- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Vienna, Österrike, 1150
- Rekrytering
- University of Vienna, Centre of Sports Science and University Sports
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Kontakt:
- Barbara Wessner, Ass.-Prof. DI Dr.
- Telefonnummer: 28772 +4314277
- E-post: barbara.wessner@univie.ac.at
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Huvudutredare:
- Barbara Wessner, Ass.-Prof. DI Dr.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Sham Comparator: Cognitive Training
Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
change from baseline in isokinetic torque of knee extensors
Tidsram: baseline and 6 months
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baseline and 6 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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change from baseline in 6min walking test
Tidsram: baseline and 6 months
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baseline and 6 months
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change from baseline in handgrip strength
Tidsram: baseline and 6 months
|
baseline and 6 months
|
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change from baseline in single leg balance stand
Tidsram: baseline and 6 months
|
baseline and 6 months
|
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change from baseline in lean body mass
Tidsram: baseline and 6 months
|
baseline and 6 months
|
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change from baseline in muscular myostatin expression
Tidsram: baseline and 6 months
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baseline and 6 months
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change from baseline in DNA strand breaks
Tidsram: 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
Tidsram: baseline and 6 months
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baseline and 6 months
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Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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change from baseline in isokinetic torque of knee extensors at 12 months
Tidsram: 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
Tidsram: baseline and 18 months
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baseline and 18 months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Barbara Wessner, Ass.-Prof. DI Dr., University of Vienna
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ActiveAgeing
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