An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

Not Applicable

• Conditions: Lifestyle, Sedentary
• Interventions: Device: Intelligent cardiopulmonary rehabilitation system (ICRS)

• Registration Number: NCT04662307
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

Contemporary cardiopulmonary rehabilitation programs often utilize cycling ergometer, involving one-on-one heart rate monitoring by physiotherapists to ensure that patients reach the target training intensity during training sessions. However, the process is frequently described as monotonous and boring, resulting in early fatigue of therapists and patients as well as poor compliance, leading to undertraining and suboptimal outcomes.

This study aims to test the feasibility of the "Intelligent Cardiopulmonary Training System (ICRS)" and a novel indicator of measuring the adherence to training intensity. The ICRS was developed with the idea to provide machine-based supervision on the user's heart rate during training. It provides moderate-intensity continuous training with a cycling ergometer. This system automatically adjusts the paddling resistance according to the user's real-time heart rate, and helps to improve the user's adherence to pre-determined training intensity without trainer's watch. The automation of intensity adjustment has its potential for conditions in which supervision is not feasible.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-10
• Study Start: 2020-12-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-12-15
• Study Completion: 2023-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Sedentary healthy people

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
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intelligent cardiopulmonary rehabilitation system (ICRS)	Intelligent cardiopulmonary rehabilitation system (ICRS)	The intelligent cardiopulmonary rehabilitation system is designed to improve the user's adherence to pre-determined training intensity. The training intensity is pre-determined using the 60%-80% heart rate reserve which is obtained from the cardiopulmonary exercise test at prestest. The system allows dynamically auto-adjust the paddling resistance in accordance to the patient's current hear rate and paddling rate, with the goal to maintain the patient's heart rate at the pre-determined heart rate zone through the training period.

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption (VO2-peak)	4 weeks	Peak oxygen consumption is measured by cardiopulmonary test.

Secondary Outcome Measures

Name	Time	Method
Peak workload	4 weeks	Peak workload is measured by cardiopulmonary exercise test
percentage of time (%time) within the pre-determined target heart rate	4 weeks	The ICRS outputs the heart rate-time plots and calculated the %time for each session

Trial Locations

Locations (1)

Department of rehabilitation, WanFang Hospital; 🇨🇳 Taipei City, Taiwan