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Completed

NCT Number: NCT05461976

Promoting Physical Activity After Stroke Via Self-management

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aline Alvim Scianni

Belo Horizonte, Minas Gerais, Brazil

About this study

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,

  • Is a home-based self-management exercise effective in improving physical activity effective at increasing the number of steps taken per day?
  • 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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based self-management exercise program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Waist circumference

    Time frame: 3 months, and 6 months

    waist circumference (centimeters)

  3. Blood pressure

    Time frame: 3 months, and 6 months

    systolic and diastolic blood pressure (millimeters of mercury)

  4. 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.

  5. Walking capacity

    Time frame: 3 months, and 6 months

    Will be measured through the distance covered in the 6-Minute Walk Test.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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