NCT02078375

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

4.4 years

First QC Date

March 3, 2014

Last Update Submit

April 5, 2019

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Body composition

    measured by dual-energy X-ray absorptiometry (DEXA) (lean mass vs fat mass)

    after 16 weeks

  • Muscle strength

    measured by hand grip and biodex

    after 16 weeks

Study Arms (2)

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).

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).

Dietary Supplement: ProteinOther: Resistance Exercise Program

Interventions

ProteinDIETARY_SUPPLEMENT

whey protein plus casein protein

Also known as: whey protein plus casein protein
Protein Supplementation
Carbohydrate (Placebo)DIETARY_SUPPLEMENT

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

Carbohydrate supplement
Resistance Exercise ProgramOTHER

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

Carbohydrate supplementProtein Supplementation

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60-95 years
  • diagnosis of rheumatoid arthritis
  • willing to participate in twice weekly exercise sessions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ProteinsWhey ProteinsCarbohydrates

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rebecca L. Manno, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

US(1)