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Physical InactivityPA-strokeNCT06597929

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

A study testing Moderate-vigorous physical activity in people with Physical Inactivity and Stroke, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Physical Inactivity, Stroke
What is being tested?
Moderate-vigorous physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSpain
Study dates
1 Apr 2025to 20 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Sant Cugat del Valles

    Barcelona, Catalonia, 08195

Other trials in Spain

About this study

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)

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.

Read the 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.

Being tested
Moderate-vigorous physical activity
Keywords
Physical activity, Stroke, Moderate-vigorous physical activity
Medical subject headings
Sedentary Behavior, Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderate-vigorous physical activityOther

    Also called Moderate-vigorous exercise

    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.

Study groups in NCT06597929
Study groupRoleWhat they receive
Usual care plus the MV-ILPA and education program.ExperimentalThe 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.
Receives: Other: Moderate-vigorous physical activity
Usual careActive comparatorUsual 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.
Receives: Other: Moderate-vigorous physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment T0 (during 7 days) to the end of treatment at 12 weeks T1 (during 7 days) and at 12 weeks (follow-up) T2 (during 7 days)

Secondary outcomes (11)
  1. Lower limb mean power

    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.

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  2. Balance

    It will be assess by Berg Balance Scale, 0-56 points higher scores means better outcome

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up

  3. Gait speed (comfortable and fast pace)

    4-metre walk test, less time mean better outcome

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  4. Fatigue

    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.

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

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

    It will be assess by EuroQol 5-dimension 5-level. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Each dimension of EQ-5D is described by 5 possible levels, scoring from 0 to 25 points. Higher score means worse outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  6. Degree of disability

    Modified-Rankin Scale, single-item global outcomes rating scale, from 0 to 5. Higher score means worse outcome.

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  7. Stroke recurrence

    yes/no, date

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  8. Death

    yes/no, date

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  9. Falls

    number of falls

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  10. Leg strength and endurance by 30 seconds sit to stand test

    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.

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

  11. Basic Activities of daily living (Fundamental Self-Care)

    Barthel Index: Evaluates a person's functional status by measuring their ability to perform basic self-care tasks as: Bathing \& Hygiene: Washing body, brushing teeth, and grooming.Dressing: Selecting clothing and physically putting it on.Toileting: Getting to the toilet, using it, and cleaning oneself.Transferring: Moving in and out of a bed or chair.Continence: Managing bowel and bladder control.Feeding: Physically bringing food into the body (though preparing the food falls under IADLs).

    Measured: Day 0 T0, at 12-week T1 and 24-week follow-up T2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Apr 2025
  3. Primary completion20 Jan 2026
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06597929
Sponsor's protocol ID
M-VILPA-stroke
Acronym
PA-stroke
Status last verified
Jan 2026
First submitted
11 Sep 2024
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36696822
  • 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.

    PubMed 37548025
  • 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.

    PubMed 39172127
  • 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.

    PubMed 36822187
  • 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.

    PubMed 37498576

Questions about this trial

What is this clinical trial studying?

A study testing Moderate-vigorous physical activity in people with Physical Inactivity and Stroke, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The amount of moderate-vigorous intense physical activity (PA). (time frame: From enrollment T0 (during 7 days) to the end of treatment at 12 weeks T1 (during 7 days) and at 12 weeks (follow-up) T2 (during 7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06597929, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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