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Osteo Arthritis KneePACIFICNCT04099394

Pain & Aging: Combined Interventions for Fitness in the Community Study

A study testing Behavioral Health and Health Education in people with Osteo Arthritis Knee, run by University of Washington at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Behavioral Health and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
30 Oct 2019to 31 Jan 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195-6540

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults with Painful Knee Osteoarthritis

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).

Read the 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.

Being tested
Behavioral Health, Health Education
Keywords
Osteoarthritis, chronic pain, behavioral health, exercise, physical activity, older adults
Medical subject headings
Osteoarthritis, Chronic Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral HealthBehavioural

    Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.

  • Health EducationBehavioural

    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).

Study groups in NCT04099394
Study groupRoleWhat they receive
Behavioral HealthExperimentalTen behavioral health classes.
Receives: Behavioral: Behavioral Health
Health EducationActive comparatorTen health education classes covering healthy aging.
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months,10 months

Secondary outcomes (7)

  1. 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.

    Measured: 4 months, 10 months

  2. 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.

    Measured: 4 months, 10 months

  3. 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.

    Measured: 4 months, 10 months

  4. 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.

    Measured: 4 months, 10 months

  5. 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.

    Measured: 4 months, 10 months

  6. 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.

    Measured: 4 months, 10 months

  7. 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".

    Measured: 4 months, 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start30 Oct 2019
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099394
Sponsor's protocol ID
STUDY00007302
Other IDs
R01AG060992
Acronym
PACIFIC
Status last verified
Jan 2025
First submitted
18 Sep 2019
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27014966

  • 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.

    PubMed 14718492

  • 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.

    PubMed 24387819

  • 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.

    PubMed 25569281

  • 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/

    PubMed 28825779

  • 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.

    PubMed 19462551

  • 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.

    PubMed 20495156

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Health and Health Education in people with Osteo Arthritis Knee, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Number of Steps per day (time frame: 4 months,10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04099394, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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