Effect of a Cardiac Rehabilitation (CR) Programme on Molecular Mechanisms

Effect of a Cardiac Rehabilitation (CR) Programme on Protein Molecules Associated With Arterial Function, and an Exploration of Reasons for Agreeing or Declining to Participate in a CR Programme

This study will evaluate the effect of a cardiac rehabilitation (CR) programme on blood protein molecules that may improve the function of arteries in coronary artery disease (CAD) patients who have suffered a heart attack. CAD patients who have either agreed or disagreed to take part in a CR programme will be recruited. This will allow a comparison of the study measurements between a group of patients who complete a CR programme and a group of patients who do not.

The other objective of this study is to perform interviews with the study participants and their significant others (i.e. spouse, family member, or a close friend) to listen to the reasons why patients agreed or disagreed to take part in a CR programme.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Coronary Arteriosclerosis
• Intervention / Treatment: Behavioral: Exercise-based cardiac rehabilitation

Detailed Description

An exercise-based cardiac rehabilitation (CR) programme is an established method of secondary prevention of coronary artery disease (CAD). Moreover, there is a body of evidence that supports the ability of this intervention to reduce hospital readmissions and cardiovascular mortality. However, despite the proven benefit, CR programmes are underutilised worldwide. Moreover, the molecular mechanisms responsible for orchestrating the beneficial physiological adaptations induced by a CR programme are poorly understood.

Therefore, this study will evaluate the effect of a CR programme on novel molecular mechanisms and endothelial function in post-myocardial infarction CAD patients. Additionally, semi-structured interviews will be conducted with study participants and their significant others (i.e. spouse, family member, or a close friend) to explore the reasons why patients may agree or disagree to take part in a CR programme. Altogether, this study will provide physiological and detailed qualitative information that may help to provoke an increased participation in CR programmes.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United Kingdom
  • Co. Antrim
    • Belfast, Co. Antrim, United Kingdom, BT9 7AB
      • Belfast Health and Social Care Trust (Belfast City Hospital, Mater Hospital, and Royal Victoria Hospital)
  • Co. Down
    • Dundonald, Co. Down, United Kingdom, BT16 1RH
      • South Eastern Health and Social Care Trust (Ulster Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post-myocardial infarction coronary artery disease patients who have been invited to participate in a phase-III cardiac rehabilitation programme with the Belfast Health and Social Care Trust or South Eastern Health and Social Care Trust.

Description

Inclusion Criteria:

• Formally diagnosed coronary artery disease with evidence of ST- elevated or non-ST elevated myocardial infarction, as determined by evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia, and the detection of a rise and / or fall in cardiac biomarker values (preferably cardiac troponin), with at least one value above the 99th percentile upper reference limit, along with at least one of the following:

Symptoms of ischaemia, such as: extreme fatigue, breathlessness, chest pain, and heart palpitations.

New or presumed new significant ST-segment-T wave changes or new left bundle branch block.

Development of pathological Q waves on the electrocardiogram.

Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Identification of an intracoronary thrombus by angiography

• Over 18 years of age.
• Male or Female.
• Provision of informed consent.
• Ability to speak and write in English.
• Patients who have agreed to participate in a phase-III cardiac rehabilitation programme must be willing to attend the supervised group exercise sessions.
• No hospital readmissions with unstable symptoms (e.g. chest pain, shortness of breath, discomfort, or nausea) during the previous 4-weeks.
• Willing to comply with trial requirements.

Exclusion Criteria:

• Unstable angina pectoris (angina at rest or persistent angina regardless of pharmacological treatment e.g. glyceryl trinitrate).
• Uncontrolled cardiac arrhythmia.
• Survivor of cardiac arrest or cardiogenic shock.
• Any form of anaemia (haemoglobin < 90 grams / litre).
• Hepatic failure.
• Uncontrolled hypertension (resting systolic measurement > 180 mm Hg and / or diastolic measurement > 100 mm Hg).
• History of Raynaud's phenomenon.
• Congenital or acquired physical abnormalities of both arms.
• Consumption of vitamins, herbal, testosterone, estrogen/ progesterone, or antioxidant supplementation.
• Pregnant.
• History of or diagnosed with any form of cancer.
• Current participation in a different research study.

Patient Inclusion Criteria for Interview Component of Study:

• Patient has either declined or agreed to participate in a phase-III or phase-IV cardiac rehabilitation programme.
• Sufficient English language skills to understand and participate in an interview discussion.
• Over 18 years of age.
• Identified significant other provides informed consent to participate in the study.

