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Completed

NCT Number: NCT04999358

Protein Intake in Patients With Coronary Heart Disease

Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. However, in patients with coronary heart disease (CHD), this number is almost 3 in 10. Patients who have CHD are offered cardiac rehabilitation (CR); a multicomponent programme designed to improve long-term health outcomes. Nutritional education is an important part of CR and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. Currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. Eligible patients with CHD and low protein intake will receive the standard nutritional education delivered during CR. Next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). Whilst COVID-19 restrictions are in place, education will be delivered remotely via pre-recorded video. Outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified SARC-F), Physical Activity Vital Signs (PAVS) and waist circumference, will be assessed at baseline, at the end of the standard CR programme and after a follow-up period of the same duration as the CR programme.

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Key information

Conditions

Coronary Heart Disease Atrophy Cardiovascular Diseases Coronary Disease Heart Diseases Low Protein Intake Muscular Atrophy Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newcastle upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 50 years or older.
  • Recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease.
  • Have been offered standard cardiac rehabilitation in a Newcastle upon Tyne Hospitals NHS Foundation Trust.
  • Usually receive dietary education as part of their cardiac rehabilitation program.
  • Able to understand and undertake the tasks described as part of this study.
  • Able to provide written informed consent.

Exclusion criteria

  • Patients advised against participation in light exercise by a medical professional.
  • Patients younger than 50 years.
  • Patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets.
  • Patients with known stage 4 or 5 chronic kidney disease.
  • Patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.

Treatment and study plan

Protein education

Behavioral

The protein education session is pre-recorded and will describe in lay terms: the health issues associated with low protein intake, the amount of protein to eat in a day, and provide useful information to increase protein intake. This information will focus on the quality and amount of protein eaten, primarily using a whole-food approach. For example, the education sessions will give ideas for everyday foods that can be added to regular meals, favouring plant proteins, fish, lean meat, poultry, low fat dairy and eggs. The education session has been provided in conjunction with an NHS dietitian.

standard education

Behavioral

Dietary advice provided as part of standard cardiac rehabilitation will be pre-recorded and provided to the control group. This education session will be in addition to usual care.

Primary outcomes

  1. Change in protein intake (g/kg/day).

    Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Between-group intervention effect for dietary protein intake in the intervention and control groups. Protein intake is assessed with a three-day food diary.

Secondary outcomes

  1. Prevalence of low protein intake in patients with coronary heart disease.

    Time frame: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Average protein intake and percentage of participants with protein intake <1.2 g/kg/day and <0.8 g/kg/day.

  2. Change in sit to stand performance (leg strength).

    Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Between-group intervention effect for sit to stand performance in the intervention and control groups. The time taken to complete five consecutive sit to stands will be recorded.

  3. Change in sarcopenia risk score and self-reported physical activity.

    Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Between-group intervention effect for questionnaire scores in the intervention and control groups. Sarcopenia risk and physical activity are assessed using the modified SARC-F questionnaire (SARC-F+EBM; includes age and body mass index) and Physical Activity Vital Signs questionnaire (PAVS), respectively.

  4. Difference in protein intake between patients with and without probable sarcopenia.

    Time frame: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Probable sarcopenia is assessed using sit to stand time. The cut-off point for probable sarcopenia will be >15seconds to complete five sit to stands, as proposed by the European Working Group on Sarcopenia in Older People-2.

  5. Change in waist circumference.

    Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.

  6. Reliability of self-assessed waist circumference.

    Time frame: 24 hours.

    Whilst COVID-19 restrictions are in place, participants will be required to complete their own waist circumference measurement. Measures will be taken 24 hours apart to determine their reliability.

  7. Adherence

    Time frame: Up to 12 weeks.

    Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.

  8. Attrition.

    Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.

  9. Occurrence of adverse events

    Time frame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

    Adverse events (such as injury or illness) that are directly related to the intervention will be reported..

  10. Understanding and evaluation of the intervention.

    Time frame: Baseline and up to 12 weeks.

    A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

Registry information

Official study title

The Effectiveness of a Targeted Protein Education Telehealth Intervention to Increase Protein Intake in Patients With Coronary Heart Disease and Low Protein Intake: A Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2021
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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