Clinical trial NCT05413616: The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Older Patients, Compared to Usual Care
Official title: The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Older Patients, Compared to Usual Care: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Old Age; Atrophy
Keywords: nutrition
protein
exercise
sarcopenia
older people
vitamin D
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance and is continued after discharge in the home care setting, supported by an e-health application.

Detailed description: Rationale: The older hospitalized population is growing and specifically at risk for decreased muscle mass and physical functioning and has a negative influence on activities of daily living, independence, quality of life, re-admissions, and nursing home placement. Current knowledge shows that a physical activity training programs consisting of tailored resistance and endurance exercise can improve muscle mass in healthy elderly. Nutritional interventions in conjunction with physical activity based on individual protein requirements, high quality protein and timing of protein intake can further stimulate muscle protein synthesis. The effect of a combined nutritional intervention with physical activity in healthy individuals and athletes has been studied before, but not in older hospitalized patients. A personalized combined physical activity program and a nutritional intervention could be a solution and is an exciting emerging field of research with the potential to dramatically improve patient outcomes.

The average hospital admittance is 4 to 5 days in which the prevention of the decline in muscle mass and physical performance can be initiated but not improved. Thus, the translation of a prolonged combined intervention to home care is essential. To support the combined personalized nutritional intervention and physical exercise intervention during hospitalization and home care, an eHealth application for and with older patients can be beneficial.

Objective: This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance, and is continued after discharge in the home care setting, supported by an e-health application.

Study design: The study will be performed as a randomized clinical trial. Study population: The study population hospitalized adult patients of ≥65 years, living in the Nijmegen area within the Radboud University Medical Centre.

Intervention: One group receives a personalized nutritional intervention by a dietician combines with a functional training program by physical therapists. The nutritional intervention focuses on adequate protein intake, type, and timing of protein. The exercise program will make use of goal setting throughout the intervention period to optimize the training effect . The control group will receive usual care.

Study parameters: The primary study outcome is based on the difference in change in physical performance between baseline and after 3 months of intervention of the intervention and the control group (usual care). This will be analyzed using multilevel mixed model corrected by potential confounders, measured by the Timed up \& Go test (TUG), a sensitive tool to measure physical performance in elderly.

Secondary: As a secondary outcome, the effect on short physical performance battery, muscle strength, muscle mass, nutritional status, movement, independence, quality of life, clinical outcomes and cost-effectiveness will be studied.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Study measurements are non-invasive. This study will not confer any no additional risks. The intervention will start at hospital admittance and will be continued after discharge in the home setting by a dietician and physiotherapist in their nearby home, which keeps the burden for the patient relatively low and is an extra service for the patient. Protein supplementation will be delivered within the save amounts. Possible serious reactions to the intervention will be noted as SAE's.

Eligibility criteria: Inclusion Criteria:

* Aged ≥65 years
* Living within the Nijmegen area (within 40km)
* Admitted to clinical ward of Radboudumc or CWZ
* Understanding and speaking of the Dutch language
* Mentally competent
* Signed informed consent

Exclusion Criteria:

* Complete use of tube feeding or parenteral nutrition
* Renal insufficiency (MDRD-GFR \< 30ml/min)

Primary outcomes:
measure: Change in Timed Up & Go
timeFrame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Secondary outcomes:
measure: Change in Short Physical Performance Battery
timeFrame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in muscle strength
timeFrame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in muscle mass
timeFrame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in nutritional status
timeFrame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in nutritional intake (energy, protein).
timeFrame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in movement according to actometer
timeFrame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in activities of daily living
timeFrame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
measure: Change in quality of life
timeFrame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
measure: Clinical outcomes: length of hospital stay
timeFrame: 24 weeks after baseline
measure: Clinical outcomes: re-admission
timeFrame: 24 weeks after baseline
measure: Clinical outcomes: complications
timeFrame: 24 weeks after baseline
measure: Clinical outcomes: mortality
timeFrame: 24 weeks after baseline
measure: Medical consumption
timeFrame: Baseline
measure: Medical consumption
timeFrame: 12 weeks after baseline, 24 weeks after baseline
measure: Risk for Sarcopenia
timeFrame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Sabien van Exter
state: Gelderland
Study officials:
References: