Efficacy of Task-specific Training on Physical Activity Levels Post-stroke

December 16, 2019 updated by: Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais

Efficacy of Task-specific Training on Physical Activity Levels of People With Stroke: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31270-901
        • Federal University of Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Task-specific training
Other: Task-specific training
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.
Other Names:
  • Task-oriented training
Sham Comparator: Control group
Global stretching, memory exercises, health care orientation
Other: Global stretching, memory exercises, health care orientation
The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Physical activity levels - physical activity monitor
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Physical activity levels will be assessed by a physical activity monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Physical activity levels - Human Activity Profile
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Physical activity levels will be assessed by Human Activity Profile.
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Mobility - Gait speed
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Mobility will be assessed by gait speed.
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Mobility - TEMPA
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Mobility will be assessed by TEMPA test.
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Muscle strength
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
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).
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Exercise capacity
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Exercise capacity will be assessed by six minute walk test.
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Quality of life
Time Frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Quality of life will be assessed by Stroke specific quality of life.
At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais

Investigators

  • Principal Investigator: Christina Danielli CM Faria, Doctor, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

September 18, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 51453915.1.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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