Effects of Daily Nutritional Supplementation in Combination With a Eurhythmics Training (NUDAL)

Study Overview
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Brief Summary
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Malnutrition and lack of regular exercise are often found in older adults and have been identified as important risk factors for independence loss and nursing home admission in older community-dwelling adults. Existing evidence suggests that high protein nutritional supplements can increase skeletal muscle protein synthesis following exercise in older individuals. However, increase of muscle strength by resistance training does not decrease the rate of falls and is not necessarily linked to an improvement of physical function. In contrast to resistance training, T'ai Chi, dance and eurhythmics have been shown to decrease fall incidence and improve mobility and physical function in older adults. The investigators will examine the combination of eurhythmics and high protein nutritional supplements. The aim of the study is to investigate whether there is an increase in normal walking velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze Eurhythmics training.

Official Title
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Effects of 6-months Once Daily Nutritional Supplementation in Combination With a Once Weekly Jacques-Delacroze Eurhythmics Training (NUDAL) on Functionality, Probability of Independence and/or Functional Reserve Among Community-dwelling Seniors

Conditions
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Improvement of Functionality

Intervention / Treatment
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* Dietary Supplement: ONS+JDR
* Dietary Supplement: JDR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling males and females, aged ≥ 65 years Able to walk unassisted for 15 meters MMSE ≥ 24 points Having obtained his/her informed consent Exclusion Criteria: Serum 25(OH) Vitamin D > 100 nmol/L from the blood sampling at Screening Current regular (defined as >3x /week) use of high protein oral nutritional supplements Milk protein allergy (Lactose intolerance) Severe visual impairment (corrected near vision <0.2 in both eyes) Severe neurological, orthopaedic, rheumatologic or psychiatric illness causing inability to understand or follow task instructions or to walk 15 meters without assistance (if clinically questionable, final decision will be made by a senior physician) Terminal illness with life expectancy less than 12 months, as determined by a physician

Ages Eligible for Study
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Minimum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Dietary Supplement: JDR<br>* Jacques-Delacroze Eurythmic training with placebo ONS<br>|
| Active Comparator: Oral Nutritional Supplement (ONS) and JDR<br> | Dietary Supplement: ONS+JDR<br>* Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal walking velocity | The primary objective is to demonstrate in older adults receiving a once weekly Jacques-Delacroze Eurhythmics (JDR) training for six months, that a once daily nutritional supplementation increases normal walking velocity compared with placebo. The primary endpoint of this study is normal walking velocity (NW velocity, in cm/s) six months after the onset of the treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life and Nutritional status | The secondary objectives of the research project are to compare the effects of the NUDAL intervention versus JDR alone, on changes in functional measures, nutritional status and health-related quality of life | baseline, 3 months, 6 months | 
| Normal walking velocity | Normal walking velocity (NW velocity, in cm/s) will also be evaluated three months after the onset of treatment as a secondary outcome | 3 months |