Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly
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|ClinicalTrials.gov Identifier: NCT01775111|
Recruitment Status : Unknown
Verified January 2013 by Ass.-Prof. DI Dr. Barbara Wessner, University of Vienna.
Recruitment status was: Recruiting
First Posted : January 24, 2013
Last Update Posted : January 24, 2013
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 or disease||Intervention/treatment||Phase|
|Aging||Behavioral: Cognitive Training Behavioral: Strength Training Dietary Supplement: FortiFit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2013|
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|
- change from baseline in isokinetic torque of knee extensors [ Time Frame: baseline and 6 months ]
- change from baseline in 6min walking test [ Time Frame: baseline and 6 months ]
- change from baseline in handgrip strength [ Time Frame: baseline and 6 months ]
- change from baseline in single leg balance stand [ Time Frame: baseline and 6 months ]
- change from baseline in lean body mass [ Time Frame: baseline and 6 months ]
- change from baseline in muscular myostatin expression [ Time Frame: baseline and 6 months ]
- change from baseline in DNA strand breaks [ Time Frame: baseline and 6 months ]
- change from baseline in high-sensitive C reactive protein [ Time Frame: baseline and 6 months ]
- change from baseline in isokinetic torque of knee extensors at 12 months [ Time Frame: baseline and 12 months ]
- change from baseline in isokinetic torque of knee extensors at 18 months [ Time Frame: baseline and 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775111
|Contact: Michael Quittan, Prim. Univ.Prof. Dr.||+43160191 ext firstname.lastname@example.org|
|Contact: Barbara Wessner, Ass.-Prof. DI Dr.||+4314277 ext email@example.com|
|University of Vienna, Centre of Sports Science and University Sports||Recruiting|
|Vienna, Austria, 1150|
|Contact: Barbara Wessner, Ass.-Prof. DI Dr. +4314277 ext 28772 firstname.lastname@example.org|
|Principal Investigator: Barbara Wessner, Ass.-Prof. DI Dr.|
|Principal Investigator:||Barbara Wessner, Ass.-Prof. DI Dr.||University of Vienna|