Moderate-vigorous Intermittent Physical Activity (M-VILPA) in Stroke

NCT06597929 | Completed

• 1 other identifier: M-VILPA-stroke
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity; Stroke

Keywords

Physical activity; Stroke; Moderate-vigorous physical activity

Outcome Measures

Primary Outcomes (1)

• The amount of moderate-vigorous intense physical activity (PA).

  All participants will be monitored with a 3-axial accelerometer (strapped on the waist) for 7 days to record their total daily movement counts and the minutes of moderate-to-vigorous-intensity PA.

  From enrollment to the end of treatment at 12 weeks (during 7 days)

Secondary Outcomes (10)

• Lower limb mean power

  Day 0 and Month 3

• Balance

  Day 0 and Month 3

• Gait speed

  Day 0 and Month 3

• Fatigue

  Day 0 and Month 3

• Quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  Day 0 and Month 3

Study Arms (2)

Usual care plus the MV-ILPA and education program.

EXPERIMENTAL

The experimental group will receive usual care plus the MV-ILPA and education program. First, a physiotherapist will conduct a face-to-face session with the patients detailing the health benefits of moderate to vigorous PA and the negative effects of not including it in their daily lives. Patients will receive a booklet with all the key information. Secondly, participants will take the MV-ILPA program.

Other: Moderate-vigorous physical activity

Usual care

ACTIVE COMPARATOR

Usual care: appointments with the treating neurologist, medication, conventional physiotherapy (two/three times a week, including stretching, strength, and balance training), occupational therapy, and speech therapy if required.

Other: Moderate-vigorous physical activity

Interventions

Moderate-vigorous physical activity OTHER

The experimental group will receive usual care plus the MV-ILPA and education program. First, a physiotherapist will conduct a face-to-face session with the patients detailing the health benefits of moderate to vigorous PA and the negative effects of not including it in their daily lives. Patients will receive a booklet with all the key information. Secondly, participants will take the MV-ILPA program. This program consists of completing 4 length-standardised moderate-to-vigorous intense bouts per day (3 minutes each) of activities of daily living (sit-to-stand, going up/down stairs, walking fast indoors, and walking up small slopes) every day for 12 weeks. Once per week for 12 weeks, a physiotherapist will go to the patient\'s home for a face-to-face session or videoconference. This physiotherapist will foster participants' independence and self-management. The PA intensity will be increased weekly by increasing the execution speed and including weights.

Also known as: Moderate-vigorous exercise

Usual care; Usual care plus the MV-ILPA and education program.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged ≥50 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Corporacion Parc Tauli: collaborator
• Hospital de la Santa Creu de Vic: collaborator
• Hospital de Terrassa: collaborator
• Hospital de Granollers: collaborator

Study Sites (1)

Sant Cugat del Valles

Barcelona, Catalonia, 08195, Spain

Location

Related Publications (5)

• 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.

  PMID: 36696822 BACKGROUND

• 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.

  PMID: 37548025 BACKGROUND

• 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.

  PMID: 39172127 BACKGROUND

• 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.

  PMID: 36822187 BACKGROUND

• 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.

  PMID: 37498576 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Stroke; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Rosa Cabanas-Valdés, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

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: PhD

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)