Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly

NCT ID: NCT01775111

Last Updated: 2013-01-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune system in elderly institutionalized persons.

The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener Pensionistenwohnheime). After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 intervention groups (cognitive training, strength training, strength training + supplement).

Study participants are eligible if they are male or female with an age over 65 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the medical training therapy, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.

Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters. The change in muscle signaling pathways will be assessed from muscle biopsies.

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cognitive Training

Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups

Group Type SHAM_COMPARATOR

Cognitive Training

Intervention Type BEHAVIORAL

Strength Training

Progressive strength training is applied, meaning that the intensity is adjusted continuously in order to obtain a sufficient training stimulus. Exercises are chosen to involve the major muscle groups and are performed by using the own body weight or elastic bands.

Group Type EXPERIMENTAL

Strength Training

Intervention Type BEHAVIORAL

Strength Training and Supplement

In addition to strength training as described above, participants receive a water-soluble dietary supplement 9x/week (FortiFit, Nutricia) consisting of 20.7 g of protein (56 En%, 19.7 g whey protein, 3 g leucine,\> 10 g essential amino acids), 9.3 g carbohydrates (25 En%, 0.8 BE), 3.0 g fat (18 En%), 1.2 g fiber (2 En%), 800 IU (20μg) of vitamin D, 250mg calcium, vitamins B6 and B12, folic acid and magnesium.

Group Type EXPERIMENTAL

Strength Training

Intervention Type BEHAVIORAL

FortiFit

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Cognitive Training

Intervention Type BEHAVIORAL

Strength Training

Intervention Type BEHAVIORAL

FortiFit

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State \>23)
* Ability to walk 10 meters independently (without orthopaedic devices)
* 4 or more points at the Short Physical Performance Battery

Exclusion Criteria

* Chronic diseases, which contraindicate a medical training therapy
* Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
* Diabetic retinopathy
* Manifest osteoporosis
* Regular use of cortisone-containing drugs
* Regular strength training (\> 1x / week) in the last 6 months before inclusion
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Franz Josef Hospital

OTHER

Sponsor Role collaborator

University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Ass.-Prof. DI Dr. Barbara Wessner

Ass.Prof. DI Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Wessner, Ass.-Prof. DI Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Locations

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University of Vienna, Centre of Sports Science and University Sports

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Michael Quittan, Prim. Univ.Prof. Dr.

Role: CONTACT

+43160191 ext. 3401

Barbara Wessner, Ass.-Prof. DI Dr.

Role: CONTACT

+4314277 ext. 28772

Facility Contacts

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Barbara Wessner, Ass.-Prof. DI Dr.

Role: primary

+4314277 ext. 28772

References

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Franzke B, Schober-Halper B, Hofmann M, Oesen S, Tosevska A, Henriksen T, Poulsen HE, Strasser EM, Wessner B, Wagner KH. Age and the effect of exercise, nutrition and cognitive training on oxidative stress - The Vienna Active Aging Study (VAAS), a randomized controlled trial. Free Radic Biol Med. 2018 Jun;121:69-77. doi: 10.1016/j.freeradbiomed.2018.04.565. Epub 2018 Apr 24.

Reference Type DERIVED
PMID: 29698742 (View on PubMed)

Tosevska A, Franzke B, Hofmann M, Vierheilig I, Schober-Halper B, Oesen S, Neubauer O, Wessner B, Wagner KH. Circulating cell-free DNA, telomere length and bilirubin in the Vienna Active Ageing Study: exploratory analysis of a randomized, controlled trial. Sci Rep. 2016 Dec 1;6:38084. doi: 10.1038/srep38084.

Reference Type DERIVED
PMID: 27905522 (View on PubMed)

Grimpampi E, Oesen S, Halper B, Hofmann M, Wessner B, Mazza C. Reliability of gait variability assessment in older individuals during a six-minute walk test. J Biomech. 2015 Nov 26;48(15):4185-4189. doi: 10.1016/j.jbiomech.2015.10.008. Epub 2015 Oct 20.

Reference Type DERIVED
PMID: 26515246 (View on PubMed)

Other Identifiers

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ActiveAgeing

Identifier Type: -

Identifier Source: org_study_id

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