N/A
N=34
Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01307787 ↗Enrolled (actual)
34
Serious AEs
—
Results posted
May 2011
Primary outcome: Primary: Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness — 3.82; -0.44 ml/min/kg — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- experimental Fit-program (Other); no intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Center Groningen
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness |
3.82; -0.44 | 0.002 sig |
| SECONDARY Change in Self-efficacy Pain and Other Symptoms |
0.42; 0.28 | 0.47 |
| SECONDARY Change in Self-efficacy Function |
0.29; 0.10 | 0.24 |
| SECONDARY Change in Muscle Strength of the Upper Extremity |
36.06; -5.49 | 0.16 |
| SECONDARY Change in Muscle Strength of the Lower Extremity |
111.20; 25.61 | 0.21 |
| SECONDARY Change in Health Status: Physical Health |
-0.68; -0.14 | 0.07 |
| SECONDARY Change in Health Status: Psychological Health |
-0.34; 0.08 | 0.4 |
| SECONDARY Change in Health Status: Social Interaction |
-0.48; -0.88 | 0.6 |
Summary
The purpose of this study is to evaluate the effects of a group-based exercise and educational program for people with Rheumatoid Arthritis (RA) on physical performance and disease-self-management.
Eligibility Criteria
Inclusion Criteria
- medical diagnosis of RA according to the American College of Rheumatology (ACR) criteria
- between 18 and 66 years of age
Exclusion Criteria
- severe disease activity (Disease Activity Score: DAS-28 > 5.1)
- cardiac or pulmonary diseases resulting in restrictions in their ability to follow a physical exercise program
- a Steinbrocker classification of functional capacity in RA ≥ 3
- no stable medication for the RA
- intra-articular injections during the time of the study
Data sourced from ClinicalTrials.gov (NCT01307787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.