.

Conclusions

Home-based robotic locomotion training with MoreGait is feasible and safe. The magnitude of functional improvements achieved by MoreGait in individuals with iSCI is well within the range of complex locomotion robots used in hospitals. Thus, unsupervised MoreGait training potentially represents an option to prolong effective training aiming at recovery of locomotor function beyond in-patient rehabilitation.

Trial Registration

German Clinical Trials Register (DKRS) DRKS00005587     

Body Acceleration as Indicator for Walking Economy in an Ageing Population

Background

In adults, walking economy declines with increasing age and negatively influences walking speed. This study aims at detecting determinants of walking economy from body acceleration during walking in an ageing population.

Methods

35 healthy elderly (18 males, age 51 to 83 y, BMI 25.5±2.4 kg/m2) walked on a treadmill. Energy expenditure was measured with indirect calorimetry while body acceleration was sampled at 60Hz with a tri-axial accelerometer (GT3X+, ActiGraph), positioned on the lower back. Walking economy was measured as lowest energy needed to displace one kilogram of body mass for one meter while walking (WCost_min, J/m/kg). Gait features were extracted from the acceleration signal and included in a model to predict WCost_min.

Results

On average WCost_min was 2.43±0.42 J/m/kg and correlated significantly with gait rate (r² = 0.21, p<0.01) and regularity along the frontal (anteroposterior) and lateral (mediolateral) axes (r² = 0.16, p<0.05 and r² = 0.12, p<0.05 respectively). Together, the three variables explained 46% of the inter-subject variance (p<0.001) with a standard error of estimate of 0.30 J/m/kg. WCost_min and regularity along the frontal and lateral axes were related to age (WCost_min: r² = 0.44, p<0.001; regularity: r² = 0.16, p<0.05 and r² = 0.12, p<0.05 respectively frontal and lateral).

Conclusions

The age associated decline in walking economy is induced by the adoption of an increased gait rate and by irregular body acceleration in the horizontal plane.     

Timed Rise from Floor as a Predictor of Disease Progression in Duchenne Muscular Dystrophy: An Observational Study

Background

The role of timed items, and more specifically, of the time to rise from the floor, has been reported as an early prognostic factor for disease progression and loss of ambulation. The aim of our study was to investigate the possible effect of the time to rise from the floor test on the changes observed on the 6MWT over 12 months in a cohort of ambulant Duchenne boys.

Subjects and methods

A total of 487 12-month data points were collected from 215 ambulant Duchenne boys. The age ranged between 5.0 and 20.0 years (mean 8.48 ±2.48 DS).

Results

The results of the time to rise from the floor at baseline ranged from 1.2 to 29.4 seconds in the boys who could perform the test. 49 patients were unable to perform the test at baseline and 87 at 12 month The 6MWT values ranged from 82 to 567 meters at baseline. 3 patients lost the ability to perform the 6mwt at 12 months. The correlation between time to rise from the floor and 6MWT at baseline was high (r = 0.6, p<0.01).

Conclusions

Both time to rise from the floor and baseline 6MWT were relevant for predicting 6MWT changes in the group above the age of 7 years, with no interaction between the two measures, as the impact of time to rise from the floor on 6MWT change was similar in the patients below and above 350 m. Our results suggest that, time to rise from the floor can be considered an additional important prognostic factor of 12 month changes on the 6MWT and, more generally, of disease progression.     

Accelerometer Cut Points for Physical Activity Assessment of Older Adults with Parkinson’s Disease

Objective

To define accelerometer cut points for different walking speeds in older adults with mild to moderate Parkinson’s disease.

Method

A volunteer sample of 30 older adults (mean age 73; SD 5.4 years) with mild to moderate Parkinson’s disease walked at self-defined brisk, normal, and slow speeds for three minutes in a circular indoor hallway, each wearing an accelerometer around the waist. Walking speed was calculated and used as a reference measure. Through ROC analysis, accelerometer cut points for different levels of walking speed in counts per 15 seconds were generated, and a leave-one-out cross-validation was performed followed by a quadratic weighted Cohen’s Kappa, to test the level of agreement between true and cut point–predicted walking speeds.

Results

Optimal cut points for walking speeds ≤ 1.0 m/s were ≤ 328 and ≤ 470 counts/15 sec; for speeds > 1.3 m/s, they were ≥ 730 and ≥ 851 counts/15 sec for the vertical axis and vector magnitude, respectively. Sensitivity and specificity were 61%–100% for the developed cut points. The quadratic weighted Kappa showed substantial agreement: κ = 0.79 (95% CI 0.70–0.89) and κ = 0.69 (95% CI 0.56–0.82) for the vertical axis and the vector magnitude, respectively.

