Back to resultsExploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Primary Purpose
Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Health Education
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms
Eligibility Criteria
Inclusion Criteria:
- Experiencing depression symptoms and generally healthy.
Exclusion Criteria:
- Anyone assessed to be unsafe to be enrolled.
Sites / Locations
- Teachers College, Columbia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise
Health Education
Arm Description
This arm will use a resistance exercise curriculum.
This arm will use health education curriculum.
Outcomes
Primary Outcome Measures
Depression symptoms
The Quick Inventory of Depression Symptomatology will be used to assess depression.
Secondary Outcome Measures
Blood lipids
Total cholesterol, HDL, LDL, and triglycerides will be assessed from a blood sample.
Full Information
NCT ID
NCT03107039
First Posted
March 22, 2017
Last Updated
December 22, 2020
Sponsor
Teachers College, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT03107039
Brief Title
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Official Title
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
This arm will use a resistance exercise curriculum.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
This arm will use health education curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
A 12 week resistance exercise curriculum
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
A 12 week health education curriculum
Primary Outcome Measure Information:
Title
Depression symptoms
Description
The Quick Inventory of Depression Symptomatology will be used to assess depression.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blood lipids
Description
Total cholesterol, HDL, LDL, and triglycerides will be assessed from a blood sample.
Time Frame
6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Black or African American
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Experiencing depression symptoms and generally healthy.
Exclusion Criteria:
Anyone assessed to be unsafe to be enrolled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ciccolo, PhD
Organizational Affiliation
Teachers College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35448974
Citation
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.
Results Reference
derived
PubMed Identifier
32863882
Citation
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.
Results Reference
derived
Learn more about this trial
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
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