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Completed

NCT Number: NCT04914169

The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study

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.

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Key information

Conditions

Cardiac Rehabilitation

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wan Fan Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICRS

Device

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.

Primary outcomes

  1. Peak oxygen consumption (VO2-peak)

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Peak workload

    Time frame: 4 weeks

    The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.

  2. Compliance of training during the training sessions

    Time frame: 4 weeks

    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.

  3. Averaged workload during the training sessions

    Time frame: 4 weeks

    The averaged workload (watt) that a subject paddled on the stationary bike over the 12 sessions of training.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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