Effects of an Integrated Home-Based Physical Fitness and Self-Management Programme (I-STROKEFIT+) on Physical Fitness Among Community-Dwelling Stroke Survivors: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The 6-Minute Walk Test
研究概览
简要总结
This pilot randomized controlled study will evaluate whether a 12-week integrated home-based physical fitness and self-management programme (i-StrokeFit+) can improve physical fitness and physical activity among community-dwelling stroke survivors. The programme combines aerobic exercise, strengthening exercises, stretching, and self-management strategies. The study hypothesizes that participants receiving i-StrokeFit+ will demonstrate greater improvements in physical fitness and physical activity compared with participants receiving stroke education and simple stretching exercises.
详细描述
This pilot randomised controlled study evaluated the effects of an integrated home-based physical fitness and self-management programme (i-StrokeFit+) among community-dwelling stroke survivors. The study was conducted to determine whether a structured home-based programme combining physical fitness training with self-management support could improve physical fitness and physical activity compared with an educational control programme.
Participants who met the study requirements were screened, provided informed consent, and underwent baseline assessment before being randomly allocated to either the i-StrokeFit+ intervention group or the control group. The intervention commenced with a 2-week supervised adaptation phase to familiarise participants with the exercise programme, ensure appropriate exercise technique, and support safe progression before transitioning to home-based training.
Following the adaptation phase, participants in the i-StrokeFit+ group continued a structured 12-week home-based exercise programme incorporating aerobic exercise, resistance exercise, mixed aerobic and resistance training, and self-management support. Exercise training was progressively adjusted according to frequency, intensity, duration, sets, and repetitions. Brisk walking was used for aerobic training, while resistance bands and bodyweight exercises were used for resistance training. Participants were provided with educational and self-management materials, including guidance on stroke management, nutrition, physical activity, lifestyle, exercise scheduling, and exercise monitoring. Exercise adherence was supported through an exercise handbook, checklist or diary, and activity monitoring devices.
Participants in the control group received stroke education and simple stretching exercises. The control programme did not include a structured progressive physical fitness training programme.
Assessments were conducted at baseline, Week 6, and Week 12. The study used a single-blinded assessment approach, with outcome assessments conducted at the participating study sites. The study was designed as a pilot randomised controlled trial to evaluate the preliminary effects of the i-StrokeFit+ programme and to provide information for future research involving a larger sample.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who had been diagnosed with stroke more than 6 months since the accident occurred.
- •The age ranged from 20 to 59 years.
- •Able to ambulate with or without an assistive device with a score of (Functional Ambulatory Category ≥3).
- •Presented with the National Institutes of Health Stroke Scale (NIHSS) score 5-14 (mild to moderately severe)
- •Participants who have a sedentary lifestyle according to the Stroke Physical Activity Questionnaire
- •Participants presented with normal cognitive function
- •Able to understand and speak the Malay or English language.
排除标准
- •Participants presented with aphasia
- •Participants with uncontrolled blood pressure
- •Participants who have contraindications towards submaximal exercise testing, such as active inflammatory heart disease or acute myocardial infarction.
研究组 & 干预措施
I-STROKEFIT+
Participants received the i-StrokeFit+ programme, an integrated physical fitness and self-management intervention. The programme included aerobic exercise, resistance exercise, mixed aerobic and resistance training, and self-management education. Participants first completed a 2-week supervised adaptation phase before continuing the structured exercise programme in a home-based setting. Exercise was progressively adjusted according to frequency, intensity, duration, sets, and repetitions. Participants also received materials to support exercise scheduling, monitoring, and adherence.
干预措施: Physical fitness and Self-Management (Other)
Control Group
Participants received a stroke education programme covering stroke-related information, including symptoms, risk factors, pathophysiology, and management. Participants were also provided with simple stretching exercises. The control programme did not include a structured progressive physical fitness training programme, and the stretching exercises were unstructured and unsupervised
干预措施: Patient Education (Other)
结局指标
主要结局
The 6-Minute Walk Test
时间窗: Baseline, 6 Week and 12 Week
The 6-Minute Walk Test (6MWT) is a functional walking test used to assess cardiorespiratory fitness and walking endurance. Participants are instructed to walk as far as possible along a designated walking course for 6 minutes, and the total distance walked is recorded in metres.
Handheld Dyanamometer Muscle Strength
时间窗: Baseline, 6 Week and 12 Week
The handheld dynamometer is used to assess isometric muscle strength. Muscle strength is measured on the affected side for the biceps, triceps, quadriceps, and hamstrings, with the maximum force recorded in kilograms-force (kgf).
30 Seconds Chair Stand Test
时间窗: Baseline, 6 Week and 12 Week
The 30-Second Chair Stand Test (30-SCST) is a functional test used to assess lower-limb muscle strength and endurance. Participants are instructed to stand up from a chair and sit down as many times as possible within 30 seconds. The total number of completed repetitions is recorded.
次要结局
- 10 Meter Walk Test(Baseline, 6 Week and 12 Week)
- Stroke Physical Activity Questionnaire(Baseline, 6 Week and 12 Week)
- Stroke Specific Quality of Life(Baseline, 6 Week and 12 Week)
研究者
Mohamad Rasydan Bin Ramlan
MR
Universiti Teknologi Mara