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Knee OsteoarthritisPhase 2/3NCT05482672

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

A Phase 2/3 study testing Fisetin, GetHealthy-OA mind-body program and Health education booklet in people with Knee Osteoarthritis and Obese, run by Cale Andrew Jacobs, PhD at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Knee Osteoarthritis, Obese, Depression
What is being tested?
Fisetin, GetHealthy-OA mind-body program and Health education booklet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesUnited States
Study dates
Apr 2023to Apr 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild to moderate knee osteoarthritis (Kellgren/Lawrence Grade II or III)
  • Obesity (Body Mass Index > 30 kg/m2)
  • History of concurrent psychotropics for < 2 weeks prior to initiation of treatment or on stable doses for > 6 weeks
  • Access to an internet-enabled computer/smart phone
  • Willingness to comply with the study protocol and assessments
  • Cleared by a medical doctor to participate

Who cannot join

  • Rheumatoid arthritis
  • History of cancer within 5 years of screening; unable to walk/wheelchair-bound
  • Prior surgical fixation of a femur or tibia fracture
  • Taking high doses of opioid pain medication (>50 milligrams of morphine equivalent per day)
  • Diagnosis of a medical illness expected to worsen in the next 6 months (e.g., malignancy)
  • Active suicidal ideation or past-year psychiatric hospitalization; non-English speaking
Show all 30Show fewer
  • Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
  • Current substance abuse or dependence (or a history within the past 6 months)
  • Practice of yoga/meditation, or other mind body techniques once per week > 45 min within the last 3 months
  • Engagement in regular moderate or vigorous physical exercise for >30 min daily
  • Reduced or altered capacity due to administration of any mind-altering substances such as tranquilizers, conscious sedation or anesthesia, or brain injury
  • Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing
  • Females or males who do not wish to abstain from sex or use contraceptive protection during study drug dosing and for 2 weeks after the last dose
  • o Those not willing to use 2 of the following effective forms of contraception: sterilization surgery, intrauterine device (IUD), implantable rod, contraceptive shot/injection, oral contraceptives, patch, vaginal ring, diaphragm with spermicide, sponge with spermicide, cervical cap with spermicide, and/or a male or female condom
  • Subjects who do not have the capacity to consent themselves
  • Subjects who are unable to tolerate oral medication
  • Subjects having previously undergone any of the following treatments in the stated time window.
  • Surgery on the Study Knee in the past 6 months
  • Partial or complete joint replacement in the study knee. Partial or complete joint replacement in the contralateral knee is acceptable as long as the surgery was performed at least 6 months prior to enrollment and the operative knee is asymptomatic
  • Patients who have undergone arthroscopic surgery (including microfracture and meniscectomy) on the Study Knee in the last 2 years prior to the Screening visit or are anticipated to have arthroscopic surgery on either knee at any time during the study period
  • Currently taking Losartan
  • Currently taking Warfarin or related anticoagulants
  • Senolytic agents taken within the past 6 months and are not willing to discontinue these medications through the duration of the study, including: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax
  • Drugs that induce significant cellular stress and are not willing to discontinue these medications through the duration of the study, including alkylating agents, anthracyclines, platins, other chemotherapy drugs
  • Medications that are sensitive substrates or substrates with a narrow therapeutic range for cytochrome P450 family 1 subfamily A member 2 (CYP1A2), cytochrome P450 family 2 subfamily C member 8 (CYP2C8), cytochrome P450 family 2 subfamily C member 9 (CYP2C9), cytochrome P450 family 2 subfamily C member 19 (CYP2C19), cytochrome P450 family 2 subfamily D member 6 (CYP2D6), cytochrome P450 family 3 subfamily A member 4 (CYP3A4), Organic Anion Transporting Polypeptide 1B1 (OATP1B1) or strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4; e.g. cyclosporine, tacrolimus or sirolimus)
  • Subjects taking the following other drugs if they cannot be held (per the Medical Director Austin Stone, MD, PhD) for at least 2 days before and during administration of Fisetin: cyclosporine, tacrolimus, repaglinide, and bosentan
  • Significant liver disease (i.e. greater than or equal to 2x the upper limit of normal bilirubin levels) or as in the opinion of the Medical Director
  • Significant renal disease (estimated glomerular filtration rate (eGFR) of <60 ml/min/1.73m2) or as in the opinion of the Medical Director
  • History of other formally diagnosed joint diseases including osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Cushing's syndrome, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, or neuropathic arthropathy of any cause
  • Patients with type 1 or 2 diabetes (Hemoglobin A1c (HbA1c) > 6.5%) and/or taking medications that affect insulin levels, including: Metformin (within the last week), Glucocorticoids (within the last month), Acarbose (within the last week)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UK Healthcare at Turfland

    Lexington, Kentucky, 40504

  • UK HealthCare Joint Reconstruction and Replacement

    Lexington, Kentucky, 40508

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Fisetin, GetHealthy-OA mind-body program, Placebo oral capsule, Health education booklet
Medical subject headings
Osteoarthritis, Knee, Obesity, Depression

What participants receive

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

  • FisetinDrug

    Also called Novusetin, 7,3',4'-flavon-3-ol, 3,3',4',7-tetrahydroxyflavone

    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.

