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Recruiting NCT06474832

High Intensity Interval Training in Chronic Stroke

No phase Interventional Chronic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-intensity interval training, Moderate intensity continuous training.
Who it may be relevant to
Registry conditions: Chronic Stroke. Basic parameters: 18 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other High-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.
  • Other Moderate 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.

Primary outcome measures

  • Oxygen uptake efficiency slope (OUES): cardiovascular fitness [Time frame: Change from baseline at 8 weeks]
  • Gait variability [Time frame: Change from baseline at 8 weeks]
  • Gait symmetry index (SI) [Time frame: Change from baseline at 8 weeks]
Secondary outcome measures (6)
  • Peak oxygen consumption (VO2peak): cardiovascular fitness [Time frame: Change from baseline at 8 weeks]
  • Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness [Time frame: Change from baseline at 8 weeks]
  • Heart rate recovery (HRR): cardiovascular fitness- [Time frame: Change from baseline at 8 weeks]
  • Blood pressure (BP): cardiovascular fitness [Time frame: Change from baseline at 8 weeks]
  • 6 minutes walking distance (6MWD): cardiovascular fitness [Time frame: Change from baseline at 8 weeks]
  • International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form) [Time frame: Change from baseline at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung Uni — Taipei

Identifiers

NCT: NCT06474832 · NYCU113060AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