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Completed

NCT Number: NCT01192516

Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tailored Activity Pacing

Behavioral

Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.

General Activity Pacing

Behavioral

Therapeutic intervention using generalized pacing instruction to manage symptoms

Primary outcomes

  1. Fatigue- Brief Fatigue Inventory (BFI)

    Time frame: Baseline

    This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.

  2. Fatigue-BFI

    Time frame: 10 weeks post-baseline

    This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.

  3. Fatigue-BFI

    Time frame: 6 months post-baseline

    This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.

  4. Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline

    This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.

  5. Pain- WOMAC

    Time frame: 10 weeks post-baseline

    This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.

  6. Pain- WOMAC

    Time frame: 6 months post baseline

    This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.

Secondary outcomes

  1. Physical Function- Six Minute Walk

    Time frame: Baseline

    Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes

  2. Physical Function- Six Minute Walk

    Time frame: 10 weeks post-baseline

    This is the distance in feet that people walk over 6 minutes.

  3. Physical Function- Six Minute Walk

    Time frame: 6 months post baseline

    This is the distance people walk in feet over 6 minutes

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Acronym: AIM

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2010
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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