An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

Lifestyle, Sedentary Clinical Trial

Official title:

An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662307
• Other study ID #: N202005081
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: January 15, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 15, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lifestyle, Sedentary

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of rehabilitation, WanFang Hospital	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	Peak oxygen consumption (VO2-peak)	Peak oxygen consumption is measured by cardiopulmonary test.	4 weeks
Secondary	Peak workload	Peak workload is measured by cardiopulmonary exercise test	4 weeks
Secondary	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