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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05413616
Other study ID # 2020-6664
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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.
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