Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833400
• Other study ID #: N202010012
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2022
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• ICRS
Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
• TAET
Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative VO2-peak (mL/kg/min)	oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.	4 weeks
Secondary	6-min walk test	The 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.	4 weeks
Secondary	absolute VO2-peak (mL/min)	oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.	4 weeks
Secondary	workload-peak (Watt)	The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.	4 weeks