Protein Intake in Patients With Coronary Heart Disease

Sarcopenia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999358
• Other study ID #: 296288
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Northumbria University
• Contact: Emily James
• Phone: 07849425535
• Email: ejcj1[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Sarcopenia

Intervention

Behavioral:
• Protein education
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
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.

Locations

Country	Name	City	State
United Kingdom	Newcastle upon Tyne Hospitals NHS Trust	Newcastle Upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in protein intake (g/kg/day).	Between-group intervention effect for dietary protein intake in the intervention and control groups. Protein intake is assessed with a three-day food diary.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Prevalence of low protein intake in patients with coronary heart disease.	Average protein intake and percentage of participants with protein intake <1.2 g/kg/day and <0.8 g/kg/day.	Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Change in sit to stand performance (leg strength).	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.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Change in sarcopenia risk score and self-reported physical activity.	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.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Difference in protein intake between patients with and without probable sarcopenia.	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.	Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Change in waist circumference.	Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Reliability of self-assessed waist circumference.	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.	24 hours.
Secondary	Adherence	Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.	Up to 12 weeks.
Secondary	Attrition.	Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Occurrence of adverse events	Adverse events (such as injury or illness) that are directly related to the intervention will be reported..	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary	Understanding and evaluation of the intervention.	A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention	Baseline and up to 12 weeks.