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

U

Universitat Internacional de Catalunya

Status

Not yet enrolling

Conditions

Physical Inactivity
Stroke

Treatments

Other: Moderate-vigorous physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT06597929
M-VILPA-stroke

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

57+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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).

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Usual care plus the MV-ILPA and education program.
Experimental group
Description:
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.
Treatment:
Other: Moderate-vigorous physical activity
Usual care
Active Comparator group
Description:
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.
Treatment:
Other: Moderate-vigorous physical activity

Trial contacts and locations

0

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Central trial contact

David Blanco de Tena-Dávila, PhD; Marcio Vinicius Fagundes Donadio, PhD

Data sourced from clinicaltrials.gov

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