Promoting Physical Activity After Stroke Via Self-management

November 21, 2023 updated by: Aline Alvim Scianni, Federal University of Minas Gerais

A Randomized, Controlled Pilot Study of a Home-based Self-management Exercise Program for Sedentary Individuals With Mild Disability After Stroke

Practising physical activity after a stroke is essential for the secondary prevention of stroke. However, the major individuals after stroke are sedentary. Individuals after stroke with mild disabilities could have fewer barriers to this practice. Thus, finding ways to promote physical activity after stroke in these individuals is important for them and public health. Interventions that consider behaviour change strategies are a good way to change a habit and could improve physical activity levels. Self-management interventions have been used to promote behaviour change in the stroke population.

The aim of this pilot trial will be to determine the efficacy of a self-management program to increase physical activity levels in stroke survivors with mild disability through 6 home-based sessions of self-management exercise over 3 and 6 months in a low-income country. Our secondary aims are to evaluate the effect of a self-management program on walking, exercise self-efficacy, participation, quality of life, depression and cardiovascular risks after 3 and 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One-quarter of stroke events in the world are recurrent. Stroke secondary prevention is essential for this population and health politics. The practice of a physical activity is a good option to reduce the chance to develop a second stroke. Self-management interventions have been used in the stroke population to increase physical activity. However, a review showed that the efficacy of this intervention to improve physical activity is inconclusive. Recently, a study of feasibility made in Brazil about the self-management approach showed positive results in this intervention to increase physical activity after stroke survivors with mild impairment. In addition, the results can be more beneficial for sedentary individuals. The aim of this study will be to test the efficacy of a home-based self-management exercise intervention to improve physical activity levels in sedentary individuals with a mild disability after stroke. The specific questions are:

In sedentary individuals with a mild disability after stroke,

  1. Is a home-based self-management exercise effective in improving physical activity effective at increasing the number of steps taken per day?
  2. Does any improvement in physical activity carry over to improvements in cardiovascular risk, walking ability, depressive symptoms, exercise self-efficacy, social participation and quality of life?

Study Type

Interventional

Enrollment (Actual)

24

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
        • Aline Alvim Scianni

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • time since stroke less than 6 months;
  • ≥18 years of age;
  • be able to walk 10 meters independently at a speed ≥ 0.8 m/s without any walk devices;
  • had no cognitive impairments (determined by the cut-off scores on the Brazilian version of the Mini-Mental State Examination);
  • be sedentary (steps counts less than 5000 steps/day).

Exclusion Criteria:

  • have other neurological diseases (e.g. Parkinson, Multiple Sclerosis);
  • had comprehensive aphasia (evaluated by simple motor command: "lift your good arm and raise your hand");
  • have any other conditions that would prevent participation.

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: Home-based self-management exercise program
A home-based self-management exercise program will be implemented based on behaviour change techniques on the approach of Social-Cognitive Theory and Control Theory. In the present study, we will use the following behaviour changes techniques: health consequences, action planning, graded tasks, problem-solving/coping planning, modelling of the behaviour, vicarious reinforcement and non-specific encouragement, feedback on behaviour, self-monitoring on behaviour, review behaviour goals and goal setting (behaviour). The program will include six sessions of self-management with an average duration of 60 minutes. The intervention will be delivered individually and face-to-face in the participant's home by a physical therapist over 10 weeks.
Behavioral: Home-based self-management exercise program
Session 1 will includes education about stroke. Session 2 will includes feedback on behaviour performance on initial measurement outcomes, health consequences of the physical inactivity, answering an exercise preferences questionnaire, generation of a list of goals, delivering a smartband and a diary to self-monitoring. Session 3 will includes reviewing of goals and strategies to self-monitoring, encouragement, rising barriers to exercise and potential solutions to them, development of a weekly schedule physical exercise, implementation of the physical exercise session with participant and delivering a paper-exercise guide. Session 4 will includes reviewing of goals and weekly schedule physical exercise, encouragement, problem solving/coping planning, reviewing strategies to self-monitoring and showing to participant a video with another stroke survivors which are physically active. Sessions 5 and 6 will be the same as session 4 with exception of vicarious reinforcement.
No Intervention: Control Group
This group will receive one session about education on risk factors after stroke and usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline physical activity level at 3 months and 6 months
Time Frame: 3 months, and 6 months
We will measure the level of physical activity through steps taken per day using the Actigraph wGT3X-BT. The participants will be informed to use the device during the waking hours, except during water activities.
3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: 3 months, and 6 months
body mass index (BMI) (weight and height will be combined to report BMI in kg/m^2)
3 months, and 6 months
Waist circumference
Time Frame: 3 months, and 6 months
waist circumference (centimeters)
3 months, and 6 months
Blood pressure
Time Frame: 3 months, and 6 months
systolic and diastolic blood pressure (millimeters of mercury)
3 months, and 6 months
Depression
Time Frame: 3 months, and 6 months
Will be measured with the short version of the Geriatric Depression Scale. The results will be expressed in scores of 0-15. The 0 is the worse score.
3 months, and 6 months
Walking capacity
Time Frame: 3 months, and 6 months
Will be measured through the distance covered in the 6-Minute Walk Test.
3 months, and 6 months
Walking speed
Time Frame: 3 months, and 6 months
Will be measured through the comfortable and maximum walking speed, with the 10- Meter Walk Test.
3 months, and 6 months
Perception of quality of life
Time Frame: 3 months, and 6 months
Will be measured through EuroQual-5D. The results will be expressed in scores of 0-100. The 0 is the worse score.
3 months, and 6 months
Self-Efficacy for exercise
Time Frame: 3 months, and 6 months
Will be measured through the Self-Efficacy for Exercise. The results will be expressed in scores of 0-10. The 0 is the worse score.
3 months, and 6 months
Social participation
Time Frame: 3 months, and 6 months
Will be measured through the participation domain of the Stroke Impact Scale. The results will be expressed in percentage 0-100%. Higher percentage demonstrate better social participation levels.
3 months, and 6 months

Collaborators and Investigators

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

Sponsor

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)

August 11, 2022

Primary Completion (Actual)

October 21, 2023

Study Completion (Actual)

October 21, 2023

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65672517.6.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

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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