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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05496153
Other study ID # Balance-based rehabilitation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date October 31, 2021

Study information

Verified date August 2022
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Behavioral:
Adaptive posture-balance cardiac rehabilitation exercise
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.

Locations

Country Name City State
China Tianjin Chest Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CPET Cardiopulmonary exercise testing Baseline and immediately after the intervention, about one month
Secondary Quality of life Using 12-Item Short Form Survey questionnaire to assess the quality of life Baseline and immediately after the intervention, about one month
Secondary RMR Resting metabolic rate Baseline and immediately after the intervention, about one month
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