NCT00327275

Brief Summary

To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life. We hypothesized that improvements would be seen in all of the above outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2004

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
Last Updated

May 18, 2006

Status Verified

May 1, 2006

First QC Date

May 16, 2006

Last Update Submit

May 16, 2006

Conditions

Outcome Measures

Primary Outcomes (4)

  • Strength

  • Body Composition

  • Function

  • Pain

Secondary Outcomes (3)

  • Quality of Life

  • Disease Activity

  • Fatigue

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females with RA
  • Over 18 years of age
  • ACR Functional Class I and II
  • Taking Remicade \>4 months

You may not qualify if:

  • Presence of comorbid conditions contraindicated to exercise, including, but not limited to:
  • heart disease
  • severe osteoporosis: (if \>50 years): T score \< -3.0 for hip or spine excluded; T score \<-2.5 for hip or spine w/o current treatment)
  • (all potential subjects) previous non-traumatic fractures
  • uncontrolled BP
  • BMI \>40
  • Regular use of assistive walking device which would interfere with ability to lift weights
  • Currently or within the last 3 months participating in aerobic exercise \> 150 minutes a week
  • Currently or within the last 3 months participating in any regular strength training activities
  • Presence of neurological impairment that directly limits ability to perform exercise
  • Participation in concurrent exercise study
  • Any reason for which the investigator deems it would not be in the patient's best interest to continue in the study
  • Plans to move away from site within next 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hilary G Flint-Wagner, PhD, MPH

    Idaho State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 18, 2006

Study Start

March 1, 2004

Study Completion

January 1, 2005

Last Updated

May 18, 2006

Record last verified: 2006-05

Locations