Clinical trial NCT01539200: Effects of Daily Nutritional Supplementation in Combination With a Eurhythmics Training (NUDAL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Improvement of Functionality
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Normal walking velocity
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life and Nutritional status
timeFrame: baseline, 3 months, 6 months
measure: Normal walking velocity
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Basel Mobility Center, Department of Acute Geriatrics
Study officials:
affiliation: Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel
name: Reto W Kressig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hardi I, Bridenbaugh SA, Cress ME, Kressig RW. Validity of the German Version of the Continuous-Scale Physical Functional Performance 10 Test. J Aging Res. 2017;2017:9575214. doi: 10.1155/2017/9575214. Epub 2017 Jul 9.