Clinical trial NCT06474832: High Intensity Interval Training in Chronic Stroke
Official title: Effects of High Intensity Interval Training on Cardiorespiratory Fitness and Gait Quality in People With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: High-intensity interval training
Cardiorespiratory fitness
Gait quality
Chronic Stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Oxygen uptake efficiency slope (OUES): cardiovascular fitness
timeFrame: Change from baseline at 8 weeks
measure: Gait variability
timeFrame: Change from baseline at 8 weeks
measure: Gait symmetry index (SI)
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Peak oxygen consumption (VO2peak): cardiovascular fitness
timeFrame: Change from baseline at 8 weeks
measure: Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness
timeFrame: Change from baseline at 8 weeks
measure: Heart rate recovery (HRR): cardiovascular fitness-
timeFrame: Change from baseline at 8 weeks
measure: Blood pressure (BP): cardiovascular fitness
timeFrame: Change from baseline at 8 weeks
measure: 6 minutes walking distance (6MWD): cardiovascular fitness
timeFrame: Change from baseline at 8 weeks
measure: International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)
timeFrame: Change from baseline at 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References: