Cardiac RehabilitationNCT05496153
The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases
A study testing Adaptive posture-balance cardiac rehabilitation exercise in people with Cardiac Rehabilitation and Exercise Therapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The whole experiment included one-month APBCRE therapy and two assessments. The one-month APBCRE consisted of twelve exercise sessions, evenly three times per week. At baseline and after rehabilitation, participants underwent one assessment, including car-diopulmonary exercise testing (CPET), resting metabolic rate… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Rehabilitation, Exercise Therapy, Balance Exercises
- What is being tested?
- Adaptive posture-balance cardiac rehabilitation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Oct 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years
- With cardiovascular diseases
Who cannot join
- abnormal blood pressure response
- unstable angina pectoris
- acute heart failure
- congenital heart disease
- severe musculoskeletal diseases
Trial locations and contacts
1 site in 1 country.
About this study
The whole experiment included one-month APBCRE therapy and two assessments. The one-month APBCRE consisted of twelve exercise sessions, evenly three times per week. At baseline and after rehabilitation, participants underwent one assessment, including car-diopulmonary exercise testing (CPET), resting metabolic rate (RMR) detection, and quality of life questionnaire (QoL). The primary outcomes were exercise capacity measured by function parameters at anaerobic threshold (AT) and other CPET physiological indexes. The secondary endpoints were the RMR level and QoL score.
- Being tested
- Adaptive posture-balance cardiac rehabilitation exercise
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive posture-balance cardiac rehabilitation exerciseBehavioural
The process of APBCRE consisted of four parts: breathing training and warm-up, aerobic exercise, resistance exercise, and flexibility exercise. The first part lasted for 5-15 minutes, based on balance exercise. The specific steps of balance exercise included stretching of upper limbs, legs, waist, and other parts. And the second part was generally moderate-intensity endurance exercise, thresholding for 60%-75% VO2max/kg metabolic equivalents (METs), 60%-70% maximum heart rate, rating of perceived exertion (RPE) Borg grade 12-13. The exercise duration of this part was usually 30 min. During the self-created APBCRE, the resistance exercise was carried out with the help of the body-building vehicle, and its power was adjusted based on danger assessment level and oxygen uptake at anaerobic threshold. The last part usually lasted for 5-10 min for each-level participants. The total exercise time for one session was generally 50-70 min.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular diseases Patients | Experimental | Subjects were recruited from outpatients with CVDs, under 18 years of age. All pa-tients have been verified the willingness of participating before the experiment. Patients was excluded if having abnormal blood pressure response, unstable angina pectoris, acute heart failure, congenital heart disease, and severe musculoskeletal diseases limiting. Receives: Behavioral: Adaptive posture-balance cardiac rehabilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPET
Cardiopulmonary exercise testing
Measured: Baseline and immediately after the intervention, about one month
Secondary outcomes (2)
Quality of life
Using 12-Item Short Form Survey questionnaire to assess the quality of life
Measured: Baseline and immediately after the intervention, about one month
RMR
Resting metabolic rate
Measured: Baseline and immediately after the intervention, about one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Dec 2020
- Primary completion31 Mar 2021
- Study completion31 Oct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Li, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496153
- Sponsor's protocol ID
- Balance-based rehabilitation
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT05496153
- Acronym / sponsor ID
- Balance-based rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 11 Aug 2022 (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 whole experiment included one-month APBCRE therapy and two assessments. The one-month APBCRE consisted of twelve exercise sessions, evenly three times per week. At baseline and after rehabilitation, participants underwent one assessment, including car-diopulmonary exercise testing (CPET), resting metabolic rate (RMR) detection, and quality of life questionnaire (QoL). The primary outcomes were exercise capacity measured by function parameters at anaerobic threshold (AT) and other CPET physiological indexes. The secondary endpoints were the RMR level and QoL score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular diseases Patients | Experimental | Behavioral: Adaptive posture-balance cardiac rehabilitation exerciseSubjects were recruited from outpatients with CVDs, under 18 years of age. All pa-tients have been verified the willingness of participating before the experiment. Patients was excluded if having abnormal blood pressure response, unstable angina pectoris, acute heart failure, congenital heart disease, and severe musculoskeletal diseases limiting. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 90 years
- With cardiovascular diseases
Key exclusion criteria (5 listed)
- abnormal blood pressure response
- unstable angina pectoris
- acute heart failure
- congenital heart disease
- severe musculoskeletal diseases
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 |
|---|---|---|
| Adaptive posture-balance cardiac rehabilitation exerciseThe process of APBCRE consisted of four parts: breathing training and warm-up, aerobic exercise, resistance exercise, and flexibility exercise. The first part lasted for 5-15 minutes, based on balance exercise. The specific steps of balance exercise included stretching of upper limbs, legs, waist, and other parts. And the second part was generally moderate-intensity endurance exercise, thresholding for 60%-75% VO2max/kg metabolic equivalents (METs), 60%-70% maximum heart rate, rating of perceived exertion (RPE) Borg grade 12-13. The exercise duration of this part was usually 30 min. During the self-created APBCRE, the resistance exercise was carried out with the help of the body-building vehicle, and its power was adjusted based on danger assessment level and oxygen uptake at anaerobic threshold. The last part usually lasted for 5-10 min for each-level participants. The total exercise time for one session was generally 50-70 min. | Behavioural | Cardiovascular diseases Patients |
Primary outcome
CPET
Time frame: Baseline and immediately after the intervention, about one month
Cardiopulmonary exercise testing
2 secondary outcomes
Quality of life
Time frame: Baseline and immediately after the intervention, about one month
RMR
Time frame: Baseline and immediately after the intervention, about one month
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 11 Aug 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.
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?
A study testing Adaptive posture-balance cardiac rehabilitation exercise in people with Cardiac Rehabilitation and Exercise Therapy, run by Chinese Academy of Medical Sciences at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 11 Aug 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 China. 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?
CPET (time frame: Baseline and immediately after the intervention, about one month). 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 Aug 2022.