Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement? (RECOVER-TAVR)

November 8, 2017 updated by: Royal Brompton & Harefield NHS Foundation Trust
The aim of this pilot study is to assess function, independence, frailty and emotional status in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at 4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac rehabilitation programme and the remaining 15 patients will receive standard of care. All patients will return to clinic at 3 months and 6 months post implant and undertake the functional, independence, frailty and emotional testing again.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND

Aortic stenosis is the most common form of valvular heart disease in the elderly and is associated with high morbidity and mortality once cardiac symptoms develop (1). In patients who are at high risk for serious complications during or after surgery, Transcatheter Aortic Valve Implantation (TAVI) has been shown to result in reductions in mortality and improvement in quality of life compared with medical therapy (2, 3).

Due to the ageing and increasingly complex nature of patients with aortic stenosis, frailty and functional assessment has become a high-priority theme within patient management. Frailty is a term widely used to describe a multidimensional syndrome of loss of reserves (energy, physical ability, cognition, health) that gives rise to vulnerability. Several publications deal with the impact of frailty on mortality and morbidity in the elderly population. Functional status is evaluated by the ability to undertake Activities of Daily Living (ADL) and it has been demonstrated that frailty and the onset of dependence in ADL are strongly associated.

4.2 PRE-CLINICAL DATA/CLINICAL DATA

Cardiac rehabilitation is a complex intervention offered to patients with heart disease and includes components of health education, advice on cardiovascular risk reduction, physical activity and stress management. Cardiac rehabilitation and physical activity are recommended treatments after cardiac valve surgery and positively improves morbidity, exercise capacity and quality of life or emotional well-being. The National Institute for Healthcare Excellence and The Department of Health and wider European guidelines agree that patients who have received heart valve replacements will benefit from cardiac rehabilitation.

4.3 STUDY RATIONALE AND RISK/BENEFIT ANALYSIS

A literature search has not revealed any publications which specifically outline the impact of receiving a programme of cardiac rehabilitation, following TAVR and this study aims to address that question. The ethical dilemma of conducting research in elderly patients who have undergone TAVR can be associated with clinical trials in other elderly populations. The dilemma consists of the need to develop new and better treatment options for a particular group of patients whilst protecting the patient from harm. We anticipate that this study will allow us to understand the feasibility of undertaking this study in a group of patients who have agreed to participate in a research study prior to the TAVR procedure. The pilot study will help us to understand the logistics of providing a cardiac rehabilitation programme for patients and the data we generate will allow us to understand if there are any benefits related to functional, independence, frailty and emotional domains for this patient group. The outcomes from this pilot study may allow us to plan future studies with the aim of developing appropriate guidelines related to the provision of cardiac rehabilitation for this patient group.

4.4 MANAGEMENT OF POTENTIAL STUDY RISKS

Patients who are eligible for TAVR, as determined by the multi-disciplinary team, will be seen in the out-patient clinic or in-patient area by the Research Nurse Manager or delegated research nurse. Full informed consent will be obtained before any research intervention is undertaken. Functional, independence, frailty and emotional assessment will include 6 minute walk teat, 4m gait speed walk, hand grip strength, questionnaires and cognitive assessment.

Patients will undergo TAVR as per routine practice and they will be discharged when safe to do so. The research nurse team will collect clinical data during the admission. All patients will attend clinic for review at 4 weeks post implant, research consent will be reaffirmed and the patients will be randomised to receive a cardiac rehabilitation programme or standard of care.

A personalised programme of cardiac rehabilitation will be developed by expert physiotherapists. Patients in the cardiac rehab group will be assessed for the cardiac rehabilitation prior to any intervention taking place. Patients are monitored during exercise and full emergency equipment is available should there be an emergency.

Patients who are in the standard of care group will have access to the TAVR nurse specialist as well as the designated Consultant and research nurse team to ask any advice at any time.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, UB9 6JH
        • Royal Brompton and Harefield NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe symptomatic aortic stenosis accepted for Trans Catheter Aortic Valve Replacement
  • Age ≥75 years;
  • Participant able and willing to give written informed consent;
  • Participant able (in the Investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

  • Subjects may not enter the study if ANY of the following apply:
  • Intervention deemed inappropriate due to co-morbidity or frailty;
  • Life expectancy less than one year due to co-morbidity;
  • Previous AVR or TAVI;
  • Predominant aortic regurgitation (AR).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardiac Rehabilitation
Patients will return to the out-patient clinic at 4 weeks post - TAVR and research consent will be re-affirmed. Patients will be randomised to receive a programme of cardiac rehabilitation or routine care at this point. Patients randomised to receive cardiac rehabilitation will meet the cardiac rehab team and undergo baseline assessment for the programme. This involves recording height, weight, blood pressure, oxygen saturation and heart rate and rhythm. An individualised programme will be established to meet the needs of each patient. The patients will undergo a 6 week programme of cardiac rehab. Patients who are not allocated to the intervention group will not receive a cardiac programme and will have access to the TAVR nurse specialist team as would be usual care.
Other: Cardiac Rehabilitation
NO_INTERVENTION: Standard of care
15 patients will be randomised to receive a programme of cardiac rehabilitation, and 15 patients will receive standard of care which does not include a routine rehabilitation programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients willing to undertake cardiac rehabilitation following TAVR.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity by 4 metre gait speed.
Time Frame: 6 months
Measured at baseline, 6 weeks, 3 months and 6 months.
6 months
Frailty assessment via the FRIED criteria.
Time Frame: 6 months
Measured at baseline, 6 weeks, 3 months and 6 months.
6 months
Hospital Anxiety and Depression score
Time Frame: 6 months
Measured at baseline, 6 weeks, 3 months and 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 13, 2017

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (ESTIMATE)

October 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/OO/0687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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