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

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: Carbohydrate (Placebo); Dietary Supplement: Protein; Other: Resistance Exercise Program

• Registration Number: NCT02078375
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate supplement	Resistance Exercise Program	Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise).
Carbohydrate supplement	Carbohydrate (Placebo)	Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise).
Protein Supplementation	Protein	Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise).
Protein Supplementation	Resistance Exercise Program	Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise).

Primary Outcome Measures

Name	Time	Method
Body composition	after 16 weeks	measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)
Muscle strength	after 16 weeks	measured by hand grip and biodex

Trial Locations

Locations (1)

Johns Hopkins Bayview Campus; 🇺🇸 Baltimore, Maryland, United States