Conclusions

This study provides accelerometer cut points based on walking speed for physical-activity measurement in older adults with Parkinson’s disease for evaluation of interventions and for investigating links between physical activity and health.     

Habitual Functional Electrical Stimulation Therapy Improves Gait Kinematics and Walking Performance,but Not Patient-Reported Functional Outcomes,of People with Multiple Sclerosis who Present with Foot-Drop

Background

People with Multiple Sclerosis (pwMS) often experience a disturbed gait function such as foot-drop. The objective of this pilot study was to investigate the medium term effects of using Functional Electrical Stimulation (FES) to treat foot-drop over a period 12 weeks on gait and patient reported outcomes of pwMS.

Methods and Findings

Nine pwMS aged 35 to 64 (2 males, 7 females) were assessed on four occasions; four weeks before baseline, at baseline and after six weeks and twelve weeks of FES use. Joint kinematics and performance on the 10 meter and 2 minute walk tests (10WT, 2 minWT) were assessed with and without FES. Participants also completed the MS walking Scale (MSWS), MS impact scale (MSIS29), Fatigue Severity Score (FSS) and wore an activity monitor for seven days after each assessment. Compared to unassisted walking, FES resulted in statistically significant improvements in peak dorsiflexion in swing (p = 0.006), 10MWT (p = 0.006) and 2 minWT (p = 0.002). Effect sizes for the training effect, defined as the change from unassisted walking at baseline to that at 12 weeks, indicated improved ankle angle at initial contact (2.6°, 95% CI −1° to 4°, d = 0.78), and a decrease in perceived exertion over the 2 min walking tests (−1.2 points, 95% CI −5.7 to 3.4, d = −0.86). Five participants exceeded the Minimally Detectable Change (MDC) for a training effect on the 10mWT, but only two did so for the 2 minWT. No effects of the use of FES for 12 weeks were found for MSWS, MSIS29, FSS or step count.

Conclusion

Although FES to treat foot-drop appears to offer the potential for a medium term training effect on ankle kinematics and walking speed, this was not reflected in the patient reported outcomes. This observed lack of relationship between objective walking performance and patient reported outcomes warrants further investigation.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01977287","term_id":"NCT01977287"}}NCT01977287     

Nordic Walking improves daily physical activities in COPD: a randomised controlled trial

Background

In patients with COPD progressive dyspnoea leads to a sedentary lifestyle. To date, no studies exist investigating the effects of Nordic Walking in patients with COPD. Therefore, the aim was to determine the feasibility of Nordic Walking in COPD patients at different disease stages. Furthermore we aimed to determine the short- and long-term effects of Nordic Walking on COPD patients'' daily physical activity pattern as well as on patients exercise capacity.

Methods

Sixty COPD patients were randomised to either Nordic Walking or to a control group. Patients of the Nordic Walking group (n = 30; age: 62 ± 9 years; FEV₁: 48 ± 19% predicted) underwent a three-month outdoor Nordic Walking exercise program consisting of one hour walking at 75% of their initial maximum heart rate three times per week, whereas controls had no exercise intervention. Primary endpoint: daily physical activities (measured by a validated tri-axial accelerometer); secondary endpoint: functional exercise capacity (measured by the six-minute walking distance; 6MWD). Assessment time points in both groups: baseline, after three, six and nine months.

Results

After three month training period, in the Nordic Walking group time spent walking and standing as well as intensity of walking increased (Δ walking time: +14.9 ± 1.9 min/day; Δ standing time: +129 ± 26 min/day; Δ movement intensity: +0.40 ± 0.14 m/s²) while time spent sitting decreased (Δ sitting time: -128 ± 15 min/day) compared to baseline (all: p < 0.01) as well as compared to controls (all: p < 0.01). Furthermore, 6MWD significantly increased compared to baseline (Δ 6MWD: +79 ± 28 meters) as well as compared to controls (both: p < 0.01). These significant improvements were sustained six and nine months after baseline. In contrast, controls showed unchanged daily physical activities and 6MWD compared to baseline for all time points.

Conclusions

Nordic Walking is a feasible, simple and effective physical training modality in COPD. In addition, Nordic Walking has proven to positively impact the daily physical activity pattern of COPD patients under short- and long-term observation.

Clinical trial registration

Nordic Walking improves daily physical activities in COPD: a randomised controlled trial - ISRCTN31525632     

An Objective Fluctuation Score for Parkinson's Disease

Introduction

Establishing the presence and severity of fluctuations is important in managing Parkinson’s Disease yet there is no reliable, objective means of doing this. In this study we have evaluated a Fluctuation Score derived from variations in dyskinesia and bradykinesia scores produced by an accelerometry based system.

