Moderate-vigorous Intermittent Physical Activity (M-VILPA) in Stroke
- Conditions
- Physical InactivityStroke
- Interventions
- Other: Moderate-vigorous physical activity
- Registration Number
- NCT06597929
- Lead Sponsor
- Universitat Internacional de Catalunya
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- adults aged ≥57 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).
• other neurological diseases (e.g. Parkinson disease) or severe lower limb injuries.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care plus the MV-ILPA and education program. 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. Usual care Moderate-vigorous physical activity 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.
- Primary Outcome Measures
Name Time Method The amount of moderate-vigorous intense physical activity (PA). The measurements will be performed during the week before Day 0 and Month 3. All participants will be monitored with a 3-axial accelerometer (strapped on the thigh) for 7 days to record their total daily movement counts and the minutes of moderate-to-vigorous-intensity PA.
- Secondary Outcome Measures
Name Time Method Lower limb peak power 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. Three attempts were given interspersed by 30-60 s. The attempt with the highest peak power was selected for further analyses. It is measured in Watts.Higher peak power means better outcome.
Balance Day 0 and Month 3 It will be assess by Berg Balance Scale, 0-56 points higher scores means better outcome
Gait speed Day 0 and Month 3 4-metre walk test, less time mean better outcome
Fatigue 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.
Quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. 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.
Degree of disability Day 0 and Month 3 Modified-Rankin Scale, single-item global outcomes rating scale, from 0 to 5. Higher score means worse outcome.
Stroke recurrence Day 0 and Month 3 yes/no, date
Death Day 0 and Month 3 yes/no, date
Falls Day 0 and Month 3 yes/no, date