Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR

NCT05989594 | Unknown

• 1 other identifier: B2022-062R
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter Aortic Valve Replacement.

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute Walk Distance

  Distance walked in 6 minutes

  Month 3

Secondary Outcomes (3)

• Change in 6-minute Walk Distance

  Month 6

• Change in Short Physical Performance Battery (SPPB)

  Month 3 and Month 6

• Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS)

  Month1, Month 3 and Month 6

Other Outcomes (27)

• All-cause Rehospitalizations and death

  Month 3 and Month 6

• Handgrip Strength

  Month 3 and Month 6

• Frailty Status Assessed by the Fried Frailty Criteria

  Month 3 and Month 6

Study Arms (2)

The REHAB-TAVR group

ACTIVE COMPARATOR

For the REHAB-TAVR group, discharge preparation will involve an exercise endurance test, exercise prescription guidance, motivational interviews, instruction on telerehabilitation, and the provision of family and peer support. Following discharge, patients will be required to adhere to their personalized exercise prescription and attend scheduled onsite follow-ups after discharge. The management model employed for this group is called home-based mobile guided exercise-based cardiac rehabilitation.

Behavioral: Home-based mobile guided exercise-based cardiac rehabilitation

The Routine-TAVR group

OTHER

Preparation for discharge will only involve an exercise endurance test and the guidance of an exercise prescription for the Routine-TAVR group. Following discharge, nurses will conduct monthly telephone follow-ups to check on the patient's progress. Additionally, patients will be scheduled for onsite follow-ups at the Outpatient Department.

Behavioral: Routine Care

Interventions

Home-based mobile guided exercise-based cardiac rehabilitation BEHAVIORAL

Discharge preparation, telerehabilitation, scheduled onsite follow-ups, telephone follow-ups, self-reporting, health education, online communication, family and peer support, mailing letters, institutional referrals, and security management.

The REHAB-TAVR group

Routine Care BEHAVIORAL

Discharge preparation, scheduled onsite follow-ups, telephone follow-ups

The Routine-TAVR group

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years and ≤ 89 years old;
• Patients scheduled to be discharged after TAVR;
• Those who have the ability to read and write, and have normal speech and communication skills;
• Patients and their families are willing to participate in this study;
• Patients or family members have the ability to use mobile and an app.

You may not qualify if:

• Serious complications occur before discharge (such as major bleeding, stroke, valve detachment, moderate or above perivalve leakage, coronary artery occlusion, etc.) ;
• Patients who are unable to participate in postoperative exercise rehabilitation due to limb dysfunction;
• Being in palliative care or treatment;
• Those with other Contraindication to exercise-based cardiac rehabilitation (such as resting ECG changes indicating significant ischemia, acute myocardial infarction or other acute cardiac events, unstable angina, uncontrolled arrhythmia, heart failure decompensation, etc.);
• Currently participating in other rehabilitation projects.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (3)

• Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.

  PMID: 27913064 BACKGROUND

• Nagatomi Y, Ide T, Higuchi T, Nezu T, Fujino T, Tohyama T, Nagata T, Higo T, Hashimoto T, Matsushima S, Shinohara K, Yokoyama T, Eguchi A, Ogusu A, Ikeda M, Ishikawa Y, Yamashita F, Kinugawa S, Tsutsui H. Home-based cardiac rehabilitation using information and communication technology for heart failure patients with frailty. ESC Heart Fail. 2022 Aug;9(4):2407-2418. doi: 10.1002/ehf2.13934. Epub 2022 May 9.

  PMID: 35534907 RESULT

• Shen Z, Mi S, Huang C, Zhou D, Pan W, Xu X, Lin Y, Zhang Y. Home-based mobile-guided exercise-based cardiac rehabilitation among patients undergoing transcatheter aortic valve replacement (REHAB-TAVR): protocol for a randomised clinical trial. BMJ Open. 2024 Mar 7;14(3):e080042. doi: 10.1136/bmjopen-2023-080042.

  PMID: 38453208 DERIVED

Study Officials

• Zhiyun Shen

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyun Shen

CONTACT

+8318317089276; Shen.zhiyun@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share