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Completed

NCT Number: NCT06597929

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

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Key information

Conditions

Physical Inactivity Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Sedentary Behavior Stroke Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sant Cugat del Valles

Barcelona, Catalonia, 08195, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Moderate-vigorous exercise

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Lower limb mean power

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

    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.

  2. Balance

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

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

  3. Gait speed (comfortable and fast pace)

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

    4-metre walk test, less time mean better outcome

  4. Fatigue

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

    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.

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

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

    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.

  6. Degree of disability

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

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

  7. Stroke recurrence

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

    yes/no, date

  8. Death

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

    yes/no, date

  9. Falls

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

    number of falls

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

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

    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.

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

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

    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).

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Collaborators

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

Registry information

Official study 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)

Acronym: PA-stroke

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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