Promoting Physical Activity After Stroke Via Self-management

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461976
• Other study ID #: 65672517.6.0000.5149
• Status: Completed
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: October 21, 2023

Study information

• Verified date: November 2023
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 21, 2023
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Brazil	Aline Alvim Scianni	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body mass index	body mass index (BMI) (weight and height will be combined to report BMI in kg/m^2)	3 months, and 6 months
Secondary	Waist circumference	waist circumference (centimeters)	3 months, and 6 months
Secondary	Blood pressure	systolic and diastolic blood pressure (millimeters of mercury)	3 months, and 6 months
Secondary	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.	3 months, and 6 months
Secondary	Walking capacity	Will be measured through the distance covered in the 6-Minute Walk Test.	3 months, and 6 months
Secondary	Walking speed	Will be measured through the comfortable and maximum walking speed, with the 10- Meter Walk Test.	3 months, and 6 months
Secondary	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.	3 months, and 6 months
Secondary	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.	3 months, and 6 months
Secondary	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.	3 months, and 6 months