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NCT Number: NCT07824570

Effects of I-STROKEFIT+ on Physical Fitness Among Community-Dwelling Stroke Survivors: A Pilot RCT

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.

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Key information

Conditions

Stroke Brain Diseases CVA Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident (CVA) Cerebrovascular Disorders Chronic Stroke Patient Community Dwelling Nervous System Diseases Stroke (6 Months or More After Onset) Vascular Diseases

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UiTM Kampus Puncak Alam

Shah Alam, Selangor, 42300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Physical fitness and Self-Management

Other

A structured home-based exercise and self-management programme designed to improve physical fitness among community-dwelling stroke survivors. The programme included aerobic exercise, resistance exercise, mixed training, and self-management education, following a 2-week supervised adaptation phase before home-based training.

Patient Education

Other

An educational programme providing information about stroke, including its symptoms, risk factors, pathophysiology, and management, together with simple stretching exercises. The stretching exercises were unstructured and unsupervised.

Primary outcomes

  1. The 6-Minute Walk Test

    Time frame: 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.

  2. Handheld Dyanamometer Muscle Strength

    Time frame: 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).

  3. 30 Seconds Chair Stand Test

    Time frame: 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.

Secondary outcomes

  1. 10 Meter Walk Test

    Time frame: Baseline, 6 Week and 12 Week

    The 10-Meter Walk Test (10MWT) is a functional walking test used to assess walking performance. Participants are instructed to walk at their comfortable walking speed along a 10-meter walkway, and their walking speed is calculated and recorded in metres per second (m/s).

  2. Stroke Physical Activity Questionnaire

    Time frame: Baseline, 6 Week and 12 Week

    Stroke Physical Activity Questionnaire (SPAQ): Total time spent participating in physical activities during the previous 7 days, reported as minutes per week. The questionnaire assesses low, moderate, and vigorous physical activities. Scores are expressed as minutes per week, with higher values indicating greater physical activity

  3. Stroke Specific Quality of Life

    Time frame: Baseline, 6 Week and 12 Week

    Stroke-Specific Quality of Life Scale (SS-QOL): A 49-item, stroke-specific measure of health-related quality of life across 12 domains. Total scores range from 49 to 245, with higher scores indicating better quality of life and functioning.

Sponsors and collaborators

Lead sponsor

Universiti Teknologi Mara

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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