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

This study is currently recruiting participants.
Verified January 2013 by University of Vienna
Sponsor:
Collaborator:
Kaiser Franz Josef Hospital
Information provided by (Responsible Party):
Ass.-Prof. DI Dr. Barbara Wessner, University of Vienna
ClinicalTrials.gov Identifier:
NCT01775111
First received: January 21, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Aging
 Behavioral: Cognitive Training
Behavioral: Strength Training
Dietary Supplement: FortiFit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Vienna:

Primary Outcome Measures:
  • change from baseline in isokinetic torque of knee extensors [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in 6min walking test [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • change from baseline in handgrip strength [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • change from baseline in single leg balance stand [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • change from baseline in lean body mass [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • change from baseline in muscular myostatin expression [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • change from baseline in DNA strand breaks [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • change from baseline in high-sensitive C reactive protein [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • change from baseline in isokinetic torque of knee extensors at 12 months [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • change from baseline in isokinetic torque of knee extensors at 18 months [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Cognitive Training
Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups
 Behavioral: Cognitive Training
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.
 Behavioral: Strength Training
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.
 Behavioral: Strength Training Dietary Supplement: FortiFit

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775111

Contacts
Contact: Michael Quittan, Prim. Univ.Prof. Dr. +43160191 ext 3401 michael.quittan@wienkav.at
Contact: Barbara Wessner, Ass.-Prof. DI Dr. +4314277 ext 28772 barbara.wessner@univie.ac.at

Locations
Austria
University of Vienna, Centre of Sports Science and University Sports Recruiting
Vienna, Austria, 1150
Contact: Barbara Wessner, Ass.-Prof. DI Dr.     +4314277 ext 28772     barbara.wessner@univie.ac.at    
Principal Investigator: Barbara Wessner, Ass.-Prof. DI Dr.            
Sponsors and Collaborators
University of Vienna
Kaiser Franz Josef Hospital
Investigators
Principal Investigator: Barbara Wessner, Ass.-Prof. DI Dr. University of Vienna
  More Information

No publications provided

Responsible Party: Ass.-Prof. DI Dr. Barbara Wessner, Ass.Prof. DI Dr., University of Vienna
ClinicalTrials.gov Identifier: NCT01775111     History of Changes
Other Study ID Numbers: ActiveAgeing
Study First Received: January 21, 2013
Last Updated: January 21, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by University of Vienna:
strength training
protein supplementation
sarcopenia

ClinicalTrials.gov processed this record on May 16, 2013