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Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors.
Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors.
Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions.
Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, and psychosocial response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity interval training | Experimental | The HIIT session will consist of a 3-minute warm-up, a 20-minute main exercise, and a 2-minute cool-down. The main exercise for HIIT will include ten high-intensity intervals, interspersed with ten low-intensity intervals. |
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| Moderate-intensity continuous training | Active Comparator | The MICT session will consist of a 3-minute warm-up, a main exercise that approximately matches the total workload of the HIIT session (lasting about 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain below the vigorous level by progressively adjusting the workload throughout the intervention period. |
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| Stretching | Active Comparator | The stretching group will receive 25 minutes of whole-body stretching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity Interval Training | Behavioral | There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Muscle Power at Week 12 | Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level) | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Muscle Power at Week 24 | Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level) | Baseline and Week 24 |
| Change from Baseline in Muscle Strength (Nm) at Week 12 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Xu, PhD student | Contact | 00000000 | rschen.xu@connect.polyu.hk | |
| Meizhen Huang, PhD | Contact | 00000000 | mei-zhen.huang@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Kowloon | Hong Kong |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| Moderate-Intensity Continuous Training | Behavioral | There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. |
|
| Stretching | Behavioral | There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions. |
|
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level) |
| Baseline and Week 12 |
| Change from Baseline in Muscle Strength (Nm) at Week 24 | Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level) | Baseline and Week 24 |
| Change from Baseline in Muscle Strength (kg) at Week 12 | Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 12 Level - Baseline Level) | Baseline and Week 12 |
| Change from Baseline in Muscle Strength (kg) at Week 24 | Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 24 Level - Baseline Level) | Baseline and Week 24 |
| Change from Baseline in Body Composition (kg) at Week 12 | Whole-body skeletal muscle mass (kg), bone mineral content (kg), fat mass (kg), and segmental lean mass (kg) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 12 Level - Baseline Level) | Baseline and Week 12 |
| Change from Baseline in Body Composition (kg) at Week 24 | Whole-body skeletal muscle mass (kg), bone mineral content (kg), fat mass (kg), and segmental lean mass (kg) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 24 Level - Baseline Level) | Baseline and Week 24 |
| Change from Baseline in Body Composition (%) at Week 12 | Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 12 Level - Baseline Level) | Baseline and Week 12 |
| Change from Baseline in Body Composition (%) at Week 24 | Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 24 Level - Baseline Level) | Baseline and Week 24 |
| Change from Baseline in Biomarkers at Week 12 | Volume-corrected serum concentration (mg/dL) of myokines, bone markers, pro-inflammatory markers, biomarkers of oxidative stress will be measured using enzyme-linked immunosorbent assay (ELISA) kits. Change=(Week 12 Level - Baseline Level) | Baseline and Week 12 |
| Change from Baseline in Biomarkers at Week 6 | Volume-corrected serum concentration (mg/dL) of myokines, bone markers, pro-inflammatory markers, biomarkers of oxidative stress will be measured using enzyme-linked immunosorbent assay (ELISA) kits. Change=(Week 6 Level - Baseline Level) | Baseline and Week 6 |
| Change from Baseline in Motor Function at Week 12 | Fugl-Meyer Motor Assessment (FMA) will be used to assess the degree of motor recovery of the hemiparetic upper (range: 0-66) and lower limbs (range: 0-34). Higher scores are indicative of better motor recovery. Short Physical Performance Battery (SPPB) will be used to assess the physical performance, including 5-times sit-to-stand, balance tests (side-by-side-stand, semi-tandem stand, and tandem stand), and gait speed. Change=(Week 12 Score- Baseline Score) | Baseline and Week 12 |
