Clinical trial NCT01192516: Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
Official title: Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Pain
Keywords: Osteoarthritis
Activity Pacing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-09-01
Enrollment: 195
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In the United States, osteoarthritis is a growing public health issue and a leading cause of disability among older adults. Almost 50% of users of the Veterans Affairs (VA) system present with osteoarthritis. Veterans are a particularly important group to target for symptom management interventions as they are twice as likely as non-veterans to report chronic joint symptoms and activity limitations. There are few evidence-based symptom management interventions offered by health care professionals, such as occupational and physical therapists, at the time when people are seeking treatment for their symptoms. The proposed activity pacing intervention is individually-tailored to a person's symptom and activity patterns. This tailoring provides a personally-relevant and focused intervention that may help people adopt this strategy into their daily lives.

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 \<10 for men and \<11 for women)
* Unmanaged thyroid dysfunction (Thyroid stimulating hormone \<.035\>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.

Primary outcomes:
measure: Fatigue- Brief Fatigue Inventory (BFI)
timeFrame: Baseline
measure: Fatigue-BFI
timeFrame: 10 weeks post-baseline
measure: Fatigue-BFI
timeFrame: 6 months post-baseline
measure: Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline
measure: Pain- WOMAC
timeFrame: 10 weeks post-baseline
measure: Pain- WOMAC
timeFrame: 6 months post baseline
Secondary outcomes:
measure: Physical Function- Six Minute Walk
timeFrame: Baseline
measure: Physical Function- Six Minute Walk
timeFrame: 10 weeks post-baseline
measure: Physical Function- Six Minute Walk
timeFrame: 6 months post baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System
name: Susan L Murphy, ScD OTR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy SL, Schepens Niemiec S, Lyden AK, Kratz AL. Pain, Fatigue, and Physical Activity in Osteoarthritis: The Moderating Effects of Pain- and Fatigue-Related Activity Interference. Arch Phys Med Rehabil. 2016 Sep;97(9 Suppl):S201-9. doi: 10.1016/j.apmr.2015.05.025. Epub 2016 May 17.
citation: Murphy SL, Lyden AK, Clary M, Geisser ME, Yung RL, Clauw DJ, Williams DA. Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans. BMC Musculoskelet Disord. 2011 Aug 2;12:177. doi: 10.1186/1471-2474-12-177.