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Feasibility of a high-PRotein Mediterranean-style diet and resistance Exercise in cardiac Rehabilitation patients with sarcopenic obesity (PRiMER): Study protocol for a randomised control trial

McCullough, D, Kirwan, R, Butler, T, Pérez de Heredia, F, Thijssen, DHJ, Lip, GYH, Mills, J and Davies, IG (2021) Feasibility of a high-PRotein Mediterranean-style diet and resistance Exercise in cardiac Rehabilitation patients with sarcopenic obesity (PRiMER): Study protocol for a randomised control trial. Clinical Nutrition ESPEN. ISSN 2405-4577

Feasibility of a high-PRotein Mediterranean-style diet and resistanceExercise in cardiac Rehabilitation patients with sarcopenic obesity(PRiMER) Study protocol for a randomised control trial.pdf - Accepted Version
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Background Cardiac rehabilitation (CR) is an essential component of long-term recovery following a cardiac event. Typical CR may not be optimal for patients presenting with sarcopenic obesity (SO) who present with reduced muscle mass and elevated adipose tissue, and may indicate greater cardiovascular disease (CVD) risk. Resistance exercise and high-protein diets are known to increase muscle mass, while Mediterranean-style diets have been shown to reduce CVD risk. A high-protein Mediterranean-style diet combined with resistance exercise intervention is yet to be trialled in cardiac rehabilitation populations.
Objectives Primary outcome: to determine the feasibility of such an intervention by investigating the perceptions, acceptance and adherence to a resistance exercise protocol and high-protein Mediterranean style diet in a UK cardiac rehabilitation population with SO. Secondary outcome: to trial this protocol ahead of a fully powered clinical study.
Methods Eligible cardiac rehabilitation patients will be randomised to one of the following: 1) a control group (standard CR), 2) high-protein Mediterranean-style diet, 3) resistance exercise group, or 4) both high-protein Mediterranean-style diet and resistance exercise group. The pilot study will last 12 weeks. Measures of body composition (dual energy x-ray absorptiometry) grip strength, CVD risk (e.g., fasting triglycerides, glucose, cholesterol) and dietary adherence will be assessed at baseline and after 12 weeks. To compare groups, a mixed model ANOVA (time x intervention) will be performed. Patient participant involvement throughout the development of this project will be used to determine the feasibility of a future, fully powered, randomised control trial. A feasibility questionnaire will help establish the proportion of eligible participants, their willingness to be randomised, response rates, and ethical considerations. Furthermore, focus groups, food tasting and telephone interviews will be conducted to assess the acceptability of recipes and exercise protocols provided.
Discussion This pilot trial will determine whether a fully powered, multi-centred randomised control trial in CR patients with SO can be implemented. The information received from patient involvement will be invaluable for identifying possible barriers to participation and tailoring interventions to participant needs, helping to increase the likelihood of long-term compliance to health-promoting lifestyle changes.

Item Type: Article
Subjects: T Technology > TX Home economics > TX341 Nutrition. Foods and food supply
R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions: Biological & Environmental Sciences (from Sep 19)
Sport & Exercise Sciences
Publisher: Elsevier
Date Deposited: 02 Sep 2021 08:54
Last Modified: 15 Aug 2022 00:50
DOI or ID number: 10.1016/j.clnesp.2021.08.001
URI: https://researchonline.ljmu.ac.uk/id/eprint/15428
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