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STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)

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ClinicalTrials.gov Identifier: NCT02653768
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Knee osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among Veterans. Although exercise is known to improve pain, physical abilities, and other outcomes for patients who have knee OA, most individuals with this condition are physically inactive. Therefore there is a need to develop programs that will help Veterans and others with knee OA to increase activity levels. This study will examine a stepped approach to helping Veterans with knee OA to increase physical activity, with increasing levels of program intensity when needed for individual patients to meaningfully improve pain and physical function.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Behavioral: Stepped Exercise Program Behavioral: Arthritis Education Not Applicable

Detailed Description:

Knee osteoarthritis (OA) is a leading cause of pain and disability among Veterans, and Department of Veterans Affairs health care users are the most severely affected. There is ample evidence that exercise improves pain, function, and other outcomes among patients with knee OA. However, the vast majority of individuals with knee OA are physically inactive. There is clearly a need to develop and implement programs that efficiently and effectively foster regular physical activity and improve key patient-centered outcomes among Veterans with knee OA. This objective of this study is to evaluate the effectiveness a novel STepped Exercise Program for Knee OsteoArthritis (STEP-KOA).

This will be a randomized controlled trial of n=345 Veterans with symptomatic knee OA in two VA Integrated Networks (VISN) 6 sites, with participants assigned to two study arms: STEP-KOA and Arthritis Education Control (AE). STEP-KOA will begin with three months of access to a low-resource internet-based exercise training program that uses patient-specific information to determine and deliver an appropriate personalized exercise plan (Step 1). Participants who do not meet response criteria for clinically meaningful improvement in pain and function after three months of Step 1 will additionally receive telephone calls from an exercise counselor for three months, to facilitate adherence and address barriers to physical activity (Step 2). Participants who still fail to meet response criteria after Step 2 will receive in-person physical therapy visits, which address specific functional impairments and further tailor exercise recommendations (Step 3). Outcomes will be assessed at baseline, 3-months, 6-months, and 9 months (primary outcome time point). Veterans in the AE group will be offered participation in STEP-KOA after completing study assessments. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), a measure of lower extremity pain, stiffness and function. The secondary outcomes will be objective measures of physical function. The main study analyses will compare the STEP-KOA intervention to the AE control condition at follow-up time points. The investigators will also evaluate patient characteristics associated with the need for progression to each Step and will conduct a cost-effectiveness analysis of STEP-KOA. This stepped exercise intervention is matched with patient needs, and it also provides the VA with a potential approach for focusing limited physical therapy resources toward patients who do not respond adequately to initial, less resource intensive and costly strategies to improve physical activity and related outcomes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STEP-KOA
This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.
Behavioral: Stepped Exercise Program

STEP 1: Participants have access to an internet-based exercise program for knee OA.

STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.

STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit

Other Name: STEP-KOA

Active Comparator: Arthritis Education (AE)
Participants in the AE control group will receive low literacy educational materials via mail every two weeks. Because STEP-KOA is a multi-component intervention, with participants receiving different numbers of Steps, it is not possible to implement a control condition that will mirror the exact intervention "dose" received by all participants in the STEP-KOA group. However, AE will achieve the goal of providing an active, OA-related control condition.
Behavioral: Arthritis Education
The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to OA and its management, based on established treatment guidelines.
Other Name: AE




Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index -modified short form (mSF-WOMAC) [ Time Frame: Change from baseline to 3-month, 6-month, 9-month, and 15-month follow-ups ]
    This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms).


Secondary Outcome Measures :
  1. Objective Physical Function [ Time Frame: Change from baseline to 9-month follow-up ]
    These tests will include a 30 second stair stand test and a 40m fast-paced walk, following previously established procedures for each. The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. The 40m fast-paced walk is a timed test of walking twice back and forth (as fast as participants are able) over a 10m distance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran enrolled at the Durham VA Medical Center (VAMC)
  • Physician diagnosis of knee osteoarthritis
  • Current knee joint symptoms

Exclusion Criteria:

  • Currently meeting physical activity guidelines
  • Currently completing Physical Therapy (PT) visits for knee OA
  • Gout (in knee)
  • Rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
  • Dementia
  • Psychosis
  • Active substance abuse disorder
  • Meniscus or anterior cruciate ligament (ACL) tear in the past 6 months
  • Total joint replacement, other major lower extremity surgery in the past 6 months or planned in the next 9 months
  • Severe hearing impairment
  • Serious/terminal illness
  • Other health problem that would prohibit participation in the study and/or warrant immediate PT
  • Current participation in another OA intervention study
  • Unstable angina
  • History of ventricular tachycardia
  • Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
  • Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg)
  • Stroke with moderate to severe aphasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653768


Contacts
Contact: Kelli D Allen, PhD (919) 286-6936 kelli.allen@va.gov
Contact: Battista Smith, MPH BS (919) 286-0411 ext 4046 battista.smith@va.gov

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Kelli D Allen, PhD    (919) 286-6936    kelli.allen@va.gov   
Sub-Investigator: Courtney H Van Houtven, PhD         
Sub-Investigator: Cynthia J Coffman, PhD         
Sub-Investigator: Dennis Bongiorni, DPT         
Sub-Investigator: Helen Hoenig, MD         
Sub-Investigator: James C. Byrd, MD MPH         
Sub-Investigator: Katherine Shepherd Hall, PhD         
Principal Investigator: Kelli Dominick Allen, PhD         
Sub-Investigator: Kim Huffman, MD         
Sub-Investigator: Miriam C. Morey, PhD         
Sub-Investigator: Nancy Jo Hodges, DPT         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kelli Dominick Allen, PhD Durham VA Medical Center, Durham, NC

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02653768     History of Changes
Other Study ID Numbers: IIR 14-091
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Osteoarthritis, Knee
Exercise

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases