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

Rheumatoid Arthritis Clinical Trial

— PRESSRA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02078375
• Other study ID #: NA_00088317
• Secondary ID: R03AG045081
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 1, 2018

Study information

• Verified date: April 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Protein
whey protein plus casein protein
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Campus	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	American College of Rheumatology Research and Education Foundation, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)	after 16 weeks
Primary	Muscle strength	measured by hand grip and biodex	after 16 weeks