Effectiveness of early cardiac rehabilitation in patients with heart valve surgery

ISRCTN ISRCTN54158701
DOI https://doi.org/10.1186/ISRCTN54158701
Submission date
27/03/2021
Registration date
16/05/2021
Last edited
14/06/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Complications of heart valve surgery lead to physical inactivity and produce harmful effects. The present study aimed to investigate the roles of a cardiac rehabilitation programme and its long-term effects in patients with heart valve surgery following the day of post-operation in patients after heart valve surgery in a hospital setting.

Who can participate?
Adults over 18 years, who will undergo heart valve surgery.

What does the study involve?
Patients with heart valve surgery were randomly assigned randomized to the an early cardiac rehabilitation group (intervention) or a usual care group (control).

What are the possible benefits and risks of participating?
Participants could enhance their physical activity level and promote long-term survival. No risks.

Where is the study run from?
The First Affiliated Hospital of An Hui Medical University (China)

When is the study starting and how long is it expected to run for?
January 2018 to December 2019

Who is funding the study?
Investigator-initiated and funded

Who is the main contact?
Dr Wei Xue, weixue20@126.com

Contact information

Dr Wei Xue
Scientific

Meishan Road
Hefei city
230032
China

ORCiD logoORCID ID 0000-0002-6739-8784
Phone +86 (0)551-68908794
Email weixue20@126.com

Study information

Study designSingle-blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleEffectiveness of early cardiac rehabilitation in patients with heart valve surgery: a randomized trial
Study objectivesAn early cardiac rehabilitation programme can enhance the physical activity in patients with heart valve surgery and long-term survival.
Ethics approval(s)Approved 04/01/2018, Medical ethics committee of An Hui Medical University (Meishan Road, Hefei City, China; +86 (0)551-65161000; ethicschair@ahmu.edu.cn), ref: none provided
Health condition(s) or problem(s) studiedCardiac rehabilitation of patients with heart valve surgery
InterventionA total of 97 consecutive patients who took heart valve surgery were enrolled in the study, after applying inclusion and exclusion criteria, 87 patients were included in this study and met the sample size requirements.

The randomization programme was created using a computer and executed by an investigator who is not involved in the treatment and recruitment of patients. The allocation of patients was screened, applying numbered in the sealed and opaque envelopes. On the first day of treatment after surgery, the envelope that was allocated to the patient was unfolded by the physical therapist.

Patients were randomly assigned to two groups: those who received cardiac rehabilitation or those who received usual care.
Before surgery (baseline), hospital discharge, and after 6 months following up, the physical capacity and psychological status were measured.
This rehabilitation exercise program comprises lower and upper extremity exercise in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m on the ward. The exercise included 4 sessions and last four days, three times a day, with about 30 minutes each time. After the rehabilitation exercise, patients continued with gait practicing for up to 500 m and carried out endurance training applying a stationary bike in the rehabilitation center of the hospital. The training session took place three times a day with about 30 minutes each time and until they were discharged from the hospital.
Intervention typeBehavioural
Primary outcome measurePhysical function was measured using the Short physical performance battery (SPPB) at baseline, the day of hospital discharge, and 6 months later
Secondary outcome measuresThe mental health was measured with a mental component summary (MCS) from the 12-item Short-Form Health Survey at baseline, the day of hospital discharge, and 6 months later
Overall study start date04/01/2018
Completion date30/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Total final enrolment97
Key inclusion criteria1. Elective left-sided or right-sided heart valve surgery, including aortic, mitral, tricuspid, and pulmonary valve replacement
2. Over 18 years of age
3. Able to understand and complete measurements
4. Provide informed written consent
Key exclusion criteria1. Ischaemic heart disease before surgery
2. Diseases in the musculoskeletal system
3. Comorbidity complicating physical activity
4. Expected to not cooperate in the trial instructions
Date of first enrolment30/01/2018
Date of final enrolment30/06/2019

Locations

Countries of recruitment

  • China

Study participating centre

The First Affiliated Hospital of An Hui Medical University
Meishan Road
Hefei City
230032
China

Sponsor information

First Affiliated Hospital of Anhui Medical University
Hospital/treatment centre

Meishan Road
Hefei
230032
China

Phone +86 (0)551-65161000
Email lql@ahmu.edu.cn
Website http://www.ayfy.com/
ROR logo "ROR" https://ror.org/03t1yn780

Funders

Funder type

Other

investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/12/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 24/01/2022 24/01/2022 No No
Results article 01/07/2022 14/06/2023 Yes No

Additional files

ISRCTN54158701_BasicResults_24Jan22.pdf

Editorial Notes

14/06/2023: Publication reference added.
24/01/2022: The intention to publish date was changed from 01/05/2021 to 30/12/2022. The basic results of this trial have been uploaded as an additional file.
16/04/2021: Trial's existence confirmed by Medical ethics committee of An Hui Medical University .