Promoting Physical Activity After Stroke Via Self-management

NCT05461976 | Completed

• 1 other identifier: 65672517.6.0000.5149
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; self-management; physical activity

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months, and 6 months

Secondary Outcomes (9)

• Body mass index

  3 months, and 6 months

• Waist circumference

  3 months, and 6 months

• Blood pressure

  3 months, and 6 months

• Depression

  3 months, and 6 months

• Walking capacity

  3 months, and 6 months

Study Arms (2)

Home-based self-management exercise program

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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.

Home-based self-management exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Aline Alvim Scianni

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (7)

• 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.

  PMID: 30700139 BACKGROUND

• 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.

  PMID: 34024117 BACKGROUND

• 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.

  PMID: 28523989 BACKGROUND

• 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.

  PMID: 25927591 BACKGROUND

• 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.

  PMID: 34581249 BACKGROUND

• Alvarenga MTM, Ada L, Preston E, Sant'ana RV, Teixeira-Salmela LF, Scianni AA. Home-based self-management for physically inactive individuals with mild walking disability after stroke: a randomised pilot study. Disabil Rehabil. 2025 Nov;47(22):5780-5787. doi: 10.1080/09638288.2025.2489762. Epub 2025 Apr 12.

  PMID: 40219905 DERIVED

• Alvarenga MTM, Ada L, Preston E, Caetano LCG, Teixeira-Salmela LF, Scianni AA. Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study. BMC Neurol. 2023 Nov 20;23(1):412. doi: 10.1186/s12883-023-03461-7.

  PMID: 37986149 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Physical Therapy Department

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 18, 2022
• Study Start: August 11, 2022
• Primary Completion: October 21, 2023
• Study Completion: October 21, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)