An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

NCT ID: NCT04662307

Last Updated: 2022-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2023-01-15

Brief Summary

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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

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Conditions

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Lifestyle, Sedentary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A small group of healthy subjects with sedentary lifestyle is recruited to validate the ICRS. They receive training with ICRS three sessions a week, for a total of 12 sessions. The outcome assessments are performed before and after the training.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intelligent cardiopulmonary rehabilitation system (ICRS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yen-Nung Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Wan-Fang Hospital, Taipei Medical University

Locations

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Department of rehabilitation, WanFang Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Yen-Nung Lin, MD, MS

Role: primary

0970746879

Other Identifiers

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N202005081

Identifier Type: -

Identifier Source: org_study_id

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