NCT05482672

GetHealthy-OA: A Program to Improve Pain and Function for Patients With Knee Osteoarthritis, Obesity, and Depression

GetHealthy-OA: A Biopsychosocial Treatment Approach to Improve Pain and Function for Patients With Comorbid Knee Osteoarthritis, Obesity, and Depression

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cale Andrew Jacobs, PhD · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The investigators have previously identified knee osteoarthritis patients with the combination of depression and an unhealthy weight may be an increased risk of more rapid joint degeneration and worsening pain. The GetHealthy-OA program combines a mind-body program with the oral supplement fisetin to potentially reduce the risk for this population by treating psychosocial, mechanical, and inflammatory mechanisms of knee osteoarthritis. This randomized clinical trial will compare the GetHealthy-OA program to minimally-enhanced usual care plus an oral placebo.

Detailed description

The study will employ a double-blind, randomized, placebo-controlled clinical trial to compare the the multimodal GetHealthy-OA program versus placebo. As part of this clinical trial, 120 patients will be randomized to 1 of 2 groups: The GetHealthy-OA program that combines a mind-body program with oral fisetin versus a control group treated with an oral placebo and minimally-enhanced usual care (MEUC). The GetHealthy-OA group will participate in the 6-week the mind-body program and will take oral fisetin for 2 consecutive days (day 1 and 2), a 28-day wash-out period, and then another 2-day course (days 31 and 32). The MEUC group will be given a health education handout 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). To determine if immediate improvements are realized and whether gains are sustained after the completing the program, participants will be assessed at baseline, 6 weeks, 3 months, and 6 months. The GetHealthy-OA mind-body program is a live-video, group program delivered via secure telehealth with mind-body skills to reduce pain and increase physical activity to promote optimal joint loading. The on-line program will be delivered remotely by a psychologist based at Massachusetts General Hospital via Zoom and we will assess symptoms and monitor any technical difficulties. The program consist of 6 sessions that will last about 45 minutes. The sessions are done on your smartphone or computer, and will include a group of 4 to 5 other people with knee arthritis who are also taking part in the study with you at the same time. The GetHealthy-OA group will participate in the 6-week the mind-body program and will take oral fisetin for 2 consecutive days (day 1 and 2), a 28-day wash-out period, and then another 2-day course (days 31 and 32). The MEUC group will be given a health education booklet at the date of baseline testing and will take an oral placebo (corn starch) for 2 consecutive days (day 1 and 2) and then again 28 days later (days 29 and 30). The booklet will contain brief summarized information that reflects the active intervention topics including the trajectory of pain and recovery for those with knee osteoarthritis, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living. The MEUC will be given an oral placebo (corn starch) that is identical to the fisetin capsules with the same dosing regimen as the GetHealthy-OA group. Similar to participants in GetHealthy-OA group, participants in this group will receive usual medical care as determined by the medical team. Usual care involves meetings with physicians, medical staff, and physical therapy. Usual care is identical in intervention and control groups.

Conditions

• Knee Osteoarthritis
• Obese
• Depression

Interventions

Type	Name	Description
DRUG	Fisetin	Fisetin is a plant flavanol senolytic found in strawberries, persimmons, and cucumbers. This naturally derived senolytic has few side effects and previous animal models of both osteoarthritis and rheumatoid arthritis have demonstrated that the senolytic supplement fisetin reduces inflammation and slows cartilage breakdown.
BEHAVIORAL	GetHealthy-OA mind-body program	The GetHealthy-OA mind-body program emphasizes increased physical activity, healthy diet and sleep habits to lessen osteoarthritis and depressive symptoms
DRUG	Placebo oral capsule	The oral placebo will consist of corn starch and gelatin capsules
BEHAVIORAL	Health education booklet	The booklet will containing brief summarized information that reflects the active intervention topics including the trajectory of pain and recovery for those with knee osteoarthritis, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2022-08-01
• Last updated: 2023-05-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study