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

NCT03907293 | Completed

• 1 other identifier: 18/0056
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Arteriosclerosis; Myocardial Infarction; Myocardial Ischemia

Keywords

Cardiac Rehabilitation; Exercise; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline Sirtuin 1 serum protein concentration

  Measured in ng/mL

  At baseline and after 22-weeks

Secondary Outcomes (20)

• Interleukin-6 serum protein concentration

  Baseline, week-8, and week-22

• Interleukin-10 serum protein concentration

  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

Other Outcomes (1)

• 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

  Week-8 or week-22

Study Arms (3)

Phase-III Cardiac Rehabilitation

Eight weeks of supervised exercise sessions (one session per week).

Behavioral: Exercise-based cardiac rehabilitation

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

No Cardiac Rehabilitation

Participants who declined to take part in a cardiac rehabilitation programme.

Interventions

Exercise-based cardiac rehabilitation BEHAVIORAL

Moderate intensity aerobic exercise, lifestyle advice, and psychological support.

Phase-III Cardiac Rehabilitation; Phase-III and Phase IV Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator
• South Eastern Health and Social Care Trust: collaborator

Study Sites (2)

Belfast Health and Social Care Trust (Belfast City Hospital, Mater Hospital, and Royal Victoria Hospital)

Belfast, Co. Antrim, BT9 7AB, United Kingdom

Location

South Eastern Health and Social Care Trust (Ulster Hospital)

Dundonald, Co. Down, BT16 1RH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33961501 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Whole blood Lymphocytes

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Study Officials

• Ciara Hughes, PhD

  Ulster University

  STUDY DIRECTOR

• Gareth Thompson, PhD student

  Ulster University

  STUDY CHAIR

• Gareth Davison, PhD

  Ulster University

  STUDY CHAIR

• Jacqui Crawford, BSc, MSc

  Ulster University

  STUDY CHAIR

• Lisa Spratt

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

• Maureen Morrison

  South Eastern Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 8, 2019
• Study Start: February 23, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

GB (2)