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

NCT ID: NCT02078375

Last Updated: 2019-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-07-01

Brief Summary

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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

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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

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Carbohydrate (Placebo)

Intervention Type DIETARY_SUPPLEMENT

The twice daily placebo will consist of a carbohydrate and a small amount of protein

Resistance Exercise Program

Intervention Type OTHER

All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program

Protein Supplementation

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

Group Type EXPERIMENTAL

Protein

Intervention Type DIETARY_SUPPLEMENT

whey protein plus casein protein

Resistance Exercise Program

Intervention Type OTHER

All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program

Interventions

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Protein

whey protein plus casein protein

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate (Placebo)

The twice daily placebo will consist of a carbohydrate and a small amount of protein

Intervention Type DIETARY_SUPPLEMENT

Resistance Exercise Program

All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program

Intervention Type OTHER

Other Intervention Names

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whey protein plus casein protein

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

American College of Rheumatology Research and Education Foundation

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca L. Manno, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Campus

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R03AG045081

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00088317

Identifier Type: -

Identifier Source: org_study_id

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