Methods

The Fluctuation Score was produced by summing the interquartile range of bradykinesia scores and dyskinesia scores produced every 2 minutes between 0900-1800 for at least 6 days by the accelerometry based system and expressing it as an algorithm.

Results

This Score could distinguish between fluctuating and non-fluctuating patients with high sensitivity and selectivity and was significant lower following activation of deep brain stimulators. The scores following deep brain stimulation lay in a band just above the score separating fluctuators from non-fluctuators, suggesting a range representing adequate motor control. When compared with control subjects the score of newly diagnosed patients show a loss of fluctuation with onset of PD. The score was calculated in subjects whose duration of disease was known and this showed that newly diagnosed patients soon develop higher scores which either fall under or within the range representing adequate motor control or instead go on to develop more severe fluctuations.

Conclusion

The Fluctuation Score described here promises to be a useful tool for identifying patients whose fluctuations are progressing and may require therapeutic changes. It also shows promise as a useful research tool. Further studies are required to more accurately identify therapeutic targets and ranges.     

Psychosocial and Environmental Correlates of Walking,Cycling, Public Transport and Passive Transport to Various Destinations in Flemish Older Adolescents

Background

Active transport is a convenient way to incorporate physical activity in adolescents’ daily life. The present study aimed to investigate which psychosocial and environmental factors are associated with walking, cycling, public transport (train, tram, bus, metro) and passive transport (car, motorcycle, moped) over short distances (maximum eight kilometres) among older adolescents (17–18 years), to school and to other destinations.

Methods

562 older adolescents completed an online questionnaire assessing socio-demographic variables, psychosocial variables, environmental variables and transport to school/other destinations. Zero-inflated negative binomial regression models were performed.

Results

More social modelling and a higher residential density were positively associated with walking to school and walking to other destinations, respectively. Regarding cycling, higher self-efficacy and a higher social norm were positively associated with cycling to school and to other destinations. Regarding public transport, a higher social norm, more social modelling of siblings and/or friends, more social support and a higher land use mix access were positively related to public transport to school and to other destinations, whereas a greater distance to school only related positively to public transport to school. Regarding passive transport, more social support and more perceived benefits were positively associated with passive transport to school and to other destinations. Perceiving less walking and cycling facilities at school was positively related to passive transport to school only, and more social modelling was positively related to passive transport to other destinations.

Conclusions

Overall, psychosocial variables seemed to be more important than environmental variables across the four transport modes. Social norm, social modelling and social support were the most consistent psychosocial factors which indicates that it is important to target both older adolescents and their social environment in interventions promoting active transport. Walking or cycling together with siblings or friends has the potential to increase social norm, social modelling and social support towards active transport.     

Endobronchial Coils for Severe Emphysema Are Effective Up to 12 Months following Treatment: Medium Term and Cross-Over Results from a Randomised Controlled Trial

Background

There is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. Endobronchial Coils (coils) are nitinol devices implanted bronchoscopically under fluoroscopic guidance to re-tension the lung. We report the medium term effectiveness and safety of coils in a study of patients with emphysema.

Methods

Forty five subjects with severe airflow obstruction and hyperinflation received bilateral sequential treatment with coils (30 day interval between treatments) as part of a randomised controlled trial with a primary endpoint 90 days after the final treatment (Clinicaltrials.gov NCT01334307). Further assessments were made at 180 and 360 days and in this study the primary outcome was the effect of coil treatment on the St. George’s Respiratory Questionnaire (SGRQ) 360 days following treatment.

Results

At 360 days following treatment, there was an improvement in the SGRQ score of -6.1±14.0 points (p = 0.01) compared to baseline. Improvements in secondary outcomes were seen with increases in forced expiratory volume in the first second of 8.9 ±22.2% (p = 0.002) and 6-minute walking distance of 34.1±52.4m (p = 0.003). The safety profile was acceptable out to 360 days post-treatment.

Conclusions

Statistically and clinically meaningful benefits in quality of life, exercise capacity and pulmonary function in patients treated with coils are sustained twelve months after treatment.

Trial registration information

Clinicaltrials.gov NCT01334307.     

Measuring Intensity of End of Life Care: A Systematic Review

Background

Many studies have measured the intensity of end of life care. However, no summary of the measures used in the field is currently available.

Objectives

To summarise features, characteristics of use and reported validity of measures used for evaluating intensity of end of life care.

Methods

This was a systematic review according to PRISMA guidelines. We performed a comprehensive literature search in Ovid Medline, Embase, The Cochrane Library of Systematic Reviews and reference lists published between 1990-2014. Two reviewers independently screened titles, abstracts, full texts and extracted data. Studies were eligible if they used a measure of end of life care intensity, defined as all quantifiable measures describing the type and intensity of medical care administered during the last year of life.

