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

Old Age; Atrophy Clinical Trial

— FITFOOD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05413616
• Other study ID #: 2020-6664
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: January 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Old Age; Atrophy

Intervention

Behavioral:
• FITFOOD lifestyle intervention
Lifestyle intervention with a nutritional and exercise component.

Locations

Country	Name	City	State
Netherlands	Sabien van Exter	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Timed Up & Go	TUG	Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in Short Physical Performance Battery	Short Physical Performance Battery (scale: 0-12, a high score indicates no disability, a low score means disabilities may be present or developing).	Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in muscle strength	Handgrip strength	Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in muscle mass	BIA	Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in nutritional status	Patient-Generated Subjective Global Assessment (PG-SGA). Scale: 0-49 (low score: no intervention needed. Score>9: serious indication for intervention)	Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in nutritional intake (energy, protein).	Food diary.	Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in movement according to actometer	Activ8 measurement will assess movement during 1 week for each measurement point	Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in activities of daily living	LLFDI-CAT (Late-Life Function and Disability Instrument Computer Adaptive Test). LLFDI-CAT scores are transformed to a scale with mean = 50 and standard deviation =10.; Lower scores correspond to more limitation.	Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Change in quality of life	EQ-5D-5L (EuroQol 5-level five-dimensional questionnaire). Scores 1-5 where 1 is good and 5 indicates issues or problems.	Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Secondary	Clinical outcomes: length of hospital stay	Length of hospital stay	24 weeks after baseline
Secondary	Clinical outcomes: re-admission	Re-admission	24 weeks after baseline
Secondary	Clinical outcomes: complications	Complications	24 weeks after baseline
Secondary	Clinical outcomes: mortality	Mortality	24 weeks after baseline
Secondary	Medical consumption	iMCQ: iMTA Medical Consumption Questionnaire. Medical consumption will be measured using iMCQ and costs are calculated using Dutch reference values.	Baseline
Secondary	Medical consumption	iMCQ: iMTA Medical Consumption Questionnaire. Medical consumption will be measured using iMCQ and costs are calculated using Dutch reference values.	12 weeks after baseline, 24 weeks after baseline
Secondary	Risk for Sarcopenia	SARC-F: Strength, Assistance with walking, Rise from a chair, Climb stairs (scored 0-1-, higher score means higher risk for sarcopenia) and Falls	Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.