Clinical trial NCT04833400: Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke
Official title: Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: cardiopulmonary exercise
cardiorespiratory fitness
aerobic training
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke.

Detailed description: Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity.

To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity.

A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%\~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Aged 20-75 y/o
* Healthy people
* Chronic stroke \> 6 months
* Able to walk independently \> 6 minutes with or without orthosis
* Able to use stationary bike
* MRS(Modified Rankin Scale) ranged 1 to 3

Exclusion Criteria:

* Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users)
* With any reason that the patient is not suitable to undergo aerobic training
* Patients who are unable to do cycling due to musculoskeletal problems
* Patients who can not follow the instruction of trainers due to cognitive or emotional-problems.
* Patients whose medical condition is not unstable.

Primary outcomes:
measure: relative VO2-peak (mL/kg/min)
timeFrame: 4 weeks
Secondary outcomes:
measure: 6-min walk test
timeFrame: 4 weeks
measure: absolute VO2-peak (mL/min)
timeFrame: 4 weeks
measure: workload-peak (Watt)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
References: