Clinical trial NCT04099394: Pain & Aging: Combined Interventions for Fitness in the Community Study
Official title: Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults with Painful Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Osteoarthritis
chronic pain
behavioral health
exercise
physical activity
older adults
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-09-23
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* Age 65 years or older
* Community-dwelling
* Physician diagnosis of knee OA
* Knee pain that occurs almost daily for at least the past 3 months
* Knee pain-related difficulty with walking or climbing stairs
* Stiffness in the knee for \<30 min/day in the morning
* Crepitus in the knee

Exclusion criteria:

* Non-English speaking
* Cognitive impairment (Mini-Cog score ≤3)
* Unable or unwilling to give informed consent or accept randomization in either study group
* Unwilling to wear a thigh-mounted accelerometer for 1 week
* Significant, non-corrected visual or hearing impairment
* Plans to move out of the area in the next 12 months
* Plans to have knee, hip, or any other major surgery (including joint replacement) in the next 12 months
* Unable to walk a quarter of a mile independently (use of a straight cane is acceptable)
* Prior participation in cognitive-behavioral therapy or counseling for pain
* Exercises regularly (≥20 minutes/week of walking, hiking, dancing, or strength training, or participate in water exercise)
* Temporary exclusion: Any of the following in the past 6 months: cancer requiring treatment (except for non-melanoma skin cancer), heart attack or failure, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus
* Temporary exclusion: Hospitalization in the past month
* Temporary exclusion: Currently undergoing physical therapy or rehabilitation treatment for knee OA or impairments in mobility function

Primary outcomes:
measure: Average Number of Steps per day
timeFrame: 4 months,10 months
Secondary outcomes:
measure: Knee Pain and Function
timeFrame: 4 months, 10 months
measure: 6 Minute Walk Test
timeFrame: 4 months, 10 months
measure: Timed Up and Go Test
timeFrame: 4 months, 10 months
measure: Short Physical Performance Battery
timeFrame: 4 months, 10 months
measure: Fatigue
timeFrame: 4 months, 10 months
measure: Study Specific Treatment Satisfaction Questionnaire
timeFrame: 4 months, 10 months
measure: Patient Global Impression of Change
timeFrame: 4 months, 10 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kushang V Patel, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.