Rheumatoid ArthritisPRESSRANCT02078375
The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
A study testing Protein and Resistance Exercise Program in people with Rheumatoid Arthritis, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Protein and Resistance Exercise Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 60-95 years
- diagnosis of rheumatoid arthritis
- willing to participate in twice weekly exercise sessions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
About this study
Official title: 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).
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Protein, Carbohydrate (Placebo), Resistance Exercise Program
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Also called whey protein plus casein protein
whey protein plus casein protein
Carbohydrate (Placebo)Dietary supplement
The twice daily placebo will consist of a carbohydrate and a small amount of protein
Resistance Exercise ProgramOther
All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate supplement | Placebo comparator | Participants will be enrolled in a twice weekly resistance exercise program. They will receive a carbohydrate supplement to take twice daily (once after exercise). Receives: Dietary Supplement: Carbohydrate (Placebo); Other: Resistance Exercise Program |
| Protein Supplementation | Experimental | Participants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise). Receives: Dietary Supplement: Protein; Other: Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)
Measured: after 16 weeks
Muscle strength
measured by hand grip and biodex
Measured: after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), American College of Rheumatology Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Rebecca L. Manno, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078375
- Sponsor's protocol ID
- NA_00088317
- Other IDs
- R03AG045081
- Acronym
- PRESSRA
- Status last verified
- Apr 2019
- First submitted
- 3 Mar 2014
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02078375
- Acronym / sponsor ID
- PRESSRA / NA_00088317
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), American College of Rheumatology Research and Education Foundation
- Study start
- Feb 2014 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate supplement | Placebo comparator | Dietary Supplement: Carbohydrate (Placebo), Other: Resistance Exercise ProgramParticipants 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 | Experimental | Dietary Supplement: Protein, Other: Resistance Exercise ProgramParticipants will be enrolled in a twice weekly resistance exercise program. They will receive a twice daily protein supplement (once after exercise). |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60-95 years
- diagnosis of rheumatoid arthritis
- willing to participate in twice weekly exercise sessions
Key exclusion criteria (7 listed)
- cognitive impairment
- recent heart surgery (within past 12 months)
- severe kidney disease
- use of supplemental oxygen
- presence of pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteinAlso: whey protein plus casein proteinwhey protein plus casein protein | Dietary supplement | Protein Supplementation |
| Carbohydrate (Placebo)The twice daily placebo will consist of a carbohydrate and a small amount of protein | Dietary supplement | Carbohydrate supplement |
| Resistance Exercise ProgramAll participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program | Other | Carbohydrate supplement, Protein Supplementation |
Primary outcome
Body composition
Time frame: after 16 weeks
measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)
Muscle strength
Time frame: after 16 weeks
measured by hand grip and biodex
Results and safety
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca L. Manno, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and Resistance Exercise Program in people with Rheumatoid Arthritis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: after 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019; AzTrials last refreshed its copy on 2 Nov 2026.