StrokeNCT04833400
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke
A study testing ICRS and TAET in people with Stroke, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- ICRS and TAET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jan 2022to 1 Aug 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
- Aged 20-75 y/o
- Healthy people
- Chronic stroke > 6 months
- Able to walk independently > 6 minutes with or without orthosis
- Able to use stationary bike
- MRS(Modified Rankin Scale) ranged 1 to 3
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 aerobic training
- 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
WanFang Hospital
New Taipei City
Yen-Nung Lin, MD, MS, 0970746879, semitune@gmail.com
About this study
Official title: Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study
By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke.
Read the detailed description
Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity.
To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity.
A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.
- Conditions
- Stroke
- Being tested
- ICRS, TAET
- Keywords
- cardiopulmonary exercise, cardiorespiratory fitness, aerobic training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICRSDevice
Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
TAETDevice
Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intelligent cardiopulmonary rehabilitation system (ICRS) | Experimental | The ICRS is very likely to the conventional stationary biking, but with an algorithm that automatically controls the resistance of pedalling, considering the instant heart rate and cadence, to keep the heart rate within the targeted heart rate zone. Receives: Device: ICRS |
| Traditional aerobic exercise training (TAET) | Active comparator | The TAET is performed with stationary biking, with intensity being set as subjective rating of perceived exertion at a "somewhat hard" to "hard" level. The resistance of pedaling is ad-justed by the user or physical therapist. Receives: Device: TAET |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative VO2-peak (mL/kg/min)
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
Measured: 4 weeks
Secondary outcomes (3)
6-min walk test
The 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.
Measured: 4 weeks
absolute VO2-peak (mL/min)
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
Measured: 4 weeks
workload-peak (Watt)
The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
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 posted6 Apr 2021
- Study start25 Jan 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833400
- Sponsor's protocol ID
- N202010012
- Status last verified
- Jul 2022
- First submitted
- 3 Jan 2021
- Last updated
- 20 Jul 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04833400
- Acronym / sponsor ID
- N202010012
- Conditions
- Stroke
- Keywords
- cardiopulmonary exercise, cardiorespiratory fitness, aerobic training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 6 Apr 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.
By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke.
Detailed description
Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity.
To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity.
A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intelligent cardiopulmonary rehabilitation system (ICRS) | Experimental | Device: ICRSThe ICRS is very likely to the conventional stationary biking, but with an algorithm that automatically controls the resistance of pedalling, considering the instant heart rate and cadence, to keep the heart rate within the targeted heart rate zone. |
| Traditional aerobic exercise training (TAET) | Active comparator | Device: TAETThe TAET is performed with stationary biking, with intensity being set as subjective rating of perceived exertion at a "somewhat hard" to "hard" level. The resistance of pedaling is ad-justed by the user or physical therapist. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 20-75 y/o
- Healthy people
- Chronic stroke > 6 months
- Able to walk independently > 6 minutes with or without orthosis
- Able to use stationary bike
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 aerobic training
- 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 |
|---|---|---|
| ICRSPatients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks. | Device | Intelligent cardiopulmonary rehabilitation system (ICRS) |
| TAETPatients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks. | Device | Traditional aerobic exercise training (TAET) |
Primary outcome
relative VO2-peak (mL/kg/min)
Time frame: 4 weeks
oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
3 secondary outcomes
6-min walk test
Time frame: 4 weeks
absolute VO2-peak (mL/min)
Time frame: 4 weeks
workload-peak (Watt)
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 20 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICRS and TAET in people with Stroke, 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 6 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 20 Jul 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?
relative VO2-peak (mL/kg/min) (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 20 Jul 2022.