The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study will evaluate if the combination of resistance exercise and protein supplementation will increase muscle strength and muscle mass among older individuals with rheumatoid arthritis (RA).

Detailed Description
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This study proposes a randomized trial to evaluate a tailored 16-week resistance exercise program, in combination with protein supplementation, for older individuals with RA. The exercise protocol in this study is distinctive because it combines dynamic and isometric (static) resistance exercise performed on specialized equipment that can accommodate the range of motion limitations frequently encountered in the older RA population. This study will also begin to evaluate if additional benefit can be achieved with daily protein supplementation

Official Title
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The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Dietary Supplement: Protein
* Dietary Supplement: Carbohydrate (Placebo)
* Other: Resistance Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 60-95 years diagnosis of rheumatoid arthritis willing to participate in twice weekly exercise sessions Exclusion Criteria: cognitive impairment recent heart surgery (within past 12 months) severe kidney disease use of supplemental oxygen presence of pacemaker diabetes that requires insulin for management allergy to soy or milk

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Carbohydrate supplement<br>Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise). | Dietary Supplement: Carbohydrate (Placebo)<br>* The twice daily placebo will consist of a carbohydrate and a small amount of protein<br>Other: Resistance Exercise Program<br>* All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program<br>|
| Experimental: Protein Supplementation<br>Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise). | Dietary Supplement: Protein<br>* whey protein plus casein protein<br>* Other names: whey protein plus casein protein;Other: Resistance Exercise Program<br>* All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass) | after 16 weeks | 
| Muscle strength | measured by hand grip and biodex | after 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis