Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

Summary

The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction.

The main questions it aims to answer are:

1. Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation)
2. Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire
3. Preliminary data on the fidelity and clinical efficacy of MICROFIT

Participants will be randomized to either MICROFIT + Usual Care, or Usual Care group.

Participants in both arms of the trial will:

* Undergo a series of investigations, including cardiopulmonary exercise test (CPET), dual xray absorptiometry (DEXA), echocardiogram, cardiac MRI scan, blood tests, at the start of the trial and again after 6 months
* Measure their living activity by using an activity tracker (GeneActiv) as well as a photographic diet diary for a week at the start of the trial and again after 6 months
* Complete a series of questionnaires to assess angina symptom burden, mental health and quality of life, at the start of the trial and again after 6 months.

Participants in the intervention arm of the study will:

1. Undergo MICROFIT intervention. MICROFIT includes a combination of exercise and diet management sessions over 24 weeks. It involves:

* 1:1 high-intensity interval training ('HIIT') sessions with a personal trainer and guidance on exercise sessions to be performed at home
* 1:1 sessions with a dietician to support them with improvements in diet.
2. Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist
3. Undergo an interview at the end of the study to discuss their experiences of participation in the study
4. Receive a debrief on their investigation results and progress made at the end of their study

Participants in the Usual Care arm of the study will:

1. Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction.
2. Receive a debrief on their investigation results and progress made at the end of their study
3. Undergo a 'taster' session with the personal trainer to discover what the intervention involves.

Conditions

• Microvascular Coronary Dysfunction
• Microvascular Angina
• Coronary Microvascular Dysfunction (CMD)

Interventions

OTHER

MICROFIT - personalised high intensity interval training exercise rehabilitation and dietary advice

MICROFIT is a 24-week long personalized one-on-one exercise and dietary education intervention, along with home exercise guided by personal trainers. Exercise intervention includes High Intensity Interval Training (HIIT) and dietary advice focuses on incorporation of a Mediterranean-type diet. Phase 1 - Induction (8 weeks) Exercise: Twice-weekly 1-hour personal trainer (PT) supervised exercise sessions. 45 minute homework exercise session once a week. Diet: 1-hour educational session with a dietician, followed by two 30-minute follow up sessions. Phase 2 - Consolidation (10 weeks) Exercise: Once weekly 1 hour PT sessions, two 45 minute homework sessions once a week. Diet: 30-minute sessions every 5 weeks. Phase 3 - Maintenance (6 weeks) Exercise: Supervised 1 hour PT sessions once every 3 weeks, 45-minute homework sessions three times a week. Diet: one final 30 minute session after week 3.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Royal United Hospitals Bath NHS Foundation Trust

  lead OTHER

Principal Investigators

• Ali Khavandi · Royal United Hospitals Bath NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-12

Primary Completion

2027-01-01

Completion

2027-01-01

Countries

• United Kingdom

Study Locations