The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals

Study Overview
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Brief Summary
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The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.

Detailed Description
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Aging is accompanied by a loss of muscle mass and strength. Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline. The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function. The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail. Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest. Strategies to improve functional capacity in this population are therefore important. It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals. However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals. Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely. Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity. Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group. In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period. The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.

Official Title
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Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity

Conditions
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Aging

Intervention / Treatment
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* Other: Heavy-load strength training
* Dietary Supplement: Protein supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 75 Short Physical Performance Battery (SPPB) score ≤ 10 Exclusion Criteria: Lactose intolerance Milk allergy Diseases or musculoskeletal disorders contraindicating training/testing

Ages Eligible for Study
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Minimum Age: 75 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training + protein supplement<br>Heavy-load strength training, Protein supplementation | Other: Heavy-load strength training<br>* Three weekly sessions of heavy-load strength training for 10 weeks<br>* Other names: Resistance exercise;Dietary Supplement: Protein supplementation<br>* Daily supplementation of 2 x 17 grams of milk protein<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength of m. Quadriceps Femoris | Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors) | Change from baseline at 10 weks | 
| Muscle strength of m. quadriceps femoris | Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum) | Change from baseline at 10 weeks | 
| Leg lean mass | Measured by Dual-energy X-ray Absorptiometry (DXA-scan) | Change from baseline at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lean mass | Measured by Dual-energy X-ray Absorptiometry (DXA-scan) | Change from baseline at 10 weeks | 
| Fat mass | Measured by Dual-energy X-ray Absorptiometry (DXA-scan) | Change from baseline at 10 weeks | 
| Bone mineral density | Measured by Dual-energy X-ray Absorptiometry (DXA-scan) | Change from baseline at 10 weeks | 
| m. Vastus Lateralis thickness | Measured by ultrasound | Change from baseline at 10 weeks | 
| m. Rectus Femoris thickness | Measured by ultrasound | Change from baseline at 10 weeks | 
| m. Vastus Intermedius thickness | Measured by ultrasound | Change from baseline at 10 weeks | 
| m. Vastus Medialis thickness | Measured by ultrasound | Change from baseline at 10 weeks | 
| Isometric knee extension rate of force development (RFD max) | Measured during maximal voluntary contraction | Change from baseline at 10 weeks | 
| Isometric knee extension force at 100 ms | Force at 100 ms during maximal voluntary contraction | Change from baseline at 10 weeks | 
| Habitual gait velocity | Time (sec) to walk 6 meters at preferred gait speed | Change from baseline at 10 weeks | 
| Five times chair-rise performance | Time (sec) to rise from a chair five times | Change from baseline at 10 weeks | 
| Stair climbing | Time (sec) to climb a staircase | Change from baseline at 10 weeks | 
| Diet assessment | 24-hour diet recall interviews | Change from baseline at 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strength training, Pre-frail