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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein
Carbohydrate (Placebo)
Resistance Exercise Program
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Carbohydrate supplement

Protein Supplementation

Arm Description

Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise).

Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise).

Outcomes

Primary Outcome Measures

Body composition
measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)
Muscle strength
measured by hand grip and biodex

Secondary Outcome Measures

Full Information

First Posted
March 3, 2014
Last Updated
April 5, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA), American College of Rheumatology Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02078375
Brief Title
The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
Acronym
PRESSRA
Official Title
The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
February 2014 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA), American College of Rheumatology Research and Education Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate supplement
Arm Type
Placebo Comparator
Arm Description
Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise).
Arm Title
Protein Supplementation
Arm Type
Experimental
Arm Description
Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise).
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Other Intervention Name(s)
whey protein plus casein protein
Intervention Description
whey protein plus casein protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate (Placebo)
Intervention Description
The twice daily placebo will consist of a carbohydrate and a small amount of protein
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Program
Intervention Description
All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program
Primary Outcome Measure Information:
Title
Body composition
Description
measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)
Time Frame
after 16 weeks
Title
Muscle strength
Description
measured by hand grip and biodex
Time Frame
after 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L. Manno, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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