COMPLETED

Exercise Plus Duloxetine for Knee Osteoarthritis

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested.

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

Quick Facts

Study Start:2021-10-07

Study Completion:2025-08-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04111627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. English speaking 2. 40 years or older 3. Symptomatic knee osteoarthritis fulfilling 1986 American College of Rheumatology criteria 4. No plan for surgical knee osteoarthritis intervention within six months of enrollment 5. Major depressive disorder satisfying diagnostic criteria according to the DSM-V 6. Ability to participate in a supervised aerobic exercise program	1. Already performing aerobic or resistive exercise 2x/week or more 2. Taking duloxetine, antipsychotics, benzodiazepines, or opioid analgesics 3. Other medications deemed by study team to endanger the health of the participant or unduly confound the results 4. Cognitive impairment (Mini-Mental State Examination score \< 20) 5. Past or current bipolar disorder or psychotic symptoms according to the DSM-V 6. Substance abuse disorder or suicidal ideation within the previous year 7. Not able to participate in a supervised exercise program based on the presence of unstable angina, recent MI (within last 3 months), hemiparetic gait, inability to walk at least 1mph on treadmill safely, poorly controlled hypertension (resting blood pressure \> 190/110), peripheral arterial disease with current foot or leg ulcers, or cardiac or pulmonary disease with exercise tolerance NYHA class 3 or higher. 8. Active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy) 9. Pregnant or lactating women 10. Other conditions deemed by study team to endanger the health of the participant or unduly confound the results

Inclusion Criteria

Exclusion Criteria

1. English speaking
2. 40 years or older
3. Symptomatic knee osteoarthritis fulfilling 1986 American College of Rheumatology criteria
4. No plan for surgical knee osteoarthritis intervention within six months of enrollment
5. Major depressive disorder satisfying diagnostic criteria according to the DSM-V
6. Ability to participate in a supervised aerobic exercise program

1. Already performing aerobic or resistive exercise 2x/week or more
2. Taking duloxetine, antipsychotics, benzodiazepines, or opioid analgesics
3. Other medications deemed by study team to endanger the health of the participant or unduly confound the results
4. Cognitive impairment (Mini-Mental State Examination score \< 20)
5. Past or current bipolar disorder or psychotic symptoms according to the DSM-V
6. Substance abuse disorder or suicidal ideation within the previous year
7. Not able to participate in a supervised exercise program based on the presence of unstable angina, recent MI (within last 3 months), hemiparetic gait, inability to walk at least 1mph on treadmill safely, poorly controlled hypertension (resting blood pressure \> 190/110), peripheral arterial disease with current foot or leg ulcers, or cardiac or pulmonary disease with exercise tolerance NYHA class 3 or higher.
8. Active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy)
9. Pregnant or lactating women
10. Other conditions deemed by study team to endanger the health of the participant or unduly confound the results

Contacts and Locations

Study Locations (Sites)

University of Maryland School of Medicine

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-07

Study Completion Date2025-08-11

Study Record Updates

Study Start Date2021-10-07

Study Completion Date2025-08-11

Terms related to this study

Additional Relevant MeSH Terms

Knee Osteoarthritis
Depression