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High Intensity Interval Training in Chronic Stroke

Effects of High Intensity Interval Training on Cardiorespiratory Fitness and Gait Quality in People With Chronic Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06474832
Enrollment
32
Registered
2024-06-26
Start date
2024-07-16
Completion date
2025-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke

Keywords

High-intensity interval training, Cardiorespiratory fitness, Gait quality, Chronic Stroke

Brief 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 with exergaming. Therefore, this study aims to investigate the effects of HIIT using a stationary bicycle ergometer on improving cardiorespiratory fitness and gait quality in individuals with chronic stroke.

Interventions

OTHERHigh-intensity interval training

Training on a stationary bike and integrated with exergame (Jbike, JACFIT, USA), the exercise games connect to a map in the app through sensors, allowing players from different countries to ride together and complete the map, thus increasing the diversity of the training, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform HIIT with 5 intervals at 80% heart rate reserve (HRR), each interval lasting 4 minutes, with 3-minute intervals at 40% HRR between each interval.

OTHERModerate intensity continuous training

Training on a stationary bike and integrated with exergame (Jbike, JACFIT, USA), the exercise games connect to a map in the app through sensors, allowing players from different countries to ride together and complete the map, thus increasing the diversity of the training, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform continuous exercise at 59% HRR for 35 minutes.

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Aged 18-69 years * At least 6 months post-stroke * Functional Ambulation Category (FAC) ≥ 3 * Mini-Mental State Examination (MMSE) ≥ 24 * Able to walk 10 meters overground with or without assistive devices

Exclusion criteria

* Unstable cardiopulmonary conditions within the last 3 months * Other chronic neurological disorders * Contraindications to exercise as recommended by the American College of Sports Medicine (ACSM) * Severe lower limb spasticity (Modified Ashworth Scale \> 2 points) * Implanted pacemaker or cardioverter defibrillator

Design outcomes

Primary

MeasureTime frameDescription
Oxygen uptake efficiency slope (OUES): cardiovascular fitnessChange from baseline at 8 weeksPerform 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
Gait variabilityChange from baseline at 8 weeksUsing 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%
Gait symmetry index (SI)Change from baseline at 8 weeksUse 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%

Secondary

MeasureTime frameDescription
Blood pressure (BP): cardiovascular fitnessChange from baseline at 8 weeksPerform 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.
Peak oxygen consumption (VO2peak): cardiovascular fitnessChange from baseline at 8 weeksPerform 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.
International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)Change from baseline at 8 weeksThe 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).
6 minutes walking distance (6MWD): cardiovascular fitnessChange from baseline at 8 weeksFor 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.
Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitnessChange from baseline at 8 weeksPerform 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
Heart rate recovery (HRR): cardiovascular fitness-Change from baseline at 8 weeksPerform 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

Countries

Taiwan

Contacts

Primary ContactYea-Ru Yang, PhD
yryang@nycu.edu.tw+886-2-2826-7279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026