An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

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.

Study Overview

• Status: Recruiting
• Conditions: Lifestyle, Sedentary
• Intervention / Treatment: Device: Intelligent cardiopulmonary rehabilitation system (ICRS)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • Recruiting
    • Department of rehabilitation, 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:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Intelligent cardiopulmonary rehabilitation system (ICRS); Participants are required to wear a wristband heart rate monitor and exercise on a cycling ergometer-based ICRS for 30 minutes (5 minute of warm-up, 20 minutes of training followed by 5 minutes of cooldown). The target intensity for the 20-min training period is set at 60%~80% HRR determined in the pretest of cardiopulmonary exercise test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen consumption (VO2-peak)	Peak oxygen consumption is measured by cardiopulmonary test.	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Yen-Nung Lin, MD, Wan-Fang Hospital, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): January 15, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: aerobic exercise; cardiorespiratory fitness; cardiac rehabilitation; endurance training
• Other Study ID Numbers: N202005081

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