Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis (AIM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01192516
First received: August 25, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Pain
Behavioral: Tailored Activity Pacing
Behavioral: General Activity Pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fatigue- Brief Fatigue Inventory (BFI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue-BFI [ Time Frame: 10 weeks post-baseline ] [ Designated as safety issue: No ]
  • Fatigue-BFI [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
  • Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Pain- WOMAC [ Time Frame: 10 weeks post-baseline ] [ Designated as safety issue: No ]
  • Pain- WOMAC [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
  • Physical Function- Six minute walk [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Physical Function- Six minute walk [ Time Frame: 10 weeks post-baseline ] [ Designated as safety issue: No ]
  • Physical Function- Six Minute Walk [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: January 2010
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Tailored activity pacing
Behavioral: Tailored Activity Pacing
Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
Experimental: Arm 2
General activity pacing and symptom management (Occupational therapy)
Behavioral: General Activity Pacing
Therapeutic intervention using generalized pacing instruction to manage symptoms
No Intervention: Arm 3
Usual care group

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192516

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
Sponsors and Collaborators
Investigators
Principal Investigator: Susan L Murphy, ScD OTR VA Ann Arbor Healthcare System
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01192516     History of Changes
Other Study ID Numbers: E7557-R
Study First Received: August 25, 2010
Last Updated: September 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Osteoarthritis
Activity Pacing

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014