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

April 5, 2019 updated by: Johns Hopkins University

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).
Other: Resistance Exercise Program
All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program
Dietary supplement: Protein
whey protein plus casein protein
Other Names:
  • whey protein plus casein protein

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)
American College of Rheumatology Research and Education Foundation

Investigators

  • Principal Investigator: Rebecca L. Manno, MD, MHS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00088317
  • R03AG045081 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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