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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Old Age; Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

FITFOOD lifestyle intervention

Lifestyle intervention consisting of both a nutritional and exercise intervention.

Group Type EXPERIMENTAL

FITFOOD lifestyle intervention

Intervention Type BEHAVIORAL

Lifestyle intervention with a nutritional and exercise component.

Interventions

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FITFOOD lifestyle intervention

Lifestyle intervention with a nutritional and exercise component.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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