Improvement of Functionality Clinical Trial
— NUDALOfficial 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
| Verified date | March 2014 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | January 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Basel Mobility Center, Department of Acute Geriatrics | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |