Clinical trial NCT06597929: Moderate-vigorous Intermittent Physical Activity (M-VILPA) in Stroke
Official title: The Effectiveness of Moderate-vigorous Intermittent Lifestyle Physical Activity and Health Education to Increase Intense Physical Activity in Stroke Survivors: a Pragmatic Randomised Controlled Trial (MV-ILPA-stroke)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Stroke
Keywords: Physical activity
Stroke
Moderate-vigorous physical activity
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 57
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the leading cause of disability in Spain. Additionally, it is the second leading cause of death in women and the third in both sexes. Regular physical activity (PA) helps prevent and manage stroke. It also helps with hypertension, maintains a healthy body weight, and improves mental health, quality of life, and well-being. PA plays a prominent role in inpatient care after stroke. However, stroke survivors become more sedentary when discharged from the hospital. They have muscle weakness, reduced balance, and fatigue. Consequently, PA levels of community-dwelling post-stroke individuals remain lower than their age-matched counterparts. Continued PA can help this population maintain and improve physical function, and reduce long-term functional limitations, and mortality risk.

Detailed description: Previous studies that performed a comparative analysis of physical activity between individuals with and without stroke have consistently reported that stroke survivors tend to spend less time in moderate to vigorous physical activity The 2021 AHA guideline recommends smaller sessions of PA, with suggestions such as 10 minutes of moderate activity, 4 times a week, or 20 minutes of vigorous activity twice a week. This contrasts the weekly physical activity recommendations in 2011 (30 minutes of moderate to vigorous, 1 to 3 times) and 2014 (40 minutes of moderate to vigorous, 3 to 4 times). We hypothesise that older stroke survivors are physically active more frequently but for smaller durations than younger stroke survivors who are physically active for longer durations but less regularly. Understanding these subtle changes will not only help to tailor physical activity interventions based on specific recommendations but also help design future recommendations.

Moderate-to-vigorous PA could be an adequate approach for stroke survivors as it requires less time to achieve the same benefits as light PA. More concretely, a new concept called moderate-to-vigorous intermittent lifestyle physical activity (MV-ILPA) has recently emerged for adults who do not habitually exercise in their leisure time. MV-ILPA refers to brief and sporadic bouts of moderate-vigorous intensity PA performed as part of the activities of daily living, such as bursts of very fast walking, sitting and standing up from a chair, or stair climbing. MV-ILPA is associated with a substantially lower risk of all-cause cardiovascular disease and cancer mortality. However, there is no evidence to directly support the potential benefits of MV-ILPA in the elderly post-stroke patients.

Eligibility criteria: Inclusion Criteria:

* adults aged ≥57 in the late subacute phase post-stroke.
* who live in the community
* whose clinician confirmed a diagnosis of stroke (ischaemic/haemorrhagic)
* discharged from hospital inpatient regimen
* with independent mobility skills (Barthel Index ≥ 40 points).

Exclusion Criteria:

• other neurological diseases (e.g. Parkinson disease) or severe lower limb injuries.

Primary outcomes:
measure: The amount of moderate-vigorous intense physical activity (PA).
timeFrame: The measurements will be performed during the week before Day 0 and Month 3.
Secondary outcomes:
measure: Lower limb peak power
timeFrame: Day 0 and Month 3
measure: Balance
timeFrame: Day 0 and Month 3
measure: Gait speed
timeFrame: Day 0 and Month 3
measure: Fatigue
timeFrame: Day 0 and Month 3
measure: Quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
timeFrame: Day 0 and Month 3
measure: Degree of disability
timeFrame: Day 0 and Month 3
measure: Stroke recurrence
timeFrame: Day 0 and Month 3
measure: Death
timeFrame: Day 0 and Month 3
measure: Falls
timeFrame: Day 0 and Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Rosa Cabanas-Valdés, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabanas-Valdes R, Garcia-Rueda L, Salgueiro C, Perez-Bellmunt A, Rodriguez-Sanz J, Lopez-de-Celis C. Assessment of the 4-meter walk test test-retest reliability and concurrent validity and its correlation with the five sit-to-stand test in chronic ambulatory stroke survivors. Gait Posture. 2023 Mar;101:8-13. doi: 10.1016/j.gaitpost.2023.01.014. Epub 2023 Jan 20.
citation: Kwakkel G, Stinear C, Essers B, Munoz-Novoa M, Branscheidt M, Cabanas-Valdes R, Lakicevic S, Lampropoulou S, Luft AR, Marque P, Moore SA, Solomon JM, Swinnen E, Turolla A, Alt Murphy M, Verheyden G. Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. Eur Stroke J. 2023 Dec;8(4):880-894. doi: 10.1177/23969873231191304. Epub 2023 Aug 7.
citation: Goncalves S, Le Bourvellec M, Duclos NC, Mandigout S. Recommended moderate to vigorous physical activity levels for people in the chronic phase of stroke can be achieved in outpatient physiotherapy: a multicentre observational study. Top Stroke Rehabil. 2025 Apr;32(3):219-228. doi: 10.1080/10749357.2024.2392447. Epub 2024 Aug 22.
citation: Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wagner E, Ward J, Wasik EP, Whitaker AA, Wright H, Dunning K. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Apr 1;80(4):342-351. doi: 10.1001/jamaneurol.2023.0033.
citation: Stamatakis E, Ahmadi MN, Friedenreich CM, Blodgett JM, Koster A, Holtermann A, Atkin A, Rangul V, Sherar LB, Teixeira-Pinto A, Ekelund U, Lee IM, Hamer M. Vigorous Intermittent Lifestyle Physical Activity and Cancer Incidence Among Nonexercising Adults: The UK Biobank Accelerometry Study. JAMA Oncol. 2023 Sep 1;9(9):1255-1259. doi: 10.1001/jamaoncol.2023.1830.