Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099394
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kushang Patel, University of Washington

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date October 1, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
Average Number of Steps per day [ Time Frame: 4 months,10 months ]
Participant's average number of steps per day will be measured by a thigh mounted accelerometer (acitvPAL) worn for 1 week.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • Knee Pain and Function [ Time Frame: 4 months, 10 months ]
    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.
  • 6 Minute Walk Test [ Time Frame: 4 months, 10 months ]
    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.
  • Timed Up and Go Test [ Time Frame: 4 months, 10 months ]
    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.
  • Short Physical Performance Battery [ Time Frame: 4 months, 10 months ]
    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.
  • Fatigue [ Time Frame: 4 months, 10 months ]
    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.
  • Study Specific Treatment Satisfaction Questionnaire [ Time Frame: 4 months, 10 months ]
    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.
  • Patient Global Impression of Change [ Time Frame: 4 months, 10 months ]
    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".
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Knee Pain and Function [ Time Frame: 4 months, 10 months ]
    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.
  • 6 Minute Walk Test [ Time Frame: 4 months, 10 months ]
    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.
  • Timed Up and Go Test [ Time Frame: 4 months, 10 months ]
    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.
  • Short Physical Performance Battery [ Time Frame: 4 months, 10 months ]
    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.
  • Fatigue [ Time Frame: 4 months, 10 months ]
    The PROMIS-57 Profile v2.1 will be collected, which includes 8 question items on fatigue.
  • Study Specific Treatment Satisfaction Questionnaire [ Time Frame: 4 months, 10 months ]
    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.
  • Patient Global Impression of Change [ Time Frame: 4 months, 10 months ]
    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".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain & Aging: Combined Interventions for Fitness in the Community Study
Official Title  ICMJE Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults With Painful Knee Osteoarthritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • Behavioral: Behavioral Health
    Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.
  • Behavioral: Health Education
    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 Arms  ICMJE
  • Experimental: Behavioral Health
    Ten behavioral health classes.
    Intervention: Behavioral: Behavioral Health
  • Active Comparator: Health Education
    Ten health education classes covering healthy aging.
    Intervention: Behavioral: Health Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kushang V Patel, PhD, MPH 206-616-8052 kvpatel@uw.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099394
Other Study ID Numbers  ICMJE STUDY00007302
R01AG060992 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kushang Patel, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Kushang V Patel, PhD MPH University of Washington
PRS Account University of Washington
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP