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

January 21, 2013 updated by: Ass.-Prof. DI Dr. Barbara Wessner, University of Vienna

Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Vienna, Austria, 1150
        • Recruiting
        • University of Vienna, Centre of Sports Science and University Sports
        • Contact:
        • Principal Investigator:
          • Barbara Wessner, Ass.-Prof. DI Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Cognitive Training
Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in isokinetic torque of knee extensors
Time Frame: baseline and 6 months
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in 6min walking test
Time Frame: baseline and 6 months
baseline and 6 months
change from baseline in handgrip strength
Time Frame: baseline and 6 months
baseline and 6 months
change from baseline in single leg balance stand
Time Frame: baseline and 6 months
baseline and 6 months
change from baseline in lean body mass
Time Frame: baseline and 6 months
baseline and 6 months
change from baseline in muscular myostatin expression
Time Frame: baseline and 6 months
baseline and 6 months
change from baseline in DNA strand breaks
Time Frame: baseline and 6 months
baseline and 6 months
change from baseline in high-sensitive C reactive protein
Time Frame: baseline and 6 months
baseline and 6 months

Other Outcome Measures

Outcome Measure
Time Frame
change from baseline in isokinetic torque of knee extensors at 12 months
Time Frame: baseline and 12 months
baseline and 12 months
change from baseline in isokinetic torque of knee extensors at 18 months
Time Frame: baseline and 18 months
baseline and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Barbara Wessner, Ass.-Prof. DI Dr., University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 21, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ActiveAgeing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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