- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03521401
Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study
March 1, 2021 updated by: Oklahoma State University
The process by which the body responds to stressors to maintain homeostasis is called allostasis and is dependent on the integrated function of the nervous, endocrine, and immune systems.
ACEs adversely affect these system, cause allostatic load, and can modify development of allostatic systems.
However, the central hypothesis is that exercise can reduce allostatic load by positively augmenting function of each of these three systems.
No previous studies have examined the effects of structured exercise interventions in individuals with ACEs.
The investigators are studying the effects of 8-weeks of structured resistance and aerobic exercise on biomarkers related to nervous, endocrine, immune, and metabolic function and several clinical outcomes in young adult women with ACEs.
The specific aims will test several hypotheses, and are as follows: SPECIFIC AIM 1: Conduct a feasibility study to explore whether progressive, structured exercise can help mitigate the adverse physiological effects of stress and trauma early in life.
SPECIFIC AIM 2: Determine whether progressive, structured exercise can help improve health-related quality of life, anxiety, and traits like hope, self-efficacy, or self-control, resilience.
SPECIFIC AIM 3: Determine whether the type and timing of exposure to ACEs has a significant influence on the severity of psychopathology and long-term physiological response to ACEs.
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
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
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Oklahoma
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Stillwater, Oklahoma, United States, 74074
- 192 Colvin Recreation Center
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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
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- provide written and dated informed consent to participate in the study;
- be willing and able to comply with the protocol;
- be between the ages of 18 and 29, inclusive;
- be free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire;
- not currently prescribed or taking anti-inflammatory or lipid-lowering medications;
- have either an ACE score of 0 or 4 or higher;
- have a BMI between 18.5 and 40.0, inclusive;
- not enrolled in another clinical trial within thirty days prior to enrollment; and
- answer no to all questions on the PAR-Q for people aged 15 to 69, which assesses a person's eligibility to engage in exercise without contraindications.
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACE - Exercise Group
Participants with ACE scores of 4 or higher who will undergo exercise training for the duration of the study (experimental).
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Participants assigned to the exercise group will undergo structured, progressive resistance and aerobic exercise for 8 weeks.
Resistance training and aerobic training will each be completed twice weekly for a total of 16 resistance and 16 aerobic exercise training sessions.
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No Intervention: ACE - Non-Exercise Group
Participants with ACE scores of 4 or higher who will not undergo exercise training for the duration of the study (+ control).
|
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No Intervention: Non-ACE - Non-Exercise Group
Participants with ACE scores of 0 who will not undergo exercise training for the duration of the study (- control).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive protein
Time Frame: 8-weeks
|
C-reactive protein concentrations (mg/L) will be examined from blood samples taken before- and after- the 8-week training or control period.
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8-weeks
|
Brain-Derived Neurotrophic Factor
Time Frame: 8-weeks
|
Plasma concentrations of brain-derived neurotrophic factor (BDNF; pg/mL), a biomarker of neurogenesis, will be examined from blood samples taken before- and after- the 8-week training or control period.
|
8-weeks
|
Skeletal muscle size
Time Frame: 8-weeks
|
Ultrasound based assessments of skeletal muscle size (cm^2) will be obtained before- and after- the 8-week training or control period.
|
8-weeks
|
Skeletal muscle strength
Time Frame: 8-weeks
|
Skeletal muscle strength (Newton meters [Nm]) will be determined before- and after- the 8-week training or control period.
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8-weeks
|
TNF-alpha
Time Frame: 8-weeks
|
TNF-alpha concentrations (pg/mL) will be examined from blood samples taken before- and after- the 8-week training or control period.
TNF-alpha is a cytokine involved in systemic inflammation.
|
8-weeks
|
Interleukin-1 receptor agonist
Time Frame: 8-weeks
|
Interleukin-1 receptor agonist concentrations (pg/mL) will be examined from blood samples taken before- and after- the 8-week training or control period.
|
8-weeks
|
Skeletal muscle function
Time Frame: 8-weeks
|
Motor unit behavior will be assessed utilizing surface electromyographic signal decomposition, which will be collected while participants perform submaximal isometric (i.e., static) muscle actions.
These signals will be collected before- and after- the 8-week training or control period.
To examine motor unit behavior, the relationship between motor unit recruitment threshold versus firing rate will be determined for all detected motor units for an individual subject.
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8-weeks
|
Cortisol
Time Frame: 8-weeks
|
Concentrations of salivary cortisol (µg/dL), a stress hormone, will be obtained twice in one day (8 h between samples) before- and after- the 8-week training or control period.
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8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life
Time Frame: 8-weeks
|
Health-Related Quality of Life: The RAND 36-item short form survey instrument (SF-36) will be used to assess health-related quality of life (HQROL) before- and after- the 8-week training or control period.
This will serve as an overall assessment of each individuals' perception of their health.
|
8-weeks
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Anxiety
Time Frame: 8-weeks
|
Participants' levels of anxiety will be assessed using the Zung Self-Rating Anxiety Scale (SAS) before- and after- the 8-week training or control period.
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8-weeks
|
Depression
Time Frame: 8-weeks
|
Participants' levels of depression will be measured utilizing the Center for Epidemiologic Studies Depression Scale Revised (CESD-R) before- and after- the 8-week training or control period.
|
8-weeks
|
Resiliency
Time Frame: 8-weeks
|
Participants' resiliency will be measured using the Connor-Davidson Resilience Scale before- and after- the 8-week training or control period.
|
8-weeks
|
Hope
Time Frame: 8-weeks
|
Participants' levels of hope will be assessed with the 12-item adult hope scale before- and after- the 8-week training or control period.
|
8-weeks
|
Monocyte Heterogeneity
Time Frame: 8-weeks
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The heterogeneity of monocyte populations will be determined from the white blood cells in blood plasma using flow cytometry.
The relative number (%) of CD14++CD16- vs. CD14+CD16++ vs. CD14++CD16+ monocytes will be determined for each participant before- and after- the 8-week training or control period.
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8-weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting glucose concentrations
Time Frame: 8-weeks
|
Fasting blood glucose concentrations (mg/dL) will be determined for each participant before-, during (week 4), and after- the 8-week training or control period.
|
8-weeks
|
Fasting lipid concentrations
Time Frame: 8-weeks
|
Fasting blood lipid concentrations (mg/dL) will be determined for each participant before-, during (week 4), and after- the 8-week training or control period.
|
8-weeks
|
Fasting choleterol concentrations
Time Frame: 8-weeks
|
Fasting blood cholesterol concentrations (mg/dL) will be determined for each participant before-, during (week 4), and after- the 8-week training or control period.
|
8-weeks
|
Self Efficacy
Time Frame: 8-weeks
|
Participants' levels of self-efficacy will be assessed with the General Self-Efficacy Scale before- and after- the 8-week training or control period.
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8-weeks
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Self Esteem
Time Frame: 8-weeks
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Participants' levels of self-efficacy will be assessed with the Rosenberg Self-Esteem Scale before- and after- the 8-week training or control period.
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8-weeks
|
Grit
Time Frame: 8-weeks
|
Participants' levels of Grit will be measured using the 12-item Grit scale, which assesses passion and perseverance for achieving long-term goals, before- and after- the 8-week training or control period.
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8-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
May 1, 2018
Primary Completion (Actual)
November 10, 2019
Study Completion (Actual)
November 10, 2019
Study Registration Dates
First Submitted
March 29, 2018
First Submitted That Met QC Criteria
May 9, 2018
First Posted (Actual)
May 11, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ED17157
- P20GM109097 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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