An interventional study of FITFOOD lifestyle intervention in Old Age; Atrophy, sponsored by Radboud University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
125 studies on the registry are indexed under Atrophy; 21 are open to participants now.
This study's planned enrollment of 136 is above the median of 36 across 104 interventional studies indexed under Atrophy.
Browse Atrophy studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Atrophy, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lifestyle intervention consisting of both a nutritional and exercise intervention.
Behavioral: FITFOOD lifestyle intervention
Lifestyle intervention with a nutritional and exercise component.
Change in Timed Up & Go
TUG
Time frame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
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).
Time frame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Change in muscle strength
Handgrip strength
Time frame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Change in muscle mass
BIA
Time frame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
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)
Time frame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Change in nutritional intake (energy, protein).
Food diary.
Time frame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Change in movement according to actometer
Activ8 measurement will assess movement during 1 week for each measurement point
Time frame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
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.
Time frame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
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.
Time frame: Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Clinical outcomes: length of hospital stay
Length of hospital stay
Time frame: 24 weeks after baseline
Clinical outcomes: re-admission
Re-admission
Time frame: 24 weeks after baseline
Clinical outcomes: complications
Complications
Time frame: 24 weeks after baseline
Clinical outcomes: mortality
Mortality
Time frame: 24 weeks after baseline
Medical consumption
iMCQ: iMTA Medical Consumption Questionnaire. Medical consumption will be measured using iMCQ and costs are calculated using Dutch reference values.
Time frame: Baseline
Medical consumption
iMCQ: iMTA Medical Consumption Questionnaire. Medical consumption will be measured using iMCQ and costs are calculated using Dutch reference values.
Time frame: 12 weeks after baseline, 24 weeks after baseline
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
Time frame: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Plan to share: Undecided
Started Jul 2022 (actual). Primary completion is estimated for Nov 2026, 51 months after the start.
Of 43 non-industry interventional studies with no phase under Atrophy, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 51 months is above that.
Counting every sponsor, half of 49 studies reached it within 14 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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