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Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis (AIM)

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Osteoarthritis
Pain

Treatments

Behavioral: Tailored Activity Pacing
Behavioral: General Activity Pacing

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01192516
E7557-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

195 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

195 participants in 3 patient groups

Arm 1
Experimental group
Description:
Tailored activity pacing
Treatment:
Behavioral: Tailored Activity Pacing
Arm 2
Experimental group
Description:
General activity pacing and symptom management (Occupational therapy)
Treatment:
Behavioral: General Activity Pacing
Arm 3
No Intervention group
Description:
Usual care group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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