A High-PRotein Mediterranean Diet and Resistance Exercise for Cardiac Rehabilitation

NCT04272073 | Unknown

• 2 other identifiers: 19LJMUSPONSOR0092256927
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease is responsible for a quarter of all deaths in the UK and risk seems to be higher in cardiac rehabilitation (CR) with lower body weight which may be due to sarcopenci obesity (SO) or low muscle mass with high fat mass. The investigators aim to investigate the effect of a high protein Mediterranean diet and resistance exercise on improving lean mass and reducing risk markers of cardiovascular disease

Conditions

Cardiovascular Diseases; Sarcopenic Obesity

Keywords

sarcopenia; obesity; sarcopenic obesity; body composition; cardiac rehabilitation; cardiovascular disease; metabolic syndrome

Outcome Measures

Primary Outcomes (5)

• Feasability of recruitment

  Recruitment numbers over time course of study

  10 months

• Follow up rates

  Number of participants that respond to follow up questionnaires

  18 months

• Acceptability of dietary intervention

  Qualitative data from focus groups

  18 months

• Acceptability of exercise intervention

  Qualitative data from focus groups

  18 months

• Adherence to exercise protocol

  Number of exercise sessions actually attended out of number of prescribed sessions

  12 weeks

Secondary Outcomes (22)

• Change in appendicular skeletal muscle mass (DXA)

  12 weeks

• Change in muscle mass (DXA)

  12 weeks

• Change in muscle mass (BIA)

  12 weeks

• Change in fat mass (BIA)

  12 weeks

• Change in visceral fat mass (DXA)

  12 weeks

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Participants will perform standard cardiac rehabilitation involving weekly (1-3 days) aerobic-focused exercise sessions in community gyms. Participants will have received guidance on weight management and healthy eating from cardiac rehabilitation staff but will not receive any further dietary support.

Other: Standard Dietary Advice; Other: Standard Cardiac Rehabilitation Exercise

High-Protein mediterranean Diet and Resistance Exercise

EXPERIMENTAL

Participants will be asked to perform resistance exercise. This involves weights or weight machines aimed at building muscle strength. Participants will be required to attend 3 sessions per week and each session is expected to last approximately 45 minutes. Personalised dietary advice: we will ask participants to make changes to their diet to adapt it to a high-protein, Mediterranean-style diet * eating more fruit and vegetables, * reducing commercial pastries, and replacing refined carbohydrate foods (white bread, white rice, white pasta) by wholegrains (wholegrain bread, rice and pasta), * replacing butter and margarine by olive oil as the main culinary fat, * reducing fatty meat and replacing by lean meat, fish, and legumes (peas, beans, lentils), and by high-protein, low fat foods, such as low-fat dairy (participants will be provided with 2 dairy-based protein shakes to consume each day).

Other: High-Protein Mediterranean Diet; Other: Resistance Exercise

Interventions

High-Protein Mediterranean Diet OTHER

As in arm/group descriptions

High-Protein mediterranean Diet and Resistance Exercise

Resistance Exercise OTHER

As in arm/group descriptions

High-Protein mediterranean Diet and Resistance Exercise

Standard Dietary Advice OTHER

As in arm/group descriptions

Standard Care

Standard Cardiac Rehabilitation Exercise OTHER

As in arm/group descriptions

Standard Care

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent given
• Referral to cardiac rehabilitation program
• Ability to attend screening at Liverpool John Moores University
• Stage 2:
• Informed consent given
• Meeting selected criteria to define sarcopenic obesity (dependent on analysis from stage 1)
• Ability to attend screening at Liverpool John Moores University
• Cardiac function deemed stable after phase 3 cardiac rehabilitation

You may not qualify if:

• Inability to perform resistance exercise (determined by primary care team)
• Renal dysfunction
• Inability/unwillingness to digest/consume dairy products
• Admission to CR due to congenital or drug/alcohol-abuse induced cardiac events
• Pregnancy

Sponsors & Collaborators

• Liverpool John Moores University: lead
• University of Chester: collaborator

Study Sites (1)

Knowsley Community Cardiovascular Services

Liverpool, United Kingdom

Location

Related Publications (1)

• McCullough D, Kirwan R, Butler T, Perez de Heredia F, Thijssen D, Lip GYH, Mills J, Davies IG. 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. Clin Nutr ESPEN. 2021 Oct;45:492-498. doi: 10.1016/j.clnesp.2021.08.001. Epub 2021 Aug 15.

  PMID: 34620360 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Sarcopenia; Obesity; Metabolic Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fatima Perez de Heredia Benedicte, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate researcher

Model Details: A single-centre, cross-sectional analysis of the prevalence of SO in CR patients followed by a single-centre, 2x2 factorial, open label controlled trial

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: May 9, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

GB (1)