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

April 21, 2026 updated by: Rosa Cabanas Valdés, Universitat Internacional de Catalunya

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08195
        • Sant Cugat del Valles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usual care plus the MV-ILPA and education program.
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
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.
Other Names:
  • Moderate-vigorous exercise
Active Comparator: Usual care
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
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.
Other Names:
  • Moderate-vigorous exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of moderate-vigorous intense physical activity (PA).
Time Frame: From enrollment to the end of treatment at 12 weeks (during 7 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Day 0 and Month 3
It will be assess by Berg Balance Scale, 0-56 points higher scores means better outcome
Day 0 and Month 3
Gait speed
Time Frame: Day 0 and Month 3
4-metre walk test, less time mean better outcome
Day 0 and Month 3
Fatigue
Time Frame: Day 0 and Month 3
Fatigue Severity Scale, a 9-item questionnaire The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher score means worse outcome.
Day 0 and Month 3
Quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time Frame: Day 0 and Month 3
It will be assess by EuroQol 5-dimension 5-level. Each dimension is described by 5 possible levels, scoring from 0 to 25 points. Higher score means worse outcome.
Day 0 and Month 3
Degree of disability
Time Frame: Day 0 and Month 3
Modified-Rankin Scale, single-item global outcomes rating scale, from 0 to 5. Higher score means worse outcome.
Day 0 and Month 3
Stroke recurrence
Time Frame: Day 0 and Month 3
yes/no, date
Day 0 and Month 3
Death
Time Frame: Day 0 and Month 3
yes/no, date
Day 0 and Month 3
Lower limb mean power
Time Frame: Day 0 and Month 3

The participants were instructed to rise from the chair, without armrests, as fast and powerful as possible, reaching a fully standing erect position without lifting their feet and sit back down as quickly as possible. Five attempts were given interspersed by 30-60 s. It is measured by Lineal Encoder Chronojump.

Higher mean power means better outcome.
Day 0 and Month 3
Falls
Time Frame: Day 0 and Month 3 From enrollment to the end of treatment at 12 weeks
yes/no, date
Day 0 and Month 3 From enrollment to the end of treatment at 12 weeks
Leg strength and endurance by 30 seconds sit to stand test
Time Frame: From enrollment to the end of treatment at 12 weeks

The Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving.The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest.Demonstrate the task both slowly and quickly.

Have the patient practice a repetition or two before completing the test. If a patient must use their arms to complete the test, they are scored 0. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.

While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Collaborators

Corporacion Parc Tauli
Hospital de Granollers
Hospital de Terrassa
Hospital de la Santa Creu de Vic

Investigators

  • Principal Investigator: Rosa Cabanas-Valdés, PhD, Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

January 20, 2026

Study Completion (Actual)

April 20, 2026

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-VILPA-stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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