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

Aging Clinical Trial

Official title:

Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01775111
• Other study ID #: ActiveAgeing
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2013
• Last updated: January 21, 2013
• Start date: January 2012

Study information

• Verified date: January 2013
• Source: University of Vienna
• Contact: Michael Quittan, Prim. Univ.Prof. Dr.
• Phone: +43160191
• Email: michael.quittan[@]wienkav.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Cognitive Training

• Strength Training

Dietary Supplement:
• FortiFit

Locations

Country	Name	City	State
Austria	University of Vienna, Centre of Sports Science and University Sports	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
University of Vienna	Kaiser Franz Josef Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline in isokinetic torque of knee extensors at 12 months		baseline and 12 months	No
Other	change from baseline in isokinetic torque of knee extensors at 18 months		baseline and 18 months	No
Primary	change from baseline in isokinetic torque of knee extensors		baseline and 6 months	No
Secondary	change from baseline in 6min walking test		baseline and 6 months	No
Secondary	change from baseline in handgrip strength		baseline and 6 months	No
Secondary	change from baseline in single leg balance stand		baseline and 6 months	No
Secondary	change from baseline in lean body mass		baseline and 6 months	No
Secondary	change from baseline in muscular myostatin expression		baseline and 6 months	No
Secondary	change from baseline in DNA strand breaks		baseline and 6 months	No
Secondary	change from baseline in high-sensitive C reactive protein		baseline and 6 months	No