NCT04833400

Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taipei Medical University WanFang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	ICRS	Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
DEVICE	TAET	Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.

Timeline

• Start date: 2022-01-25
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2021-04-06
• Last updated: 2022-07-20

Locations

1 site across 1 country: Taiwan