CClinicalTrials.gg
RecruitingNCT06474832Updated Sep 19, 2024

High Intensity Interval Training in Chronic Stroke

An interventional study of High-intensity interval training and Moderate intensity continuous training in Chronic Stroke, sponsored by National Yang Ming Chiao Tung University. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Stroke

Browse trials for

Keywords

  • High-intensity interval training
  • Cardiorespiratory fitness
  • Gait quality
  • Chronic Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 32 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    High-intensity interval training group

    The intervention is a 42-minute session and 3-sessions/week, totaling 8 weeks.

    Other: High-intensity interval training

  • Active comparator
    Moderate intensity continuous training group

    The intervention is a 45-minute session and 3-sessions/week, totaling 8 weeks.

    Other: Moderate intensity continuous training

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from baseline at 8 weeks

  2. 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%

    Time frame: Change from baseline at 8 weeks

  3. 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%

    Time frame: Change from baseline at 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Change from baseline at 8 weeks

  2. 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

    Time frame: Change from baseline at 8 weeks

  3. 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

    Time frame: Change from baseline at 8 weeks

  4. 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.

    Time frame: Change from baseline at 8 weeks

  5. 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.

    Time frame: Change from baseline at 8 weeks

  6. 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).

    Time frame: Change from baseline at 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
    Taipei, 112, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06474832
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
Yea-Ru Yang (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Jun 26, 2024
Start date
Jul 16, 2024
Primary completion
Jul 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion