Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

NCT ID: NCT04833400

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2023-08-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intelligent cardiopulmonary rehabilitation system (ICRS)

The ICRS is very likely to the conventional stationary biking, but with an algorithm that automatically controls the resistance of pedalling, considering the instant heart rate and cadence, to keep the heart rate within the targeted heart rate zone.

Group Type: EXPERIMENTAL

ICRS

Intervention Type: DEVICE

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

Traditional aerobic exercise training (TAET)

The TAET is performed with stationary biking, with intensity being set as subjective rating of perceived exertion at a "somewhat hard" to "hard" level. The resistance of pedaling is ad-justed by the user or physical therapist.

Group Type: ACTIVE_COMPARATOR

TAET

Intervention Type: DEVICE

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

Interventions

ICRS

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

Intervention Type: DEVICE

TAET

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WanFang Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Yen-Nung Lin, MD, MS

Role: primary

semitune@gmail.com

0970746879

Other Identifiers

N202010012

Identifier Type: -

Identifier Source: org_study_id