- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775111
Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Quittan, Prim. Univ.Prof. Dr.
- Phone Number: 3401 +43160191
- Email: michael.quittan@wienkav.at
Study Contact Backup
- Name: Barbara Wessner, Ass.-Prof. DI Dr.
- Phone Number: 28772 +4314277
- Email: barbara.wessner@univie.ac.at
Study Locations
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Vienna, Austria, 1150
- Recruiting
- University of Vienna, Centre of Sports Science and University Sports
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Contact:
- Barbara Wessner, Ass.-Prof. DI Dr.
- Phone Number: 28772 +4314277
- Email: barbara.wessner@univie.ac.at
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Principal Investigator:
- Barbara Wessner, Ass.-Prof. DI Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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.
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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.
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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
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baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in 6min walking test
Time Frame: baseline and 6 months
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baseline and 6 months
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change from baseline in handgrip strength
Time Frame: baseline and 6 months
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baseline and 6 months
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change from baseline in single leg balance stand
Time Frame: baseline and 6 months
|
baseline and 6 months
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change from baseline in lean body mass
Time Frame: baseline and 6 months
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baseline and 6 months
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change from baseline in muscular myostatin expression
Time Frame: baseline and 6 months
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baseline and 6 months
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change from baseline in DNA strand breaks
Time Frame: baseline and 6 months
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baseline and 6 months
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change from baseline in high-sensitive C reactive protein
Time Frame: baseline and 6 months
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baseline and 6 months
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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
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baseline and 12 months
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change from baseline in isokinetic torque of knee extensors at 18 months
Time Frame: baseline and 18 months
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baseline and 18 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara Wessner, Ass.-Prof. DI Dr., University of Vienna
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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