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Exercise + Behavioral Health Education for Knee Osteoarthritis (PACIFIC Trial)
N/A
Recruiting
Led By Kushang V Patel, PhD MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Knee pain that occurs almost daily for at least the past 3 months
Physician diagnosis of knee OA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months,10 months
Awards & highlights
PACIFIC Trial Summary
This trial will compare the benefits of adding exercise and behavioral health education to exercise and aging and health education for improving physical activity in adults with painful knee OA.
Who is the study for?
This trial is for community-dwelling adults aged 65 or older with painful knee osteoarthritis, experiencing daily knee pain and difficulty walking or climbing stairs. Participants must not exercise regularly, be able to walk a quarter-mile (cane use okay), and have no major health events like recent heart attacks or strokes.Check my eligibility
What is being tested?
The study tests if combining exercise with behavioral health education improves physical activity more than just exercise with aging and health education in older adults with knee osteoarthritis. It measures the added benefit of this combined approach.See study design
What are the potential side effects?
Since the interventions involve non-pharmaceutical approaches like exercise and educational programs, side effects may include muscle soreness or strain from new physical activities but are generally expected to be minimal.
PACIFIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had knee pain almost every day for the last 3 months.
Select...
My doctor diagnosed me with knee osteoarthritis.
Select...
I experience a crackling sound in my knee.
Select...
I am 65 years old or older.
PACIFIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months,10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months,10 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Number of Steps per day
Secondary outcome measures
6 Minute Walk Test
Fatigue
Knee Pain and Function
+4 morePACIFIC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral HealthExperimental Treatment1 Intervention
Ten behavioral health classes.
Group II: Health EducationActive Control1 Intervention
Ten health education classes covering healthy aging.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,645 Total Patients Enrolled
29 Trials studying Osteoarthritis
9,778 Patients Enrolled for Osteoarthritis
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,486 Total Patients Enrolled
14 Trials studying Osteoarthritis
10,347 Patients Enrolled for Osteoarthritis
Kushang V Patel, PhD MPHPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to have major surgery, like knee or hip replacement, within a year.I have had knee pain almost every day for the last 3 months.You have difficulty with memory or thinking (scoring 3 or less on a cognitive test called Mini-Cog).I do not speak English.I have previously undergone therapy or counseling for pain management.I have major vision or hearing problems that haven't been corrected.You live in your own home or apartment, not in a hospital or nursing home.I have knee pain that makes it hard to walk or climb stairs.My knee is stiff for less than 30 minutes each morning.I am not currently in physical therapy for knee problems or mobility issues.My doctor diagnosed me with knee osteoarthritis.I experience a crackling sound in my knee.I cannot walk a quarter mile by myself but can use a straight cane.In the past 6 months, I haven't had major health issues like heart attack, stroke, or serious surgeries.I cannot or do not want to give consent or be randomly assigned to a study group.You participate in physical activity for at least 20 minutes per week, such as walking, hiking, dancing, strength training, or water exercise.I am 65 years old or older.I am unwilling to wear a thigh-mounted device for a week.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Health
- Group 2: Health Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for people to join this research effort?
"According to clinicaltrials.gov, this research project is actively recruiting participants since its launch date on October 30th 2019 and the most recent update was made January 8 2021."
Answered by AI
How many individuals have been approved for participation in this trial?
"Indeed, the records on clinicaltrials.gov demonstrate that recruitment for this trial is underway. Launched in October of 2019, it was last updated in January 2021 and seeks 280 individuals at 1 centre."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
65+
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
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