The Feasibility and Effects of Recumbent Cycling-based High-intensity Interval Training on Functional Performances, Cognitive Function, and Quality of Life in Early Subacute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility aspects
研究概览
简要总结
Although High-intensity interval training (HIIT) exercise has emerged in recent years as a powerful time-efficient alternative to moderate-intensity continuous cardiovascular exercise training (MICT) to enhance neuroplasticity, motor, and cognitive functions, its feasibility remains to be determined early after stroke. Our study aims to investigate the feasibility of the HIIT program and its effects on functional abilities, cognitive function, and quality of life in early post-stroke.
详细描述
Study design, setting, and ethical considerations:
This study will be a prospective pre-post study that will be conducted at the university hospital of Parakou in Benin. The study protocol will be submitted to the ethics committee of Hasselt University in Belgium and the local biomedical ethics committee of the University of Parakou, Republic of Benin.
Interventions:
The experimental protocol will be preceded by 30 minutes of conventional physiotherapy, including neuromuscular interventions (balance training, postural awareness), musculoskeletal interventions (passive range of motion, stretching, strengthening), and lower-intensity overground walking. The conventional physiotherapy will be followed by 15 min of the rest period, then the experimental protocol consisting of a HIIT program on a recumbent cycle SOLE R92 (HIIT-REC) will be performed three times per week for six successive weeks.21 Training will be performed on non-consecutive days, thereby permitting recovery between sessions. The HIIT procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload at 50 rpm for weeks 1-2 and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (4 to 6 repetitions). The training intensity will progress similarly by 5% peak workload two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5.22 All sessions will be supervised and performed individually with verbal encouragement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
- •muscular weakness of the leg on the hemiplegic side defined as NIHSS-Item 6 score between 1 and 3;
- •Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
- •able to walk at least 5 meters independently with or without assistive devices and understand spoken instructions;
- •living in Parakou or the surrounding area and wishing to undergo the program at the hospital.
排除标准
- •Participants:
- •unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate;
- •cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy);
- •primary orthopedic conditions (fractures, active rheumatoid arthritis);
- •other neurological diseases such as (Parkinson's disease and Alzheimer's disease).
结局指标
主要结局
Feasibility aspects
时间窗: Up to 6 weeks
The feasibility aspects, include recruitment rates (eligible population / consented population x 100), program adherence (attended sessions / total number of sessions x 100), and the safety (percentage of participants who will experience adverse events)
The change in the credibility of the treatment and the expectations of the participants
时间窗: Week 1 and Week 6
The treatment credibility and participant expectancy for improvement will be assessed with the Credibility and Expectancy Questionnaire (CEQ). The CEQ includes six items assessing a cognitively based credibility factor and an affectively based expectancy factor
次要结局
- The 5-level EQ-5D version(Week 1 and Week 6)
- 6-min walk test(Week 1 and Week 6)
- 10 m walk test(Week 1 and Week 6)
- Mini-Mental Stage Examination(Week 1 and Week 6)
- Berg Balance Scale(Week 1 and Week 6)
- 5-Repetition Sit-To-Stand test(Week 1 and Week 6)
- modified Rankin Scale(Week 1 and Week 6)
研究者
Dominique Hansen
Full Professor of Rehabilitation/Exercise Physiology in Cardiometabolic Diseases
Hasselt University