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High Intensity Interval Training in Chronic Stroke

Not Applicable
Not yet recruiting
Conditions
Chronic Stroke
Registration Number
NCT06474832
Lead Sponsor
National Yang Ming Chiao Tung University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Gait symmetry index (SI)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 variabilityChange 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 fitnessChange 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 Outcome Measures
NameTimeMethod
Heart rate recovery (HRR): cardiovascular fitness-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

6 minutes walking distance (6MWD): cardiovascular fitnessChange 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.

Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitnessChange 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

Peak oxygen consumption (VO2peak): cardiovascular fitnessChange 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.

Blood pressure (BP): cardiovascular fitnessChange 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.

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

Trial Locations

Locations (1)

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

🇨🇳

Taipei, Taiwan

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
🇨🇳Taipei, Taiwan
Yea-Ru Yang, PhD
Contact
+886-2-2826-7279
yryang@nycu.edu.tw

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