Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: ICRS; Device: TAET

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • WanFang Hospital
    • Contact: Yen-Nung Lin, MD, MS; Phone Number: 0970746879; Email: semitune@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: ICRS; Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
Active Comparator: 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.	Device: TAET; Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 16, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: aerobic training; cardiorespiratory fitness; cardiopulmonary exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: N202010012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No