Clinical trial NCT04999358: Protein Intake in Patients With Coronary Heart Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Low Protein Intake
Sarcopenia
Keywords: Protein
Coronary heart disease
Rehabilitation
Telehealth
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
First posted: 2021-08-10
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single centre, parallel-group, two arm, randomised controlled trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in protein intake (g/kg/day).
timeFrame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary outcomes:
measure: Prevalence of low protein intake in patients with coronary heart disease.
timeFrame: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Change in sit to stand performance (leg strength).
timeFrame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Change in sarcopenia risk score and self-reported physical activity.
timeFrame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Difference in protein intake between patients with and without probable sarcopenia.
timeFrame: Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Change in waist circumference.
timeFrame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Reliability of self-assessed waist circumference.
timeFrame: 24 hours.
measure: Adherence
timeFrame: Up to 12 weeks.
measure: Attrition.
timeFrame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Occurrence of adverse events
timeFrame: Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
measure: Understanding and evaluation of the intervention.
timeFrame: Baseline and up to 12 weeks.
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Trust
Study officials:
affiliation: University of Northumbria at Newcastle
name: Alasdair O'Doherty, PhD
role: STUDY_CHAIR
References: