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NCT Number: NCT06474832

High Intensity Interval Training in Chronic Stroke

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.

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Key information

Conditions

Chronic Stroke

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Yea-Ru Yang, PhD

CONTACT

[email protected]

+886-2-2826-7279

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High-intensity interval training

Other

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.

Moderate Intensity Continuous Training

Other

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.

Primary outcomes

  1. Oxygen uptake efficiency slope (OUES): cardiovascular fitness

    Time frame: Change from baseline at 8 weeks

    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

  2. Gait variability

    Time frame: Change from baseline at 8 weeks

    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%

  3. Gait symmetry index (SI)

    Time frame: Change from baseline at 8 weeks

    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%

Secondary outcomes

  1. Peak oxygen consumption (VO2peak): cardiovascular fitness

    Time frame: Change from baseline at 8 weeks

    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.

  2. Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness

    Time frame: Change from baseline at 8 weeks

    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

  3. Heart rate recovery (HRR): cardiovascular fitness-

    Time frame: Change from baseline at 8 weeks

    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

  4. Blood pressure (BP): cardiovascular fitness

    Time frame: Change from baseline at 8 weeks

    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.

  5. 6 minutes walking distance (6MWD): cardiovascular fitness

    Time frame: Change from baseline at 8 weeks

    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.

  6. International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)

    Time frame: Change from baseline at 8 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yea-Ru Yang, PhD

CONTACT

[email protected]

+886-2-2826-7279

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Sep 19, 2024

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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