The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Patients at Risk for Sarcopenia, Compared to Usual Care

Study Overview
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Brief Summary
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This project aims to improve physical performance in older patients who are at risk for sarcopenia, 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.

Detailed Description
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Rationale: The older hospitalized population is growing and specifically at risk for developing sarcopenia, which results in 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 at risk for sarcopenia. A personalized combined physical activity program and a nutritional intervention for patients at risk for sarcopenia 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 at risk for sarcopenia can be beneficial. Objective: This project aims to improve physical performance in older patients who are at risk for sarcopenia, 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 ≥50 years, living in the Nijmegen area at risk for sarcopenia according to SARC-F within the Radboud University Medical Center (RUMC) or Canisius Wilhelmina Hospital (CWZ). Intervention: One group receives a personalized nutritional intervention by a dietician combined 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 12 weeks of intervention of the intervention and the control group (usual care). This will be measured using the Timed Up and Go test, a sensitive tool to measure physical performance in elderly. Timed Up and Go data will be analyzed using regression analysis of covariance (ANCOVA). As secondary outcomes, the effect on short physical performance battery (gait speed, chair stand and balance test), 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 safe amounts. Possible serious reactions to the intervention will be noted as SAE's.

Official Title
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The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Patients at Risk for Sarcopenia, Compared to Usual Care: A Randomized Clinical Trial

Conditions
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Sarcopenia

Intervention / Treatment
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* Behavioral: FITFOOD lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥50 years Living within the Nijmegen area (within 40km) Risk for sarcopenia according to SARC-F 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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br> | |
| Experimental: FITFOOD lifestyle intervention<br>Lifestyle intervention consisting of both a nutritional and exercise intervention. | Behavioral: FITFOOD lifestyle intervention<br>* Lifestyle intervention with a nutritional and exercise component.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Change in muscle strength | Handgrip strength | Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline. | 
| Change in muscle mass | BIA | 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) | Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline. | 
| Change in nutritional intake (energy, protein, fluid, fiber, vitamin D, magnesium, selenium, omega-3 fatty acids). | Food diary. | 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 | 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. | 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. | Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline. | 
| Clinical outcomes | Length of hospital stay | 24 weeks after baseline | 
| Clinical outcomes | Re-admission | 24 weeks after baseline | 
| Clinical outcomes | Complications | 24 weeks after baseline | 
| Clinical outcomes | Mortality | 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. | Baseline | 
| 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 | 
| Medical consumption | iMCQ: iMTA Medical Consumption Questionnaire. Medical consumption will be measured using iMCQ and costs are calculated using Dutch reference values. | 24 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, protein, exercise, sarcopenia, elderly, vitamin D