High Intensity Interval Training in Chronic Stroke

NCT06474832 | Recruiting

• 1 other identifier: NYCU113060AF
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Stroke

Keywords

High-intensity interval training; Cardiorespiratory fitness; Gait quality; Chronic Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Peak oxygen consumption (VO2peak): cardiovascular fitness

  Change from baseline at 8 weeks

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

  Change from baseline at 8 weeks

• Heart rate recovery (HRR): cardiovascular fitness-

  Change from baseline at 8 weeks

• Blood pressure (BP): cardiovascular fitness

  Change from baseline at 8 weeks

• 6 minutes walking distance (6MWD): cardiovascular fitness

  Change from baseline at 8 weeks

Study Arms (2)

High-intensity interval training group

EXPERIMENTAL

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

Other: High-intensity interval training

Moderate intensity continuous training group

ACTIVE COMPARATOR

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

Other: Moderate intensity continuous training

Interventions

High-intensity interval training OTHER

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.

High-intensity interval training group

Moderate intensity continuous training OTHER

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.

Moderate intensity continuous training group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

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

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

+886-2-2826-7279; yryang@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 26, 2024
• Study Start: July 16, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TW (1)