Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

NCT06681896 | Recruiting

• 3 other identifiers: 340782TRP23-10002364259
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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:

• 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:
• 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.
• Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist
• Undergo an interview at the end of the study to discuss their experiences of participation in the study
• Receive a debrief on their investigation results and progress made at the end of their study
• Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction.
• Receive a debrief on their investigation results and progress made at the end of their study
• Undergo a 'taster' session with the personal trainer to discover what the intervention involves.

Conditions

Microvascular Coronary Dysfunction; Microvascular Angina; Coronary Microvascular Dysfunction (CMD)

Keywords

coronary microvascular dysfunction; HIIT; high intensity interval exercise training; exercise training; dietary rehabilitation; lifestyle advice; microvascular angina

Outcome Measures

Primary Outcomes (5)

• Establish recruitment rate

  A key feasibility outcome for a potential future randomised controlled trial will be to establish recruitment rates: defined as the proportion of eligible patients who accept the invitation to participate in the study.

  Week 0

• Establish retention rate

  A key feasibility outcome for a potential future randomised controlled trial will be to examine retention: defined as the proportion of recruited participants who complete the study.

  Week 24

• Establish adherence

  A key feasibility outcome for a potential future randomised controlled trial will be to examine adherence: defined as, for participants in the intervention arm, the proportion of offered sessions completed.

  Week 24

• Assess acceptability of the intervention

  A key feasibility outcome for a potential future randomised controlled trial will be to examine the acceptability of the intervention (MICROFIT) to participants and clinicians. This will be assessed qualitatively by an end of study interview.

  Week 24

• Assess acceptability of the study design

  A key feasibility outcome for a potential future randomised controlled trial will be to examine the acceptability of the study design. This will be assessed qualitatively by an end of study interview.

  Week 24

Secondary Outcomes (18)

• Change in anginal symptom burden

  Week 24

• Change in myocardial perfusion with quantitative stress MRI

  Week 24

• Change in myocardial oxygenation

  24 weeks

• Change in cardiorespiratory fitness

  24 weeks

• Change in blood pressure control

  24 weeks

Study Arms (2)

MICROFIT + Usual Care

EXPERIMENTAL

MICROFIT intervention will be delivered in addition to Usual Care arm clinical review and 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.

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

Usual Care

NO INTERVENTION

All patients will be reviewed clinically by a cardiologist. They will address cardiovascular risk factors and prescribe any therapies as indicated by current medical guidelines, for example statin or ACE inhibitors. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with NICE guidance, recommending 150 minutes of moderate exercise per week, encouraging a healthy, balanced diet, weight loss, reducing alcohol consumption and smoking cessation where necessary.

Interventions

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

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.

MICROFIT + Usual Care

Eligibility Criteria

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

You may qualify if:

• Age ≥18
• Angina or angina equivalent symptoms
• Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing \<40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8
• Evidence of microvascular dysfunction on ICA (CFR \<2.5 and/or AchFR \<1.5)

You may not qualify if:

• New York Heart Association class III/IV heart failure
• Severe left ventricular impairment (ejection fraction≤35%)
• Severe heart valve disease
• Significant cardiomyopathy (as assessed by a cardiologist)
• Severe hypertension (defined as blood pressure \>180/120mmHg (despite three anti-hypertensive agents)
• Uncontrolled arrhythmia
• A history of aortic dissection, recent (\<6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe acute or chronic renal failure, severe pulmonary fibrosis or interstitial lung disease (in line with other trials investigating HIIT exercise)
• Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT)
• Physical inability to participate in exercise
• Significant claustrophobia or metallic implants which would limit MRI imaging
• Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease)
• Current participation in another intervention-based trial
• Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, BS2 8ED, United Kingdom

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ali Khavandi

  Royal United Hospitals Bath NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Abramik

CONTACT

+44 1225 82109; joanna.abramik1@nhs.net

Ali Khavandi

CONTACT

+44 1225 821174; ali.khavandi@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 1 month after publication of results and ending 5 years after
• Access Criteria: Requests for data sharing will be reviewed on an individual basis upon request to the research team.

Locations

GB (2)