Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis (AIM)

March 18, 2015 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48113
        • VA Ann Arbor Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
10 weeks post-baseline
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.
6 months post-baseline
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.
Baseline
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.
10 weeks post-baseline
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.
6 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
Physical Function- Six Minute Walk
Time Frame: 10 weeks post-baseline
This is the distance in feet that people walk over 6 minutes.
10 weeks post-baseline
Physical Function- Six Minute Walk
Time Frame: 6 months post baseline
This is the distance people walk in feet over 6 minutes
6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Susan L Murphy, ScD OTR, VA Ann Arbor Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (ESTIMATE)

September 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7557-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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