| Change from Baseline in Motor Function at Week 24 | Fugl-Meyer Motor Assessment (FMA) will be used to assess the degree of motor recovery of the hemiparetic upper (range: 0-66) and lower limbs (range: 0-34). Higher scores are indicative of better motor recovery. Short Physical Performance Battery (SPPB) will be used to assess the physical performance, including 5-times sit-to-stand, balance tests (side-by-side-stand, semi-tandem stand, and tandem stand), and gait speed. Change=(Week 24 Score- Baseline Score) | Baseline and Week 24 |
| Change from Baseline in Motor Function (meters) at Week 12 | The 6-minute walk test (6MWT) will be used to measure walking endurance and capacity. The total distance walked in meters during the test will be recorded. Change=(Week 12 distance - Baseline distance) | Baseline and Week 12 |
| Change from Baseline in Motor Function (meters) at Week 24 | The 6-minute walk test (6MWT) will be used to measure walking endurance and capacity. The total distance walked in meters during the test will be recorded. Change=(Week 24 distance - Baseline distance) | Baseline and Week 24 |
| Change from Baseline in Balance Function at Week 12 | Balance performance will be assessed using the Mini Balance Evaluation Systems Test (range: 0-28). Higher scores are indicative of better balance performance. Fear of falling will be assessed using the Chinese version of the Activities-Specific Balance Confidence Scale (range: 0-100). Higher scores are indicative of higher balance confidence. Change=(Week 12 Score- Baseline Score) | Baseline and Week 12 |
| Change from Baseline in Balance Function at Week 24 | Balance performance will be assessed using the Mini Balance Evaluation Systems Test (range: 0-28). Higher scores are indicative of better balance performance. Fear of falling will be assessed using the Chinese version of the Activities-Specific Balance Confidence Scale (range: 0-100). Higher scores are indicative of higher balance confidence. Change=(Week 24 Score- Baseline Score) | Baseline and Week 24 |
| Change from Baseline in Cardiopulmonary Response at Week 12 | Peak oxygen uptake (VO2peak) will be measured using a graded exercise test (GXT). The GXT will be conducted following a well-validated protocol that on a whole-body recumbent stepper to assess cardiopulmonary function in stroke patients. Change=(Week 12 VO2peak - Baseline VO2peak) | Baseline and Week 12 |
| Change from Baseline in Cardiopulmonary Response at Week 24 | Peak oxygen uptake (VO2peak) will be measured using a graded exercise test (GXT). The GXT will be conducted following a well-validated protocol that on a whole-body recumbent stepper to assess cardiopulmonary function in stroke patients. Change=(Week 24 VO2peak - Baseline VO2peak) | Baseline and Week 24 |
| Change from Baseline in Psychosocial Responses at Week 12 | Post-stroke fatigue will be assessed using the Fatigue Severity Scale (range: 1-7). Higher scores are indicative of more severe fatigue. Health-related quality of life will be assessed using 12-Item Short Form Health Survey (range: 0-100). Higher scores are indicative of better quality of life. Exercise enjoyment will be assessed by the Physical Activity Enjoyment Scale and Behavioural Regulation Exercise Questionnaire-3 (range: 0-400). Higher scores indicate a higher exercise enjoyment level. Motivation for exercise will be assessed using the Behavioural Regulation Exercise Questionnaire-3 (range: 0-96). Higher scores indicate more motivation to exercise. A semi-structured interview will be additionally conducted at the end of the intervention (week 12) to explore the experiences of HIIT in stroke patients. Change=(Week 12 Score - Baseline Score) | Baseline and Week 12 |
| Change from Baseline in Psychosocial Responses at Week 24 | Post-stroke fatigue will be assessed using the Fatigue Severity Scale (range: 1-7). Higher scores are indicative of more severe fatigue. Health-related quality of life will be assessed using 12-Item Short Form Health Survey (range: 0-100). Higher scores are indicative of better quality of life. Exercise enjoyment will be assessed by the Physical Activity Enjoyment Scale and Behavioural Regulation Exercise Questionnaire-3 (range: 0-400). Higher scores indicate a higher exercise enjoyment level. Motivation for exercise will be assessed using the Behavioural Regulation Exercise Questionnaire-3 (range: 0-96). Higher scores indicate more motivation to exercise. A semi-structured interview will be additionally conducted at the end of the intervention (week 12) to explore the experiences of HIIT in stroke patients. Change=(Week 24 Score - Baseline Score) | Baseline and Week 24 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |