The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases

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

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

    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Chest Hospital

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.
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.

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
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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