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Flavonoid

GetHealthy-OA mind-body program for Osteoarthritis

Phase 2 & 3
Waitlist Available
Research Sponsored by Cale Andrew Jacobs, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and 6-weeks, 3-months, and 6-months
Awards & highlights

Study Summary

This trial will compare the GetHealthy-OA program, which combines a mind-body program with the oral supplement fisetin, to minimally-enhanced usual care plus an oral placebo, to see if it can reduce the risk of joint degeneration and worsening pain for people with knee osteoarthritis who are also depressed and overweight.

Eligible Conditions
  • Osteoarthritis of the Knee
  • Obesity
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and 6-weeks, 3-months, and 6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and 6-weeks, 3-months, and 6-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Average Daily Step Count
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Change in Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
Secondary outcome measures
Arthritis Self-Efficacy Scale (ASES)
Change in Pain Numerical Rating Scale
Change in Walking Speed
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GetHealthy-OAExperimental Treatment2 Interventions
The GetHealthy-OA program combines a 6-week mind-body program delivered via live video with the oral supplement fisetin. Oral fisetin will be taken for 2 consecutive days (day 1 and 2), a 28-day wash-out period, and then another 2-day course (days 31 and 32).
Group II: Minimally Enhanced Usual CarePlacebo Group2 Interventions
The minimally enhanced usual care group will be given a health education booklet at the date of baseline testing and will take an oral placebo for 2 consecutive days (day 1 and 2) and then again 28 days later (days 29 and 30).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Cale Andrew Jacobs, PhDLead Sponsor
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,355 Total Patients Enrolled
20 Trials studying Osteoarthritis
4,630 Patients Enrolled for Osteoarthritis
Cale Jacobs, PhDLead Sponsor
4 Previous Clinical Trials
138 Total Patients Enrolled
1 Trials studying Osteoarthritis
30 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are researchers expecting to learn from this clinical trial?

"The primary outcome variable of this study, which will be assessed over a three-month period, is the change in average daily step count. Additionally, research participants' serum levels of interleukin-17 (IL-17) will be monitored as a secondary outcome; increased IL-17 activity has been linked to cellular senescence in osteoarthritis patients. Finally, self-reported pain scores and arthritis self-efficacy will also be collected as measures ofsecondary outcomes."

Answered by AI

Are there any subjects needed for this research project?

"Unfortunately, this particular trial is no longer recruiting patients. The clinicaltrials.gov website indicates that the last update to this posting was on July 28th, 2022. There are, however, 2090 other trials which are still searching for participants."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
UK HealthCare Joint Reconstruction and Replacement
Recent research and studies
clinicaltrials.govStudy
GetHealthy-OA: A Program to Improve Pain and Function for Patients With Knee Osteoarthritis, Obesity, and Depression
Cale Andrew Jacobs, PhD 2023. "GetHealthy-OA: A Program to Improve Pain and Function for Patients With Knee Osteoarthritis, Obesity, and Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05482672.
~0 spots leftby Apr 2025
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