Clinical trial NCT05461976: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
self-management
physical activity
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Primary outcomes:
measure: Change from baseline physical activity level at 3 months and 6 months
timeFrame: 3 months, and 6 months
Secondary outcomes:
measure: Body mass index
timeFrame: 3 months, and 6 months
measure: Waist circumference
timeFrame: 3 months, and 6 months
measure: Blood pressure
timeFrame: 3 months, and 6 months
measure: Depression
timeFrame: 3 months, and 6 months
measure: Walking capacity
timeFrame: 3 months, and 6 months
measure: Walking speed
timeFrame: 3 months, and 6 months
measure: Self-Efficacy for exercise
timeFrame: 3 months, and 6 months
measure: Social participation
timeFrame: 3 months, and 6 months
measure: Perception of quality of life
timeFrame: 3 months, and 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Aline Alvim Scianni
state: Minas Gerais
Study officials:
References:
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.
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.
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.
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.
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.