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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Cognitive Training
* Behavioral: Strength Training
* Dietary Supplement: FortiFit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Cognitive Training<br>Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups | Behavioral: Cognitive Training<br> <br> |
| Experimental: Strength Training<br>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<br> <br> |
| Experimental: Strength Training and Supplement<br>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<br> <br> Dietary Supplement: FortiFit<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in isokinetic torque of knee extensors |  | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| change from baseline in DNA strand breaks |  | baseline and 6 months | 
| change from baseline in high-sensitive C reactive protein |  | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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strength training, protein supplementation, sarcopenia