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Clinical Trials/NCT06474832
NCT06474832
Not yet recruiting
Not Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country32 target enrollmentJuly 1, 2024
ConditionsChronic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
National Yang Ming Chiao Tung University
Enrollment
32
Locations
1
Primary Endpoint
Gait symmetry index (SI)
Status
Not yet recruiting
Last Updated
last year

Overview

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. 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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

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

Outcomes

Primary Outcomes

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%

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%

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

Secondary Outcomes

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

Study Sites (1)

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