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Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis (AIM)

Primary Purpose

Osteoarthritis, Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tailored Activity Pacing

General Activity Pacing

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Activity Pacing

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

VA Ann Arbor Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Tailored activity pacing

General activity pacing and symptom management (Occupational therapy)

Usual care group

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Pain- WOMAC

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

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.

Secondary Outcome Measures

Physical Function- Six Minute Walk

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

Physical Function- Six Minute Walk

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

Physical Function- Six Minute Walk

This is the distance people walk in feet over 6 minutes

Full Information

NCT ID

NCT01192516

First Posted

August 25, 2010

Last Updated

March 18, 2015

Sponsor

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT01192516

Brief Title

Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

Acronym

AIM

Official Title

Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Pain

Keywords

Osteoarthritis, Activity Pacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Tailored activity pacing

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

General activity pacing and symptom management (Occupational therapy)

Arm Title

Arm 3

Arm Type

No Intervention

Arm Description

Usual care group

Intervention Type

Behavioral

Intervention Name(s)

Tailored Activity Pacing

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

General Activity Pacing

Intervention Description

Therapeutic intervention using generalized pacing instruction to manage symptoms

Primary Outcome Measure Information:

Title

Fatigue- Brief Fatigue Inventory (BFI)

Description

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.

Time Frame

Baseline

Title

Fatigue-BFI

Description

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.

Time Frame

10 weeks post-baseline

Title

Fatigue-BFI

Description

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.

Time Frame

6 months post-baseline

Title

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

Description

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.

Time Frame

Baseline

Title

Pain- WOMAC

Description

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

Time Frame

10 weeks post-baseline

Title

Pain- WOMAC

Description

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

Time Frame

6 months post baseline

Secondary Outcome Measure Information:

Title

Physical Function- Six Minute Walk

Description

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

Time Frame

Baseline

Title

Physical Function- Six Minute Walk

Description

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

Time Frame

10 weeks post-baseline

Title

Physical Function- Six Minute Walk

Description

This is the distance people walk in feet over 6 minutes

Time Frame

6 months post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan L Murphy, ScD OTR

Organizational Affiliation

VA Ann Arbor Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Ann Arbor Healthcare System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48113

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27207435

Citation

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.

Results Reference

derived

PubMed Identifier

21810253

Citation

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.

Results Reference

derived

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Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

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