Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men

Study Overview
=================
Brief Summary
-----------------
Investigate the effect of 12 weeks mixed power training (power and functional exercises) combined with a protein supplementation (30g/d) or not (placebo) on physiological characteristics of muscle and functional capacities in elderly men.

Detailed Description
-----------------
Life habits are know to be able to prevent the loss of functional capacities and muscle function during aging process. More specifically, protein intake is important to maintain muscle function in older adults. Another non pharmacological intervention and well recognized for its efficacy, it's exercise training. Recently, it has been observed than muscle quality is more important to maintain physical autonomy than muscle mass per se. In addition, muscle quality is more related to functional capacities than muscle mass. Due to this recent finding, it has been proposed that muscle power training would be the best exercise intervention to prevent the loss of mobility.

Official Title
-----------------
Effect of Protein Supplementation Combined With Mixed Power Training on Muscle Function, Composition, Phenotype and Functional Capacities Compared to Mixed Power Training Alone in Elderly Men

Conditions
-----------------
Dynapenia, Aging, Physical Impairment

Intervention / Treatment
-----------------
* Other: Exercise + Placebo group
* Other: Exercise + Protein group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly men 60 years and older Sedentary men Not obese (BMI <30 kg/m2) Living in free-living community Exclusion Criteria: Not able to follow an exercise program (doctor authorization: XAAP) Having Lactose intolerance Having Pace marker Having Metabolism disorder No weight stable since the last 6 months No stable medication (same dose and type since at least 6 months)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise + Placebo group<br>50 subjects will receive a placebo supplementation with an exercise intervention (EX group) | Other: Exercise + Placebo group<br>* 1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo<br>|
| Active Comparator: Exercise + Protein group<br>50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group) | Other: Exercise + Protein group<br>* 1/2 of the subject will receive 30 g/ d of protein (leucine+ vitD; divided in three equal doses: morning, afternoon and evening) + will follow a mixed power training: 4 power exercises + 6 functional exercises.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | evaluate using the 4m- normal walking speed (m/sec) | Change from Baseline walking speed at 12 weeks measure in all subjects | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lower limb muscle quality | Knee extension muscle strength (isometric (N)/ lower limb muscle mass (kg)) | Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, protein, muscle function, aging