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

NCT ID: NCT01539200

Last Updated: 2014-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-01-31

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.

Detailed Description

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Conditions

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Improvement of Functionality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

JDR

Intervention Type DIETARY_SUPPLEMENT

Jacques-Delacroze Eurythmic training with placebo ONS

Oral Nutritional Supplement (ONS) and JDR

Group Type ACTIVE_COMPARATOR

ONS+JDR

Intervention Type DIETARY_SUPPLEMENT

Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training

Interventions

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ONS+JDR

Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training

Intervention Type DIETARY_SUPPLEMENT

JDR

Jacques-Delacroze Eurythmic training with placebo ONS

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reto W Kressig, MD

Role: PRINCIPAL_INVESTIGATOR

Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel

Locations

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Basel Mobility Center, Department of Acute Geriatrics

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 28775900 (View on PubMed)

Other Identifiers

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NUD1051

Identifier Type: -

Identifier Source: org_study_id

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