Cardiac RehabilitationREHAB-TAVRNCT05989594
Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR
A study testing Home-based mobile guided exercise-based cardiac rehabilitation and Routine Care in people with Cardiac Rehabilitation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Home-based mobile guided exercise-based cardiac rehabilitation and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing Transcatheter Aortic Valve Replacement (REHAB-TAVR): a Randomized Clinical Trial
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.
Read the detailed description
The purpose of our study was to investigate the effect of home-based mobile-guided exercise-based cardiac rehabilitation on the improvement of exercise capacity among patients undergoing transcatheter aortic valve replacement. 90 subjects will be recruited and followed up for a six-minute walk distance, short physical performance battery, exercise adherence, quality of life, frailty, nutritional status, sleep status, readmission rate, and all-cause mortality et al. The subjects will be invited to participate in on-site visits at 1, 3, and 6 months. Patients in the interventional group will receive a home-based mobile-guided exercise-based cardiac rehabilitation for 3 months. The home-based mobile-guided exercise-based cardiac rehabilitation is a multi-component intervention strategy including the preparation for discharge, family support, motivational interviews, health education, telephone follow-up, wearable devices, APP, et al. While the patients in the control group will receive routine care. For example, the preparation for discharge of the control group does not include the guidance of mobile-guided exercise-based cardiac rehabilitation, family support, and motivational interviews. After discharge, nurses will conduct telephone follow-ups once a month for the control group. Baseline data and outcomes will be collected in a Case Report Form.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Home-based mobile guided exercise-based cardiac rehabilitation, Routine Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based mobile guided exercise-based cardiac rehabilitationBehavioural
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.
Routine CareBehavioural
Discharge preparation, scheduled onsite follow-ups, telephone follow-ups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute Walk Distance
Distance walked in 6 minutes
Measured: Month 3
Secondary outcomes (3)
Change in 6-minute Walk Distance
Distance walked in 6 minutes
Measured: Month 6
Change in Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.
Measured: Month 3 and Month 6
Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS)
Evaluated by the Exercise Adherence Rating Scale (EARS)
Measured: Month1, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Mar 2024
- Primary completion31 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiyun Shen, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989594
- Sponsor's protocol ID
- B2022-062R
- Acronym
- REHAB-TAVR
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27913064Nagatomi 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.
PubMed 35534907Shen 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.
PubMed 38453208