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

NCT01775111 | Unknown

• 1 other identifier: ActiveAgeing
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

strength training; protein supplementation; sarcopenia

Outcome Measures

Primary Outcomes (1)

• change from baseline in isokinetic torque of knee extensors

  baseline and 6 months

Secondary Outcomes (7)

• change from baseline in 6min walking test

  baseline and 6 months

• change from baseline in handgrip strength

  baseline and 6 months

• change from baseline in single leg balance stand

  baseline and 6 months

• change from baseline in lean body mass

  baseline and 6 months

• change from baseline in muscular myostatin expression

  baseline and 6 months

Other Outcomes (2)

• change from baseline in isokinetic torque of knee extensors at 12 months

  baseline and 12 months

• change from baseline in isokinetic torque of knee extensors at 18 months

  baseline and 18 months

Study Arms (3)

Cognitive Training

SHAM COMPARATOR

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

Behavioral: Cognitive Training

Strength Training

EXPERIMENTAL

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.

Behavioral: Strength Training

Strength Training and Supplement

EXPERIMENTAL

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.

Behavioral: Strength Training; Dietary Supplement: FortiFit

Interventions

Cognitive Training BEHAVIORAL

Cognitive Training

Strength Training BEHAVIORAL

Strength Training; Strength Training and Supplement

FortiFit DIETARY_SUPPLEMENT

Strength Training and Supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)
• or more points at the Short Physical Performance Battery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vienna: lead
• Kaiser Franz Josef Hospital: collaborator

Study Sites (1)

University of Vienna, Centre of Sports Science and University Sports

Vienna, Vienna, 1150, Austria

RECRUITING

Related Publications (3)

• 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.

  PMID: 29698742 DERIVED

• 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.

  PMID: 27905522 DERIVED

• 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.

  PMID: 26515246 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Cognitive Training; Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Exercise Therapy; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Barbara Wessner, Ass.-Prof. DI Dr.

  University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Quittan, Prim. Univ.Prof. Dr.

CONTACT

+43160191; michael.quittan@wienkav.at

Barbara Wessner, Ass.-Prof. DI Dr.

CONTACT

+4314277; barbara.wessner@univie.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof. DI Dr.

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

AU (1)