Effects of Daily Nutritional Supplementation in Combination With a Eurhythmics Training (NUDAL) (NUDAL)
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|ClinicalTrials.gov Identifier: NCT01539200|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : March 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Improvement of Functionality||Dietary Supplement: ONS+JDR Dietary Supplement: JDR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||March 2012|
|Primary Completion Date :||January 2014|
|Study Completion Date :||January 2014|
|Placebo Comparator: Control||
Dietary Supplement: JDR
Jacques-Delacroze Eurythmic training with placebo ONS
|Active Comparator: Oral Nutritional Supplement (ONS) and JDR||
Dietary Supplement: ONS+JDR
Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539200
|Basel Mobility Center, Department of Acute Geriatrics|
|Basel, Switzerland, 4031|
|Principal Investigator:||Reto W Kressig, MD||Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel|