N/A
Completed N=84
Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
Source: ClinicalTrials.gov NCT00383084 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Ambulatory Pain (Higher Values Indicate Greater Pain) — 54.6; 58.9; 46.3; 62.4 units on a scale
Summary
The purpose of this study is to determine the effect of 3 months of daily, 30-minute lifestyle physical activity on pain and fatigue in inactive adults with fibromyalgia (FM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ambulatory Pain (Higher Values Indicate Greater Pain) |
54.6; 58.9; 46.3; 62.4 | — |
| PRIMARY Ambulatory Fatigue, Higher Values Indicate Greater Fatigue |
51.9; 52.3; 50.6; 51.4 | — |
| SECONDARY Number of Tender Points on the Body |
16.2; 16.1; 16; 16.8 | — |
| SECONDARY Functional Capacity (Higher Scores Indicative of Poorer Functioning) |
67.5; 69.7; 56.7; 67 | — |
Eligibility Criteria
Inclusion Criteria
- Meets American College of Rheumatology (ACR) criteria for FM
- Inactive at study entry
- Willing to become more physically active
- Understands and willing to follow study recommendations regarding lifestyle modification
- Able to participate in the study for 2 years
- Agrees to not make any changes to current FM-related treatments
Exclusion Criteria
- Any comorbidity that may worsen a participant's physical functioning, independent of FM (e.g., significant cardiovascular disease, history of arrhythmias, morbid obesity, autoimmune diseases, uncontrolled or untreated hypertension, significant renal or prostate disease, stroke, seizure disorder, any other significant neurological diseases)
- Significant peripheral neuropathy
- Any current psychiatric disorder that involves a history of psychosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar disorder, or severe personality disorder. Participants with mood disorder are not excluded.
- Alcohol or substance abuse within the 2 years prior to study entry
- Current suicide risk or suicide attempt within the 2 years prior to study entry
- Severe physical disability that may interfere with physical activity
- Currently participates in structured exercise or plans to participate in an exercise program
- Any investigational medications or devices within 4 weeks prior to study entry
- Any expected life change, such as relocation, within the next 2 years that may prevent study participation
Data sourced from ClinicalTrials.gov (NCT00383084). 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. Informational only — not medical advice.