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

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ClinicalTrials.gov Identifier: NCT02078375
Recruitment Status : Suspended (Funding ended, waiting to secure additional sources)
First Posted : March 5, 2014
Last Update Posted : May 31, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
American College of Rheumatology Research and Education Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Protein Dietary Supplement: Carbohydrate (Placebo) Other: Resistance Exercise Program Not Applicable

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Placebo Comparator: Carbohydrate supplement
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)
The twice daily placebo will consist of a carbohydrate and a small amount of protein

Other: Resistance Exercise Program
All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program

Experimental: Protein Supplementation
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
whey protein plus casein protein
Other Name: whey protein plus casein protein

Other: Resistance Exercise Program
All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program




Primary Outcome Measures :
  1. Body composition [ Time Frame: after 16 weeks ]
    measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)

  2. Muscle strength [ Time Frame: after 16 weeks ]
    measured by hand grip and biodex



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02078375


Locations
United States, Maryland
Johns Hopkins Bayview Campus
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
American College of Rheumatology Research and Education Foundation
Investigators
Principal Investigator: Rebecca L. Manno, MD, MHS Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02078375     History of Changes
Other Study ID Numbers: NA_00088317
R03AG045081 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by Johns Hopkins University:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action