The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study

Cardiac Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914169
• Other study ID #: N202010010
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 30, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Wan Fan Hospital	Taipei

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)	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	Peak workload	The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.	4 weeks
Secondary	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
Secondary	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