Completed

NCT Number: NCT01539200

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

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.

Completed

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Key information

Conditions

Improvement of Functionality

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Basel Mobility Center, Department of Acute Geriatrics

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONS+JDR

Dietary Supplement

Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training

JDR

Dietary Supplement

Jacques-Delacroze Eurythmic training with placebo ONS

Primary outcomes

Normal walking velocity

Time frame: 6 months

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.

Secondary outcomes

Quality of Life and Nutritional status

Time frame: baseline, 3 months, 6 months

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
Normal walking velocity

Time frame: 3 months

Normal walking velocity (NW velocity, in cm/s) will also be evaluated three months after the onset of treatment as a secondary outcome

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Acronym: NUDAL

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 27, 2012
Registry last updated: Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.