Clinical trial NCT01775111: Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly
Official title: Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: strength training
protein supplementation
sarcopenia
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: Kaiser Franz Josef Hospital
First posted: 2013-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in isokinetic torque of knee extensors
timeFrame: baseline and 6 months
Secondary outcomes:
measure: change from baseline in 6min walking test
timeFrame: baseline and 6 months
measure: change from baseline in handgrip strength
timeFrame: baseline and 6 months
measure: change from baseline in single leg balance stand
timeFrame: baseline and 6 months
measure: change from baseline in lean body mass
timeFrame: baseline and 6 months
measure: change from baseline in muscular myostatin expression
timeFrame: baseline and 6 months
measure: change from baseline in DNA strand breaks
timeFrame: baseline and 6 months
measure: change from baseline in high-sensitive C reactive protein
timeFrame: baseline and 6 months
Other outcomes:
measure: change from baseline in isokinetic torque of knee extensors at 12 months
timeFrame: baseline and 12 months
measure: change from baseline in isokinetic torque of knee extensors at 18 months
timeFrame: baseline and 18 months
Locations:
city: Vienna
country: Austria
facility: University of Vienna, Centre of Sports Science and University Sports
Study officials:
affiliation: University of Vienna
name: Barbara Wessner, Ass.-Prof. DI Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.