Stroke
Conditions
Brief summary
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.
Interventions
BEHAVIORALHigh-intensity Interval Training
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
BEHAVIORALModerate-Intensity Continuous Training
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
BEHAVIORALStretching
There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and postmenopausal women aged 50-80 years * 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography * Able to walk 10 meters independently with or without a walking aid * Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)
Exclusion criteria
* Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months * Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months * Participation in ongoing stroke rehabilitation services or structured exercise programme * Cognitive or communication issues that could limit the ability to follow instructions * Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Muscle Power at Week 12 | Baseline and 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Muscle Power at Week 24 | Baseline and 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) |
| Change from Baseline in Muscle Strength (Nm) at Week 12 | Baseline and Week 12 | 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) |
| Change from Baseline in Muscle Strength (Nm) at Week 24 | Baseline and 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) |
| Change from Baseline in Muscle Strength (kg) at Week 12 | Baseline and Week 12 | Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 12 Level - Baseline Level) |
| Change from Baseline in Muscle Strength (kg) at Week 24 | Baseline and Week 24 | Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 24 Level - Baseline Level) |
| Change from Baseline in Body Composition (kg) at Week 12 | Baseline and 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) |
| Change from Baseline in Body Composition (kg) at Week 24 | Baseline and 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) |
| Change from Baseline in Body Composition (%) at Week 12 | Baseline and Week 12 | Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 12 Level - Baseline Level) |
| Change from Baseline in Body Composition (%) at Week 24 | Baseline and Week 24 | Body fat percentage (%) will be measured using bioelectrical impedance analysis (BIA). Change=(Week 24 Level - Baseline Level) |
| Change from Baseline in Biomarkers at Week 12 | Baseline and 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) |
| Change from Baseline in Biomarkers at Week 6 | Baseline and 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) |
| Change from Baseline in Motor Function at Week 12 | Baseline and 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) |
| Change from Baseline in Motor Function at Week 24 | Baseline and 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) |
| Change from Baseline in Motor Function (meters) at Week 12 | Baseline and 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) |
| Change from Baseline in Motor Function (meters) at Week 24 | Baseline and 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) |
| Change from Baseline in Balance Function at Week 12 | Baseline and 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) |
| Change from Baseline in Balance Function at Week 24 | Baseline and 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) |
| Change from Baseline in Cardiopulmonary Response at Week 12 | Baseline and 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) |
| Change from Baseline in Cardiopulmonary Response at Week 24 | Baseline and 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) |
| Change from Baseline in Psychosocial Responses at Week 12 | Baseline and 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) |
| Change from Baseline in Psychosocial Responses at Week 24 | Baseline and 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) |
Countries
Hong Kong
Contacts
CONTACTChen Xu, PhD student
CONTACTMeizhen Huang, PhD
Outcome results
None listed