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
FITFOOD
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedStudy Start
First participant enrolled
July 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 24, 2025
July 1, 2025
4.3 years
May 19, 2022
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Change in Short Physical Performance Battery
Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Change in muscle strength
Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Change in muscle mass
Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
Change in nutritional status
Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
Change in nutritional intake (energy, protein).
Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
- +10 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONFITFOOD lifestyle intervention
EXPERIMENTALLifestyle intervention consisting of both a nutritional and exercise intervention.
Interventions
Lifestyle intervention with a nutritional and exercise component.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Complete use of tube feeding or parenteral nutrition
- Renal insufficiency (MDRD-GFR \< 30ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sabien van Exter
Nijmegen, Gelderland, 6531DK, Netherlands
Related Publications (1)
van Exter SH, Koenders N, van der Wees PJ, Drenth JPH, van den Berg MGA. Lessons learned from a combined, personalized lifestyle intervention in hospitalized patients at risk for sarcopenia: a feasibility study. Disabil Rehabil. 2025 Jul;47(14):3679-3686. doi: 10.1080/09638288.2024.2426685. Epub 2024 Nov 12.
PMID: 39530465DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
June 10, 2022
Study Start
July 4, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
July 24, 2025
Record last verified: 2025-07