Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06597929

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

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)

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
Universitat Internacional de Catalunya · Academic / Other
Sex
All
Age
57 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERModerate-vigorous physical activityThe 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.

Timeline

Start date
2025-04-01
Primary completion
2026-01-01
Completion
2027-01-01
First posted
2024-09-19
Last updated
2025-03-26

Source: ClinicalTrials.gov record NCT06597929. Inclusion in this directory is not an endorsement.