STepped Exercise Program for Knee OsteoArthritis

NCT02653768 | Completed Results

• 1 other identifier: IIR 14-091
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Exercise

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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). The total scale range is 0-96, and higher scores mean a worse outcome.

  Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.

Secondary Outcomes (2)

• 30-second Chair Stand

  Change from baseline to 9-month follow-up

• 40m Fast-paced Walk

  Change from baseline to 9-month follow-up

Study Arms (2)

STEP-KOA

EXPERIMENTAL

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

Arthritis Education (AE)

ACTIVE COMPARATOR

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

Interventions

Stepped Exercise Program BEHAVIORAL

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

Also known as: STEP-KOA

STEP-KOA

Arthritis Education BEHAVIORAL

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.

Also known as: AE

Arthritis Education (AE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (6)

• Allen KD, Bongiorni D, Caves K, Coffman CJ, Floegel TA, Greysen HM, Hall KS, Heiderscheit B, Hoenig HM, Huffman KM, Morey MC, Ramasunder S, Severson H, Smith B, Van Houtven C, Woolson S. STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2019 May 28;20(1):254. doi: 10.1186/s12891-019-2627-8.

  PMID: 31138256 BACKGROUND

• Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC Health Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7.

  PMID: 33952263 RESULT

• Hughes JM, Bartle JT, Choate AL, Mahanna EP, Meyer CL, Tucker MC, Wang V, Allen KD, Van Houtven CH, Hastings SN. Walking All over COVID-19: The Rapid Development of STRIDE in Your Room, an Innovative Approach to Enhance a Hospital-Based Walking Program during the Pandemic. Geriatrics (Basel). 2021 Nov 10;6(4):109. doi: 10.3390/geriatrics6040109.

  PMID: 34842733 RESULT

• Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, Hales DP, Hu DG, Allen KD. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis. J Clin Rheumatol. 2022 Mar 1;28(2):e415-e421. doi: 10.1097/RHU.0000000000001750.

  PMID: 33902099 RESULT

• Allen KD, Woolson S, Hoenig HM, Bongiorni D, Byrd J, Caves K, Hall KS, Heiderscheit B, Hodges NJ, Huffman KM, Morey MC, Ramasunder S, Severson H, Van Houtven C, Abbate LM, Coffman CJ. Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial. Ann Intern Med. 2021 Mar;174(3):298-307. doi: 10.7326/M20-4447. Epub 2020 Dec 29.

  PMID: 33370174 RESULT

• Kaufman BG, Allen KD, Coffman CJ, Woolson S, Caves K, Hall K, Hoenig HM, Huffman KM, Morey MC, Hodges NJ, Ramasunder S, van Houtven CH. Cost and Quality of Life Outcomes of the STepped Exercise Program for Patients With Knee OsteoArthritis Trial. Value Health. 2022 Apr;25(4):614-621. doi: 10.1016/j.jval.2021.09.018. Epub 2021 Oct 29.

  PMID: 35365305 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Results Point of Contact

• Title: Kelli Allen, Associate Director
• Organization: Center to Accelerate Discovery and Practice Transformation, Durham VA

kelli.allen@va.gov

919-286-0411

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: July 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: July 26, 2019
• Last Updated: February 14, 2024
• Results First Posted: April 7, 2020

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)