Results

A total of 58 of 1590 potentially eligible studies met our inclusion criteria and were included. The most commonly reported measures were hospitalizations (n = 44), intensive care unit admissions (n = 39) and chemotherapy use (n = 27). Studies measured intensity of care in different timeframes ranging from 48 hours to 12 months. The majority of studies were conducted in cancer patients (n = 31). Only 4 studies included information on validation of the measures used. None evaluated construct validity, while 3 studies considered criterion and 1 study reported both content and criterion validity.

Conclusions

This review provides a synthesis to aid in choosing intensity of end of life care measures based on their previous use but simultaneously highlights the crucial need for more validation studies and consensus in the field.     

T Cell Vaccination Benefits Relapsing Progressive Multiple Sclerosis Patients: A Randomized,Double-Blind Clinical Trial

Background

T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled.

Aim

To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial.

Methodology

Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients'' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10–30×10⁶ T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis.

Results

At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (−0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly.

Conclusions

This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01448252","term_id":"NCT01448252"}}NCT01448252     

Rationale,Design and Methods of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men in the Southeastern United States (The MARI Study)

Background

This paper describes the rationale, design, and methodology of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men (MSM) in the Southeastern United States (U.S.; known locally simply as the MARI Study).

Methods

Participants are African American MSM aged 18 years and older residing in the deep South.

Results

Between 2013 and 2015, 800 African American MSM recruited from two study sites (Jackson, MS and Atlanta, GA) will undergo a 1.5-hour examination to obtain anthropometric and blood pressure measures as well as to undergo testing for sexually transmitted infections (STI), including HIV. Intrapersonal, interpersonal, and environmental factors are assessed by audio computer-assisted self-interview survey. Primary outcomes include sexual risk behaviors (e.g., condomless anal sex) and prevalent STIs (HIV, syphilis, gonorrhea, and Chlamydia).

Conclusion

The MARI Study will typify the HIV environmental ''riskscape'' and provide empirical evidence into novel ecological correlates of HIV risk among African American MSM in the deep South, a population most heavily impacted by HIV. The study''s anticipated findings will be of interest to a broad audience and lead to more informed prevention efforts, including effective policies and interventions, that achieve the goals of the updated 2020 U.S. National HIV/AIDS Strategy.     

Disability Affects the 6-Minute Walking Distance in Obese Subjects (BMI>40 kg/m2)

Introduction

In obese subjects, the relative reduction of the skeletal muscle strength, the reduced cardio-pulmonary capacity and tolerance to effort, the higher metabolic costs and, therefore, the increased inefficiency of gait together with the increased prevalence of co-morbid conditions might interfere with walking. Performance tests, such as the six-minute walking test (6MWT), can unveil the limitations in cardio-respiratory and motor functions underlying the obesity-related disability. Therefore the aims of the present study were: to explore the determinants of the 6-minute walking distance (6MWD) and to investigate the predictors of interruption of the walk test in obese subjects.

Methods

Obese patients [body mass index (BMI)>40 kg/m²] were recruited from January 2009 to December 2011. Anthropometry, body composition, specific questionnaire for Obesity-related Disabilities (TSD-OC test), fitness status and 6MWT data were evaluated. The correlation between the 6MWD and the potential independent variables (anthropometric parameters, body composition, muscle strength, flexibility and disability) were analysed. The variables which were singularly correlated with the response variable were included in a multivariated regression model. Finally, the correlation between nutritional and functional parameters and test interruption was investigated.

Results

354 subjects (87 males, mean age 48.5±14 years, 267 females, mean age 49.8±15 years) were enrolled in the study. Age, weight, height, BMI, fat mass and fat free mass indexes, handgrip strength and disability were significantly correlated with the 6MWD and considered in the multivariate analysis. The determination coefficient of the regression analysis ranged from 0.21 to 0.47 for the different models. Body weight, BMI, waist circumference, TSD-OC test score and flexibility were found to be predictors of the 6MWT interruption.

Discussion

The present study demonstrated the impact of disability in obese subjects, together with age, anthropometric data, body composition and strength, on the 6-minute walking distance.     

Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial

Objective

To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H²) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP).

Design

Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention.

Setting

Community-based and patient-centered self-care for behavioral intervention in urban settings of China.

Participants

A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H² plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients).

Intervention

KM2H² is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke.

Outcome Measures

Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention.

Results

Relative to the standard care, receiving KM2H² was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively.

Conclusion

The program KM2H² is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication. Findings of this study provide solid data supporting a formal phase-III trial to establish the effectiveness of KM2H² for use in community settings for prevention.

Trial Registration

ISRCTN Register ISRCTN12608966