The Effects of a 16-Week Individualized, Intensive Strength Training Program in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

The Strength Training and Remicade Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327275
• Other study ID #: 080192
• Status: Completed
• Phase: N/A
• First received: May 16, 2006
• Last updated: May 16, 2006
• Start date: March 2004
• Est. completion date: January 2005

Study information

• Verified date: May 2006
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females with RA

• Over 18 years of age

• ACR Functional Class I and II

• Taking Remicade >4 months

Exclusion Criteria:

• Presence of comorbid conditions contraindicated to exercise, including, but not limited to:

1. heart disease

2. 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)

3. (all potential subjects) previous non-traumatic fractures

4. 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• strength training

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength
Primary	Body Composition
Primary	Function
Primary	Pain
Secondary	Quality of Life
Secondary	Disease Activity
Secondary	Fatigue