Old Age; Atrophy Clinical Trial
— FITFOODOfficial 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
Verified date | November 2023 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Sabien van Exter | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
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. |
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