Patient Exclusion Criteria for Interview Component of Study:

- Identified significant other refuses to participate or provide informed consent.

Significant Other Inclusion Criteria for Interview Component of Study:

• Nominated by the patient and willing to participate.
• Impacted or involved throughout the period of the patient's cardiovascular complication and recovery (e.g. familial relation, co-habitant, or close-relationship).
• Sufficient English language skills to understand and participate in an interview discussion.
• Over 18 years of age.
• Patient provides informed consent to participate in the study.

Significant Other Exclusion Criteria for Interview Component of Study:

- Patient refuses to participate or provide informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase-III Cardiac Rehabilitation; Eight weeks of supervised exercise sessions (one session per week).	Behavioral: Exercise-based cardiac rehabilitation; Moderate intensity aerobic exercise, lifestyle advice, and psychological support.
Phase-III and Phase IV Cardiac Rehabilitation; Twenty weeks of supervised exercise sessions (one session per week for first eight weeks [phase-III], session frequency determined by participant for remaining twelve weeks [phase-IV].	Behavioral: Exercise-based cardiac rehabilitation; Moderate intensity aerobic exercise, lifestyle advice, and psychological support.
No Cardiac Rehabilitation; Participants who declined to take part in a cardiac rehabilitation programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Sirtuin 1 serum protein concentration	Measured in ng/mL	At baseline and after 22-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6 serum protein concentration	Measured in pg/mL	Baseline, week-8, and week-22
Interleukin-10 serum protein concentration	Measured in pg/mL	Baseline, week-8, and week-22
Sirtuin 1 messenger ribonucleic acid gene expression		Baseline, week-8, and week-22
Interleukin-6 messenger ribonucleic acid gene expression		Baseline, week-8, and week-22
Interleukin-10 messenger ribonucleic acid gene expression		Baseline, week-8, and week-22
Erythrocyte sedimentation rate	Millimetres per hour	Baseline, week-8, and week-22
Serum low-density lipoprotein value		Baseline, week-8, and week-22
Serum total cholesterol value		Baseline, week-8, and week-22
Serum triglyceride value		Baseline, week-8, and week-22
Serum high-density lipoprotein value		Baseline, week-8, and week-22
Lipid soluble antioxidants concentrations		Baseline, week-8, and week-22
Lipid hydroperoxide concentration		Baseline, week-8, and week-22
Ascorbyl free radicle concentration		Baseline, week-8, and week-22
Brachial flow-mediated dilatation	Percentage increase in arterial diameter	Baseline, week-8, and week-22
Arterial stiffness (finger photo-plethysmography technique)	Stiffness index	Baseline, week-8, and week-22
Incremental Shuttle Walk Test	Distance walked (metres)	Baseline, week-8, and week-22
Systolic and diastolic blood pressure	Millimetre of mercury	Baseline, week-8, and week-22
Resting heart rate	Beats per minute	Baseline, week-8, and week-22
Body mass index	Kilograms per metre squared	Baseline, week-8, and week-22
Waist circumference	Centimetres	Baseline, week-8, and week-22

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative perspectives from study participants and their significant others regarding reasons for agreeing or declining to participate in a phase-III or phase-IV cardiac rehabilitation programme	Generated by semi-structured interviews	Week-8 or week-22

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Belfast Health and Social Care Trust; South Eastern Health and Social Care Trust
• Investigators: Study Director: Ciara Hughes, PhD, Ulster University; Study Chair: Gareth Thompson, PhD student, Ulster University; Study Chair: Gareth Davison, PhD, Ulster University; Study Chair: Jacqui Crawford, BSc, MSc, Ulster University; Principal Investigator: Lisa Spratt, Belfast Health and Social Care Trust; Principal Investigator: Maureen Morrison, South Eastern Health and Social Care Trust

Publications and helpful links

General Publications

• Thompson G, Wilson IM, Davison GW, Crawford J, Hughes CM. "Why would you not listen? It is like being given the winning lottery numbers and deciding not to take them": semi-structured interviews with post-acute myocardial infarction patients and their significant others exploring factors that influence participation in cardiac rehabilitation and long-term exercise training. Disabil Rehabil. 2022 Aug;44(17):4750-4760. doi: 10.1080/09638288.2021.1919213. Epub 2021 May 7.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Coronary Artery Disease; Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Arteriosclerosis
• Other Study ID Numbers: 18/0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No