NCT01192516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 19, 2015

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2015

Enrollment Period

3.7 years

First QC Date

August 25, 2010

Results QC Date

February 13, 2015

Last Update Submit

March 18, 2015

Conditions

OsteoarthritisPain

Keywords

OsteoarthritisActivity Pacing

Outcome Measures

Primary Outcomes (6)

  • Fatigue- Brief Fatigue Inventory (BFI)

    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

    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

    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)

    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

    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

    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 Outcomes (3)

  • Physical Function- Six Minute Walk

    Baseline

  • Physical Function- Six Minute Walk

    10 weeks post-baseline

  • Physical Function- Six Minute Walk

    6 months post baseline

Study Arms (3)

Arm 1

EXPERIMENTAL

Tailored activity pacing

Behavioral: Tailored Activity Pacing

Arm 2

EXPERIMENTAL

General activity pacing and symptom management (Occupational therapy)

Behavioral: General Activity Pacing

Arm 3

NO INTERVENTION

Usual care group

Interventions

Tailored Activity PacingBEHAVIORAL

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

Arm 1
General Activity PacingBEHAVIORAL

Therapeutic intervention using generalized pacing instruction to manage symptoms

Arm 2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

Location

Related Publications (2)

  • 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.

    PMID: 27207435DERIVED

  • 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.

    PMID: 21810253DERIVED

MeSH Terms

Conditions

OsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Although overall effects were not found by group over time, additional data analyses will be conducted to determine if there were positive effects for specific subgroups of people.

Results Point of Contact

Title
Research Health Science Specialist
Organization
Veterans Affairs--Ann Arbor Health Care System
sumurphy@umich.edu
734-936-2123

Study Officials

  • Susan L Murphy, ScD OTR

    VA Ann Arbor Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

September 1, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 7, 2015

Results First Posted

March 19, 2015

Record last verified: 2015-03

Locations

US(1)