Promoting Physical Activity After Stroke Via Self-management

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT05461976
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Study Start: 2022-08-11
• Primary Completion: 2023-10-21
• Study Completion: 2023-10-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline physical activity level at 3 months and 6 months	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 Outcome Measures

Name	Time	Method
Body mass index	3 months, and 6 months	body mass index (BMI) (weight and height will be combined to report BMI in kg/m\^2)
Waist circumference	3 months, and 6 months	waist circumference (centimeters)
Walking speed	3 months, and 6 months	Will be measured through the comfortable and maximum walking speed, with the 10- Meter Walk Test.
Social participation	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.
Blood pressure	3 months, and 6 months	systolic and diastolic blood pressure (millimeters of mercury)
Self-Efficacy for exercise	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.
Walking capacity	3 months, and 6 months	Will be measured through the distance covered in the 6-Minute Walk Test.
Depression	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.
Perception of quality of life	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.

Trial Locations

Locations (1)

Aline Alvim Scianni; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil