An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

NCT04662307 | Unknown DMC

• 1 other identifier: N202005081
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lifestyle, Sedentary

Keywords

cardiac rehabilitation; cardiorespiratory fitness; aerobic exercise; endurance training

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (VO2-peak)

  Peak oxygen consumption is measured by cardiopulmonary test.

  4 weeks

Secondary Outcomes (2)

• Peak workload

  4 weeks

• percentage of time (%time) within the pre-determined target heart rate

  4 weeks

Study Arms (1)

Intelligent cardiopulmonary rehabilitation system (ICRS)

EXPERIMENTAL

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)

Interventions

Intelligent cardiopulmonary rehabilitation system (ICRS) 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.

Intelligent cardiopulmonary rehabilitation system (ICRS)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Sedentary healthy people

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Department of rehabilitation, WanFang Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Yen-Nung Lin, MD

  Wan-Fang Hospital, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 10, 2020
• Study Start: December 15, 2020
• Primary Completion: December 15, 2022
• Study Completion: January 15, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)