High Intensity Interval Training in Chronic Stroke
NCT Number: NCT06474832
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Stroke
Interventions: OTHER: High-intensity interval training|OTHER: Moderate intensity continuous training
Sponsor: National Yang Ming Chiao Tung University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-31
Locations: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, 112, Taiwan

Summary:
Both gait and cardiovascular dysfunction are primary factors limiting community ambulation for stroke individuals. Increased gait variability and asymmetry contributes to a higher risk of falls, leading to reduced physical activity, decreased cardiorespiratory endurance, and increased walking economy and sympathetic nervous system activity, thereby potentially triggering secondary strokes. Previous studies have primarily focused on the significant improvements in walking endurance and speed with high-intensity interval training (HIIT) on a treadmill, leaving a gap in understanding the effects of HIIT on oxygen uptake efficiency slope (OUES) and gait quality for stroke individuals using a stationary bicycle ergometer. Therefore, the purpose of this study is to investigate the effects of HIIT using a stationary bicycle ergometer on improving cardiorespiratory fitness and gait quality in individuals with chronic stroke.

Primary Outcome Measures: Oxygen uptake efficiency slope (OUES): cardiovascular fitness, Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.

OUES = Oxygen uptake / Log10 \* Minute ventilation, Change from baseline at 8 weeks|Gait variability, Using GAITRite system to measure coefficient of variation. During the assessment, participants will be asked to walk three times. The mean and standard deviation will be used to calculate the coefficient of variation (CV).

CV = standard deviation / mean \* 100%, Change from baseline at 8 weeks|Gait symmetry index (SI), Use the GAITRite system to assess the symmetry of spatial and temporal gait parameters. During the assessment, participants will be asked to walk three times. Calculate the symmetry index using the mean.

SI = (affected side - unaffected side) / (1/2 \* (affected side + unaffected side)) \* 100%, Change from baseline at 8 weeks
Secondary Outcome Measures: Peak oxygen consumption (VO2peak): cardiovascular fitness, Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort., Change from baseline at 8 weeks|Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness, Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.

VE/VCO2 slope = minute ventilation / carbon dioxide production, Change from baseline at 8 weeks|Heart rate recovery (HRR): cardiovascular fitness-, Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort.

HRR = peak heart rate - heart rate after one minute, Change from baseline at 8 weeks|Blood pressure (BP): cardiovascular fitness, Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort., Change from baseline at 8 weeks|6 minutes walking distance (6MWD): cardiovascular fitness, For the 6MWD, participants are asked to walk as fast as possible along a 30-meter corridor. During the test, heart rate and blood oxygen saturation level are continuously monitored. Record heart rate, blood pressure, blood oxygen saturation level, RPE, and total walking distance before and after the test., Change from baseline at 8 weeks|International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form), The IPAQ is a self-reported instrument assesses the time spent in the past 7 days on activities including work, housework, gardening/balcony work, commuting, leisure, and exercise. Total time spent per week is multiplied by the metabolic equivalent (MET) and summed to present the total MET-minutes per week. Physical activity intensity is classified into walking (3.3 METs), moderate (4.0 METs), and vigorous (8.0 METs)., Change from baseline at 8 weeks