High Intensity Interval Training in Chronic Stroke

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Other: High-intensity interval training; Other: Moderate intensity continuous training

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yea-Ru Yang, PhD; Phone Number: +886-2-2826-7279; Email: yryang@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Training on a stationary bike, 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.
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; Training on a stationary bike, including a warm-up and cool-down at 30% HRR for 5 minutes each. Perform continuous exercise at 59% HRR for 35 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline at 8 weeks
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%	Change from baseline at 8 weeks
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%	Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline at 8 weeks
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	Change from baseline at 8 weeks
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	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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).	Change from baseline at 8 weeks

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: High-intensity interval training; Cardiorespiratory fitness; Chronic Stroke; Gait quality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NYCU113060AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No