An interventional study of Task-specific training and Global stretching, memory exercises, health care orientation in Stroke, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment
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 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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Task-specific training
Other: Task-specific training
Global stretching, memory exercises, health care orientation
Other: Global stretching, memory exercises, health care orientation
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.
Also known as: Task-oriented training
The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation
Change from baseline in Physical activity levels - physical activity monitor
Physical activity levels will be assessed by a physical activity monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Physical activity levels - Human Activity Profile
Physical activity levels will be assessed by Human Activity Profile.
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Mobility - Gait speed
Mobility will be assessed by gait speed.
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Mobility - TEMPA
Mobility will be assessed by TEMPA test.
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Muscle strength
Muscle strength will be assessed by hydraulic handgrip dynamometer SAEHAN® (SAEHAN Corporation, Korea, Model SH5001) and digital handheld dynamometer Microfet2® (Hoggan Health Industries, UT, USA).
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Exercise capacity
Exercise capacity will be assessed by six minute walk test.
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Quality of life
Quality of life will be assessed by Stroke specific quality of life.
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Federal University of Minas Gerais