The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study

The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study in Healthy Subjects

The Intelligent Cardiopulmonary Rehabilitation System (ICRS) was developed to automatically control the resistance of pedaling in combination with the conventional stationary bike by monitoring the user's heart rate for clinical use. To test its feasibility, 8 healthy participants were recruited to complete 12 sessions (3 times per week for 4 weeks) of indoor cycling on the stationary bicycle with ICRS. Subjects were received cardiopulmonary exercise testing (CPET) before and after the biking sessions.The 60-80% of heart rate reserve (HRR) of each participant was determined according to their first CPET results. The algorithm of ICRS was designed to enable the bicycle to adjust its training intensity in accordance with the subject's 60-80% HRR which was detected by wearing a wristband heart rate monitor during cycling. With ICRS, the participants' heart rates during training were expected to fall in the 60-80% HRR, increasing their cardiopulmonary fitness after 12 sessions of indoor cycling.

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Device: ICRS

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Wan Fan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy subjects

Description

Inclusion Criteria:

• age of 20-50
• no regular exercise habits
• no documented cardiopulmonary disease

Exclusion Criteria:

• abnormal lung function
• medications affecting exercise capacity
• hypertension
• diabetes mellitus
• recent illness including upper respiratory tract infection
• the presence of any factor that may limit ability to participate in the CPET

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Indoor cycling training; 8 subjects were asked to complete indoor cycling training, 3 times a week for 4 weeks. Each session of training consisted of 30-minute stationary biking (5 minutes of warm-up, 20 minutes of training and 5 minutes of cooldown).

Device: ICRS; The ICRS enables a stationary bike to automatically adjust the pedaling resistance (i.e. training intensity) according to the subject's heart rate. The training intensity is determined by monitoring whether the subject is able to maintain a 50-70 cycles/min cadence with 60-80% HRR. Subjects heart rate was detected by a wearable device for heart rate, synching with the stationary bike.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen consumption (VO2-peak)	Oxygen consumption (VO2- peak) were measured during our cardiopulmonary test (with a incremental biking and a gas analyzer). The workload was increased at a ramp rate of 5-10 W/min. A cadence at 50~70 rpm was to be maintained.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak workload	The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.	4 weeks
Compliance of training during the training sessions	The percentage of time that a subject's heart rate falls in his or her estimated 60-80% HRR over the 12 sessions of training.	4 weeks
Averaged workload during the training sessions	The averaged workload (watt) that a subject paddled on the stationary bike over the 12 sessions of training.	4 weeks

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: aerobic exercise; cardiorespiratory fitness; cardiac rehabilitation; endurance training
• Other Study ID Numbers: N202010010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No