  • GetHealthy-OA mind-body programBehavioural

    The GetHealthy-OA mind-body program emphasizes increased physical activity, healthy diet and sleep habits to lessen osteoarthritis and depressive symptoms

  • Placebo oral capsuleDrug

    The oral placebo will consist of corn starch and gelatin capsules

  • Health education bookletBehavioural

    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

Study groups in NCT05482672
Study groupRoleWhat they receive
GetHealthy-OAExperimentalThe 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).
Receives: Drug: Fisetin; Behavioral: GetHealthy-OA mind-body program
Minimally Enhanced Usual CarePlacebo comparatorThe 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).
Receives: Drug: Placebo oral capsule; Behavioral: Health education booklet

What is being measured

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

  1. Change in Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)

    The WOMAC is a self-administered questionnaire consisting of 24 items that is widely used in the evaluation of Hip and Knee Osteoarthritis. Scores range from 0 to 96 with lower scores being indicative of less severe osteoarthritis symptoms

    Measured: Change between Baseline and 3 months

  2. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference

    The PROMIS Pain Interference (Short Form 8a v1.0) assesses the consequences of pain on relevant aspects of a person's life including the extent to which pain limits engagement with social, cognitive, emotional, physical, and recreational activities. Scores range from 0 to 100 with greater scores indicative of greater pain interference

    Measured: Change between Baseline and 3 months

  3. Change in Average Daily Step Count

    ActiGraph wGT3X-BTLink accelerometer (ActiGraph, LLC, Fort Walton Beach, FL, USA) will be used to assess average step count over a 7-day period at baseline and the 3 post-intervention time points. This accelerometer is widely used to ecologically assess physical functioning outcomes in chronic pain and older adult trials

    Measured: Change between Baseline and 3 months

Secondary outcomes (11)

  1. Change in serum Interleukin-17 (IL-17)

    IL-17 has been associated with cellular senescence in osteoarthritis, with greater concentrations associated with increased senescent cell activity

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  2. Change in serum IL-4

    IL-4 has been associated with cellular senescence in osteoarthritis, with reduced concentrations associated with increased senescent cell activity

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  3. Change in urinary C-terminal crosslinked telopeptide type II collagen (CTX-II)

    Urinary CTX-II has been identified as a biomarker for the diagnosis, staging, and evaluating the prognosis of hip and knee osteoarthritis

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  4. Change in serum Chondroitin Sulfate epitope 846 (CS846)

    CS846 is a marker of aggrecan synthesis and is elevated in the serum for those with osteoarthritis.

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  5. Change in Pain Numerical Rating Scale

    Consistent with other osteoarthritis trials, patients will be asked to report their average pain over the past 24 hours. Scores range from 0 (no pain) to 10 (extreme pain)

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  6. Change in Walking Speed

    The 40 m walk test will be used to assess walking speed and is recommended by OARSI for the assessment of OA. Increased times are associated with slower walking speed

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  7. Arthritis Self-Efficacy Scale (ASES)

    The ASES assesses arthritis-specific self-efficacy on a 20-item scale. The ASES contains pain (5 items), function (9 items) and other symptoms (6 items) that are scored on a very uncertain (1) to very certain (10) scale. Scores are calculated for 3 subscales (pain, function, other) and range from 1 to 10 and higher average scores indicate greater arthritis-specific self-efficacy

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  8. PROMIS Depression

    The PROMIS Depression (Short Form v1.08b) assesses depressive symptoms. Scores range from 0 to 100 with greater scores indicative of worse depressive symptoms

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  9. PROMIS Anxiety

    The PROMIS Anxiety (Short Form v1.08a) assesses symptoms of anxiety. Scores range from 0 to 100 with greater scores indicative of worse symptoms of anxiety

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  10. Pain Catastrophizing Scale (PCS)

    The PCS assesses hopelessness, helplessness, and negative rumination about pain on a 13-item scale. Higher scores (range = 0 to 52) indicate greater pain catastrophizing

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

  11. RU SATED

    Sleep health is a multidimensional construct, and sleep disturbance is closely tied with knee OA pain and depressive symptoms. We will quantify sleep health using the six-item RU-SATED which is a validated instrument to quantify sleep health, and has been used in populations of older adults. Score range from 0 to 12, with higher scores associated with better sleep health

    Measured: Change between Baseline and 6-weeks, 3-months, and 6-months

Timeline

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

  1. First posted1 Aug 2022
  2. Study startApr 2023 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completionApr 2023 (estimated)

Why it stopped: Lack of funding

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482672
Sponsor's protocol ID
80389
Status last verified
Apr 2023
First submitted
26 Jul 2022
Last updated
1 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fisetin, GetHealthy-OA mind-body program and Health education booklet in people with Knee Osteoarthritis and Obese, run by Cale Andrew Jacobs, PhD at 2 sites 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 6 inclusion and 30 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: withdrawn, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change in Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) (time frame: Change between Baseline and 3 months). The study lists 3 primary outcomes in all. 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 NCT05482672.

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 1 May 2023; AzTrials last refreshed its copy on 5 Nov 2026.

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