Exercise Plus Duloxetine for Knee Osteoarthritis and Depression
|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: NCT04111627|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Depression||Behavioral: Aerobic exercise Drug: Duloxetine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility and Pilot Study of Combined Treatment Protocol Using Aerobic Exercise and Duloxetine in Older Adults With Symptomatic Knee Osteoarthritis and Comorbid Depression|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||November 14, 2023|
|Estimated Study Completion Date :||November 14, 2023|
Experimental: Aerobic exercise plus Duloxetine
Participants will have a starting duloxetine dosage of 30 mg/day and be titrated up to a daily optimal dosage of 60 mg/day as tolerated during the first 12-weeks of the study. Twelve weeks after the receipt of their prescription, participants will be evaluated for the need to increase medication dosage to 90 mg/day. After duloxetine initiation, participants will be provided an exercise prescription that includes a progressive walking program aiming to achieve 50 minutes of moderate-intensity physical activity, three times per week, over 24 weeks.
Behavioral: Aerobic exercise
Participants with symptomatic knee osteoarthritis and depressive symptoms will be enrolled in a progressive walking program designed to reduce pain and disability and improve psychosocial health.
Duloxetine is an FDA-approved selective serotonin and norepinephrine reuptake inhibitor antidepressant approved for the treatment of neuropathic pain in symptomatic knee osteoarthritis as well as depression in adults. Participants with symptomatic knee osteoarthritis and depressive symptoms will receive duloxetine to decrease pain and depression severity to enhance their ability to engage in aerobic exercise.
- Knee Osteoarthritis Outcomes Scale (KOOS) pain subscale [ Time Frame: Change from Baseline Pain Severity at 12 weeks ]The self-reported KOOS pain subscale is sensitive to changes in knee OA symptoms, and consists of nine items scored on a Likert scale (0 [No problems] to 4 [Extreme Problems]) that ranges from 0-36, with higher values indicating greater severity.
- Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Change from Baseline Depression Severity at 12 weeks ]The HAM-D is clinician-administered, 21-item questionnaire, designed to rate the severity of depression in patients. Individual scores are based on the first 17 items, each with a possible score of 0-4 (0=Absent; 4=Extreme Symptoms) or 0-2 (0=Absent; 2=Frequent), yielding an overall range of 0-54. Higher scores indicate greater depression severity.
- Maximal oxygen consumption [ Time Frame: Change from Baseline Peak Maximal Oxygen Consumption at 12 weeks ]Peak maximal oxygen consumption will be assessed while patients are walking on a treadmill, when they are respiring through a non-rebreather mask to collect expired air. Carbon dioxide and oxygen gas concentrations will be measured, and the final 20 seconds of oxygen consumption are averaged to determine peak consumption.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111627
|Contact: Alan M Rathbun, PhD, MPHfirstname.lastname@example.org|