- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496153
The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases
August 9, 2022 updated by: Ting Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tianjin
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Tianjin, Tianjin, China
- Tianjin Chest Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 18 and 90 years
- With cardiovascular diseases
Exclusion Criteria:
- abnormal blood pressure response
- unstable angina pectoris
- acute heart failure
- congenital heart disease
- severe musculoskeletal diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cardiovascular diseases Patients
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPET
Time Frame: Baseline and immediately after the intervention, about one month
|
Cardiopulmonary exercise testing
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Baseline and immediately after the intervention, about one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: Baseline and immediately after the intervention, about one month
|
Using 12-Item Short Form Survey questionnaire to assess the quality of life
|
Baseline and immediately after the intervention, about one month
|
RMR
Time Frame: Baseline and immediately after the intervention, about one month
|
Resting metabolic rate
|
Baseline and immediately after the intervention, about one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
July 29, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 11, 2022
Study Record Updates
Last Update Posted (Actual)
August 11, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Balance-based rehabilitation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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