N/A
Completed N=195
Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
Source: ClinicalTrials.gov NCT01192516 ↗Enrolled (actual)
195
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Fatigue- Brief Fatigue Inventory (BFI) — 3.06; 3.18; 2.70 units on a scale
Summary
The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups. A secondary objective is to evaluate the natural history of symptoms and physical disability over time among people with knee and hip osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue- Brief Fatigue Inventory (BFI) |
3.06; 3.18; 2.70 | — |
| PRIMARY Fatigue-BFI |
3.30; 2.90; 2.83 | .85 |
| PRIMARY Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
8.23; 8.19; 8.27 | — |
| PRIMARY Pain- WOMAC |
7.63; 7.33; 6.68 | .06 |
| SECONDARY Physical Function- Six Minute Walk |
1225.4; 1264.3; 1222.4 | .36 |
Eligibility Criteria
Inclusion Criteria
- Age of 50 years and older
- Reported pain for at least 3 months
- Mild-moderate pain severity according to the WOMAC pain scale
- Radiographic evidence of knee or hip osteoarthritis (Kellgren-Lawrence score of 2 in at least one joint)
- Community-dwelling (i.e. own home, apartment, senior residence)
- Ambulatory with or without a cane or walker
- Adequate cognition to complete study activities (score of 5 on the 6-Item Screener)
- Ability to use the Actiwatch-S (Phillips-Respironics, Mini-Mitter, Bend OR)accelerometer to record symptoms and activity patterns (ascertained by completion of a learning module specific to the use of the device in this study)
- English-speaking
Exclusion Criteria
- Self-reported medical history of conditions with pain and/or fatigue as a known and marked symptom (e.g multiple sclerosis, rheumatoid arthritis)
- Medically unstable (e.g. acute conditions or acute presentations of chronic conditions)
- Anemia (hemoglobin of 5.5 mg/dl)
- 2 or more days of complete bed rest within the last month
- Limb hemiplegia or amputation
- Arthroscopic procedure within the previous 2 months
- Joint injection within the previous 3 months
- Total or partial joint replacement within the previous 6 months
- Self-reported illness or conditions that impair cooperation with the study team or ability to complete study procedures
- Current enrollee in physical or occupational therapy for symptoms associated with osteoarthritis
- Current attendance or attendance within the previous year in a cognitive behavioral therapy program or other self-management program that includes activity pacing instruction
- Any other unforeseen exclusion criteria that, by the opinion of the study personnel, would make the participant unable to safely or effectively complete the study.
Data sourced from ClinicalTrials.gov (NCT01192516). 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.