Clinical trial NCT02937480: Efficacy of Task-specific Training on Physical Activity Levels Post-stroke
Official title: Efficacy of Task-specific Training on Physical Activity Levels of People With Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
physical activity
task performance
clinical protocol
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2016-10-18
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The majority of people after stroke demonstrate mobility limitations, which may reduce their physical activity levels. Task-specific training has shown to be an effective intervention to improve mobility in individuals with stroke, however, little is known about the impact of this intervention on levels of physical activity. The main objective will be to investigate the efficacy of a task-specific training, focused on both upper and lower limbs, in improving physical activity levels and mobility in individuals with stroke. The secondary objective will be to investigate the effect of the training, in improving muscle strength, exercise capacity, and quality of life. A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) experimental group or 2) control group. Participants will receive interventions three times per week over 12 weeks. The experimental group will undertake task-specific training, while the control group will undertake global stretching and memory exercises, and health education sessions. Primary outcomes will include measures of physical activity levels and mobility, whereas secondary outcomes will be muscle strength, exercise capacity, and quality of life. The outcomes will be measured at baseline, 12 weeks post-intervention, and four and 12 weeks follow-up. The findings of this trial have the potential to provide important insights regarding the effects of task-specific training, focused on both upper and lower limbs, in preventing secondary post-stroke complications and improving the participants' general health through changes in physical activity levels.

Detailed description: The sample size was calculated to detect a between-group difference of 0.15 m/s in gait speed, with 80% power, at a two-tailed significance level of 0.05. In an RCT with a similar population and intervention (Yang et al. 2006) gait speed for the control and experimental groups at baseline was 0.78±0.14 m/s and 0.84±0.13 m/s and after were 0.78±0.15 m/s (p=0.8) and 0.93±0.14 m/s (p\<.001), respectively. Based on these values, 15 participants per group will be required (a total of 30 participants). Assuming a dropout rate of 15%,66 a total of 36 participants will be recruited (18 per group).

Data analyses will be performed by the SPSS for Windows® (release 17.0, SPSS Inc., Chicago, IL, USA). Descriptive statistics will be carried-out for all outcome variables. Differences between the groups at baseline will be investigated with the independent Student's t-tests for all variables related to the demographic and clinical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors.

The effects of the interventions will be analysed in two ways, namely from the data collected and by intention-to-treat analyses, where the last available value in the dropouts will be carried forward to represent the missing data. Analyses of variance with repeated measures (2×4) will be employed to investigate the mean and interaction effects between the groups (intervention×control) and the time (preintervention, postintervention, and follow-up) for the primary and secondary outcomes. Group descriptions will be presented as mean (SD) and effect sizes with 95% confidence intervals (CIs) will be reported.

The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.

Eligibility criteria: Inclusion Criteria:

* have a clinical diagnosis of first or recurrent stroke more than six months since the onset of their strokes;
* are older than 19 years of age;
* are able to independently walk 10 m with or without walking aid devices;
* have tone of elbow flexor muscles below 4 on modified Ashworth scale;
* are inactive or insufficient, based on Centers for Disease Control and Prevention criteria;
* get medical permission for physical activity practice

Exclusion Criteria:

* have severe cognitive deficits, as assessed by the mini-mental state exam and/or language problems (comprehensive afasia), as evaluated by simple motor commands ("lift your nonparetic upper limb and open your hand"), which might prevent them from following instructions during the data collection and/or the interventions;
* have history of severe heart disease and/or uncontrolled blood pressure;
* have pain and/or other adverse health conditions which might affect the performance in the intervention program, such as vestibular disturbances, severe arthritis, or other neurological disorders.

Primary outcomes:
measure: Change from baseline in Physical activity levels - physical activity monitor
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
measure: Change from baseline in Physical activity levels - Human Activity Profile
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
measure: Change from baseline in Mobility - Gait speed
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
measure: Change from baseline in Mobility - TEMPA
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Secondary outcomes:
measure: Change from baseline in Muscle strength
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
measure: Change from baseline in Exercise capacity
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
measure: Change from baseline in Quality of life
timeFrame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Christina Danielli CM Faria, Doctor
role: PRINCIPAL_INVESTIGATOR
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