NCT05496153

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

July 29, 2022

Last Update Submit

August 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • CPET

    Cardiopulmonary exercise testing

    Baseline and immediately after the intervention, about one month

Secondary Outcomes (2)

  • Quality of life

    Baseline and immediately after the intervention, about one month

  • RMR

    Baseline and immediately after the intervention, about one month

Study Arms (1)

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.

Behavioral: Adaptive posture-balance cardiac rehabilitation exercise

Interventions

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.

Cardiovascular diseases Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 90 years
  • With cardiovascular diseases

You may not qualify if:

  • abnormal blood pressure response
  • unstable angina pectoris
  • acute heart failure
  • congenital heart disease
  • severe musculoskeletal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 11, 2022

Study Start

December 1, 2020

Primary Completion

March 31, 2021

Study Completion

October 31, 2021

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations