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Promoting Physical Activity After Stroke Via Self-management

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Home-based self-management exercise program
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, self-management, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aline Alvim Scianni

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home-based self-management exercise program

Control Group

Arm Description

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.

This group will receive one session about education on risk factors after stroke and usual care.

Outcomes

Primary Outcome Measures

Change from baseline physical activity level at 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

Body mass index
body mass index (BMI) (weight and height will be combined to report BMI in kg/m^2)
Waist circumference
waist circumference (centimeters)
Blood pressure
systolic and diastolic blood pressure (millimeters of mercury)
Depression
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.
Walking capacity
Will be measured through the distance covered in the 6-Minute Walk Test.
Walking speed
Will be measured through the comfortable and maximum walking speed, with the 10- Meter Walk Test.
Self-Efficacy for exercise
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.
Social participation
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.
Perception of quality of life
Will be measured through EuroQual-5D. The results will be expressed in scores of 0-100. The 0 is the worse score.

Full Information

First Posted
July 6, 2022
Last Updated
August 17, 2023
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT05461976
Brief Title
Promoting Physical Activity After Stroke Via Self-management
Official Title
A Randomized, Controlled Pilot Study of a Home-based Self-management Exercise Program for Sedentary Individuals With Mild Disability After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, self-management, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based self-management exercise program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will receive one session about education on risk factors after stroke and usual care.
Intervention Type
Behavioral
Intervention Name(s)
Home-based self-management exercise program
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline physical activity level at 3 months and 6 months
Description
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.
Time Frame
3 months, and 6 months
Secondary Outcome Measure Information:
Title
Body mass index
Description
body mass index (BMI) (weight and height will be combined to report BMI in kg/m^2)
Time Frame
3 months, and 6 months
Title
Waist circumference
Description
waist circumference (centimeters)
Time Frame
3 months, and 6 months
Title
Blood pressure
Description
systolic and diastolic blood pressure (millimeters of mercury)
Time Frame
3 months, and 6 months
Title
Depression
Description
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.
Time Frame
3 months, and 6 months
Title
Walking capacity
Description
Will be measured through the distance covered in the 6-Minute Walk Test.
Time Frame
3 months, and 6 months
Title
Walking speed
Description
Will be measured through the comfortable and maximum walking speed, with the 10- Meter Walk Test.
Time Frame
3 months, and 6 months
Title
Self-Efficacy for exercise
Description
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.
Time Frame
3 months, and 6 months
Title
Social participation
Description
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.
Time Frame
3 months, and 6 months
Title
Perception of quality of life
Description
Will be measured through EuroQual-5D. The results will be expressed in scores of 0-100. The 0 is the worse score.
Time Frame
3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aline Alvim Scianni
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
30700139
Citation
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available. Erratum In: Circulation. 2020 Jan 14;141(2):e33.
Results Reference
background
PubMed Identifier
34024117
Citation
Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available. Erratum In: Stroke. 2021 Jul;52(7):e483-e484.
Results Reference
background
PubMed Identifier
28523989
Citation
D'Isabella NT, Shkredova DA, Richardson JA, Tang A. Effects of exercise on cardiovascular risk factors following stroke or transient ischemic attack: a systematic review and meta-analysis. Clin Rehabil. 2017 Dec;31(12):1561-1572. doi: 10.1177/0269215517709051. Epub 2017 May 19.
Results Reference
background
PubMed Identifier
25927591
Citation
Jones TM, Dean CM, Hush JM, Dear BF, Titov N. A systematic review of the efficacy of self-management programs for increasing physical activity in community-dwelling adults with acquired brain injury (ABI). Syst Rev. 2015 Apr 19;4:51. doi: 10.1186/s13643-015-0039-x.
Results Reference
background
PubMed Identifier
34581249
Citation
Caetano LC, Ada L, Romeu Vale S, Teixeira-Salmela LF, Scianni AA. Self-management to promote physical activity after discharge from in-patient stroke rehabilitation: a feasibility study. Top Stroke Rehabil. 2023 Jan;30(1):32-42. doi: 10.1080/10749357.2021.1978630. Epub 2021 Sep 28.
Results Reference
background

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Promoting Physical Activity After Stroke Via Self-management

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