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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The amount of moderate-vigorous intense physical activity (PA).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •other neurological diseases (e.g. Parkinson disease) or severe lower limb injuries.
研究组 & 干预措施
Usual care plus the MV-ILPA and education program.
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.
干预措施: Moderate-vigorous physical activity (Other)
Usual care
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.
干预措施: Moderate-vigorous physical activity (Other)
结局指标
主要结局
The amount of moderate-vigorous intense physical activity (PA).
时间窗: 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.
The amount of moderate-vigorous intense physical activity (PA).
时间窗: From enrollment to the end of treatment at 12 weeks (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.
The amount of moderate-vigorous intense physical activity (PA).
时间窗: 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.
次要结局
- Lower limb peak power(Day 0 and Month 3)
- Balance(Day 0 and Month 3)
- Gait speed(Day 0 and Month 3)
- Fatigue(Day 0 and Month 3)
- Quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.(Day 0 and Month 3)
- Degree of disability(Day 0 and Month 3)
- Stroke recurrence(Day 0 and Month 3)
- Death(Day 0 and Month 3)
- Falls(Day 0 and Month 3)
- Falls(Day 0 and Month 3 From enrollment to the end of treatment at 12 weeks)
- Lower limb mean power(Day 0 and Month 3)
- Leg strength and endurance by 30 seconds sit to stand test(From enrollment to the end of treatment at 12 weeks)
- Lower limb mean power(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Balance(Day 0 T0, at 12-week T1 and 24-week follow-up)
- Gait speed (comfortable and fast pace)(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Fatigue(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Degree of disability(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Stroke recurrence(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Death(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Falls(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Leg strength and endurance by 30 seconds sit to stand test(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
- Basic Activities of daily living (Fundamental Self-Care)(Day 0 T0, at 12-week T1 and 24-week follow-up T2)
研究者
Rosa Cabanas Valdés
PhD
Universitat Internacional de Catalunya