- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107039
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
December 22, 2020 updated by: Teachers College, Columbia University
This study will address a gap in the literature and advance the field of minority men's health.
Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Teachers College, Columbia University
-
-
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.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Experiencing depression symptoms and generally healthy.
Exclusion Criteria:
- Anyone assessed to be unsafe to be enrolled.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
This arm will use a resistance exercise curriculum.
|
A 12 week resistance exercise curriculum
|
|
Active Comparator: Health Education
This arm will use health education curriculum.
|
A 12 week health education curriculum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression symptoms
Time Frame: 6 months
|
The Quick Inventory of Depression Symptomatology will be used to assess depression.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood lipids
Time Frame: 6 months
|
Total cholesterol, HDL, LDL, and triglycerides will be assessed from a blood sample.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joseph Ciccolo, PhD, Teachers College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ciccolo JT, Louie ME, SantaBarbara NJ, Webster CT, Whitworth JW, Nosrat S, Chrastek M, Dunsiger SI, Carey MP, Busch AM. Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy. BMC Psychiatry. 2022 Apr 21;22(1):283. doi: 10.1186/s12888-022-03935-x.
- Busch AM, Louie ME, SantaBarbara NJ, Ajayi AA, Gleason N, Dunsiger SI, Carey MP, Ciccolo JT. Effects of resistance training on depression and cardiovascular disease risk in Black men: Protocol for a randomized controlled trial. Ment Health Phys Act. 2019 Oct;17:100299. doi: 10.1016/j.mhpa.2019.100299. Epub 2019 Sep 12.
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 Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
March 22, 2017
First Submitted That Met QC Criteria
April 4, 2017
First Posted (Actual)
April 11, 2017
Study Record Updates
Last Update Posted (Actual)
December 23, 2020
Last Update Submitted That Met QC Criteria
December 22, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 512156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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