Cardiac RehabilitationNCT04914169
The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study
An observational study of Cardiac Rehabilitation, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- ICRS
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2020to 30 Jul 2021
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects
Who may be able to join
- age of 20-50
- no regular exercise habits
- no documented cardiopulmonary disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- ICRS
- Keywords
- cardiac rehabilitation, cardiorespiratory fitness, aerobic exercise, endurance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICRSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: ICRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Peak workload
The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
Measured: 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.
Measured: 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.
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 posted4 Jun 2021
- Study start15 Apr 2020
- Primary completion13 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914169
- Sponsor's protocol ID
- N202010010
- Status last verified
- Aug 2021
- First submitted
- 24 May 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04914169
- Acronym / sponsor ID
- N202010010
- Conditions
- Cardiac Rehabilitation
- Keywords
- cardiac rehabilitation, cardiorespiratory fitness, aerobic exercise, endurance training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 4 Jun 2021 (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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indoor cycling training | – | Device: ICRS8 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). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects
Key inclusion criteria (3 listed)
- age of 20-50
- no regular exercise habits
- no documented cardiopulmonary disease
Key exclusion criteria (6 listed)
- abnormal lung function
- medications affecting exercise capacity
- hypertension
- diabetes mellitus
- recent illness including upper respiratory tract infection
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 |
|---|---|---|
| ICRSThe 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. | Device | Indoor cycling training |
Primary outcome
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.
3 secondary outcomes
Peak workload
Time frame: 4 weeks
Compliance of training during the training sessions
Time frame: 4 weeks
Averaged workload during the training sessions
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 4 Aug 2021.