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.
The sample size was calculated considering the results of the Timed Up Go test reported by Yang et al., which involved a task-specific training program with individuals at the chronic phases of stroke. The Timed Up and Go test scores for the control and experimental groups at baseline were 14.3±7s and 14.6±7.4s, and after were 14.4±6.7s and 12.9±6.5s, respectively. Significant within and between-group differences were observed and the difference within the experimental group was -1.7±1.1s. Based upon this value, a sample size of 16 subjects per group, i.e. a total of 32 participants, would be required, considering a significance level (α) of 5% and a power of 0.80. Based on the assumption that about 15% of the participants may drop out during the course of the study, a target of 38 participants in total was set, 19 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 drop-outs will be carried forward to represent the missing data. Analyses of variance with repeated measures (2x4) will be employed to investigate the mean and interaction effects between the groups (intervention x control) and the time (pre-, post-interventions, and follow ups) for the primary physical activity level and mobility outcomes and the following secondary outcomes: muscular strength, exercise capacity, and SSQOL scores. Group descriptions will be presented as means and SD, and effect sizes at 95% confidence intervals 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.
- Task-specific training Other
Other Names: Task-oriented training Intervention Desc: The task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training. ARM 1: Kind: Experimental Label: Experimental group Description: Task-specific training
- Global stretching, memory exercises, health care orientation Other
Intervention Desc: The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation ARM 1: Kind: Experimental Label: Control group Description: Global stretching, memory exercises, health care orientation
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change from baseline in Physical activity levels - physical activity monitor||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Primary||Change from baseline in Physical activity levels - Human Activity Profile||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Primary||Change from baseline in Mobility - Gait speed||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Primary||Change from baseline in Mobility - Timed 'Up and Go' test||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Primary||Change from baseline in Mobility - TEMPA||baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Secondary||Change from baseline in Muscle strength||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Secondary||Change from baseline in Exercise capacity||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|
|Secondary||Change from baseline in Quality of life||At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up||No|