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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG060992 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This clinical trial will determine the added benefit of combining exercise and behavioral health education (versus exercise and aging and health education) to improve physical activity in community-dwelling older adults who have painful knee osteoarthritis (OA).
Knee osteoarthritis (OA) is a highly prevalent, leading cause of pain that limits physical functioning in older adults. Although clinical practice guidelines recommend physical exercise for managing symptoms of knee OA, several systematic reviews indicate that exercise intervention studies provide only short-term benefits (lasting 6 months) for knee OA. Many older adults with painful knee OA return to sedentary lifestyles when structured exercise programs end6. Efforts to increase and sustain physical activity in this population will require promoting self-regulatory skills to develop confidence to maintain an active lifestyle and manage symptoms that often limit activity. Therefore, we developed a group-based behavioral health (BH) program for older adults with painful knee OA that complements Enhance Fitness (EF) - a multicomponent, community-based exercise program for older adults, involving balance, strength, and endurance training. The Behavioral Health (BH) program will have 10, 1-hour weekly classes spread over 4 months, while the Health Education (HE) program will be equally matched for attention with classes on aging and health. In parallel with BH/HE programs, all study subjects will participate in Enhance Fitness (EF) exercise classes that will be held for 1-hour, 3 times a week for 4 months. EF+BH intervention (versus EF+HE) improves physical activity, pain, physical function, and other outcomes in older adults with knee OA. Due to the COVID-19 pandemic, all interventions transitioned to remote delivery in 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Health | Experimental | Ten behavioral health classes. |
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| Health Education | Active Comparator | Ten health education classes covering healthy aging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Health | Behavioral | Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Steps per day | Participant's average number of steps per day will be measured by a thigh mounted accelerometer (acitvPAL) worn for 1 week. | 4 months,10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Pain and Function | The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used. This is a reliable, validated, and widely used patient-reported outcome measure for assessing knee pain and knee pain-related functional limitations in clinical trials of exercise in adults with knee OA. The knee pain and knee pain-related functional limitation subscales range 0-100 with higher scores indicating better outcome. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kushang V Patel, PhD MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195-6540 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27014966 | Background | Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3. | |
| 14718492 | Background | Leveille SG, Fried LP, McMullen W, Guralnik JM. Advancing the taxonomy of disability in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jan;59(1):86-93. doi: 10.1093/gerona/59.1.m86. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001524 | Behavioral Medicine |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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| Health Education | Behavioral | Ten, group-based classes lasting one hour each that teaches topics related to aging and health (e.g., blood pressure control, maintaining healthy bones, cancer screening, immunizations). |
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| 4 months, 10 months |
| 6 Minute Walk Test | Mobility will be measured by the 6-Minute Walk Test. This is a recommended performance-based measures to assess interventions in adults with knee OA and in older adults in general, facilitating comparisons with previous exercise trials. | 4 months, 10 months |
| Timed Up and Go Test | Mobility will be measured by the Timed up Go. This is a recommended performance-based measures to assess interventions in adults with knee OA and in older adults in general, facilitating comparisons with previous exercise trials. | 4 months, 10 months |
| Short Physical Performance Battery | Mobility will be measured by the Short Physical Performance Battery. This is a recommended performance-based measures to assess interventions in adults with knee OA and in older adults in general, facilitating comparisons with previous exercise trials. | 4 months, 10 months |
| Fatigue | The PROMIS-57 Profile v2.1 will be collected, which includes 8 question items on fatigue. The PROMIS fatigue score ranges 0-100 with higher scores indicating worse outcome. | 4 months, 10 months |
| Study Specific Treatment Satisfaction Questionnaire | This multi-item measure assesses overall participant satisfaction with the study as well as individual treatment components. These questions were developed specifically for the PACIFIC Study. Overall and treatment-specific satisfaction scores range 20-100 with higher scores indicating better outcome. | 4 months, 10 months |
| Patient Global Impression of Change | This is a widely used single item assessment of overall change in health status following treatment on a 7-point scale. Participants are asked, "Since the start of the study my overall status is: (1) Very much improved; (2) Much improved; (3) Minimally improved; (4) No change; (5) Minimally worse; (6) Much worse; and (7) Very much worse". | 4 months, 10 months |
| 24387819 | Background | Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4. |
| 25569281 | Background | Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD004376. doi: 10.1002/14651858.CD004376.pub3. |
| 28825779 | Background | Newberry SJ, FitzGerald J, SooHoo NF, Booth M, Marks J, Motala A, Apaydin E, Chen C, Raaen L, Shanman R, Shekelle PG. Treatment of Osteoarthritis of the Knee: An Update Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 May. Report No.: 17-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK447543/ |
| 19462551 | Background | Focht BC. Effectiveness of exercise interventions in reducing pain symptoms among older adults with knee osteoarthritis: a review. J Aging Phys Act. 2006 Apr;14(2):212-35. doi: 10.1123/japa.14.2.212. |
| 20495156 | Background | Newman AB, Bayles CM, Milas CN, McTigue K, Williams K, Robare JF, Taylor CA, Albert SM, Kuller LH. The 10 keys to healthy aging: findings from an innovative prevention program in the community. J Aging Health. 2010 Aug;22(5):547-66. doi: 10.1177/0898264310363772. Epub 2010 May 21. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |