Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

NCT ID: NCT01192516

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Osteoarthritis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Tailored activity pacing

Group Type: EXPERIMENTAL

Tailored Activity Pacing

Intervention Type: BEHAVIORAL

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

Arm 2

General activity pacing and symptom management (Occupational therapy)

Group Type: EXPERIMENTAL

General Activity Pacing

Intervention Type: BEHAVIORAL

Therapeutic intervention using generalized pacing instruction to manage symptoms

Arm 3

Usual care group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tailored Activity Pacing

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

Intervention Type: BEHAVIORAL

General Activity Pacing

Therapeutic intervention using generalized pacing instruction to manage symptoms

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan L Murphy, ScD OTR

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System

Locations

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27207435 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21810253 (View on PubMed)

Other Identifiers

E7557-R

Identifier Type: -

Identifier Source: org_study_id