Lifestyle, SedentaryNCT04662307
An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness
A study testing Intelligent cardiopulmonary rehabilitation system (ICRS) in people with Lifestyle, Sedentary, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Sedentary
- What is being tested?
- Intelligent cardiopulmonary rehabilitation system (ICRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2020to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Sedentary healthy people
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of rehabilitation, WanFang Hospital
Taipei
Yen-Nung Lin, MD, MS, 0970746879, semitune@gmail.com
About this study
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
- Being tested
- Intelligent cardiopulmonary rehabilitation system (ICRS)
- Keywords
- cardiac rehabilitation, cardiorespiratory fitness, aerobic exercise, endurance training
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intelligent cardiopulmonary rehabilitation system (ICRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (VO2-peak)
Peak oxygen consumption is measured by cardiopulmonary test.
Measured: 4 weeks
Secondary outcomes (2)
Peak workload
Peak workload is measured by cardiopulmonary exercise test
Measured: 4 weeks
percentage of time (%time) within the pre-determined target heart rate
The ICRS outputs the heart rate-time plots and calculated the %time for each session
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start15 Dec 2020
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle, SedentaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
- Investigators
- Yen-Nung Lin, MD, Principal investigator, Wan-Fang Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662307
- Sponsor's protocol ID
- N202005081
- Status last verified
- May 2022
- First submitted
- 25 Nov 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness
- ClinicalTrials.gov ID
- NCT04662307
- Acronym / sponsor ID
- N202005081
- Conditions
- Lifestyle, Sedentary
- Keywords
- cardiac rehabilitation, cardiorespiratory fitness, aerobic exercise, endurance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intelligent cardiopulmonary rehabilitation system (ICRS) | Experimental | Device: 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Sedentary healthy people
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intelligent cardiopulmonary rehabilitation system (ICRS) |
Primary outcome
Peak oxygen consumption (VO2-peak)
Time frame: 4 weeks
Peak oxygen consumption is measured by cardiopulmonary test.
2 secondary outcomes
Peak workload
Time frame: 4 weeks
percentage of time (%time) within the pre-determined target heart rate
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Nung Lin, MD principal investigator
Wan-Fang Hospital, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent cardiopulmonary rehabilitation system (ICRS) in people with Lifestyle, Sedentary, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2-peak) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.