Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study

Conditions
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Life Experiences

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE - Exercise Group<br>Participants with ACE scores of 4 or higher who will undergo exercise training for the duration of the study (experimental). | Behavioral: Exercise<br>* 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.<br>|
| No Intervention: ACE - Non-Exercise Group<br>Participants with ACE scores of 4 or higher who will not undergo exercise training for the duration of the study (+ control). | |
| No Intervention: Non-ACE - Non-Exercise Group<br>Participants with ACE scores of 0 who will not undergo exercise training for the duration of the study (- control). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | C-reactive protein concentrations (mg/L) will be examined from blood samples taken before- and after- the 8-week training or control period. | 8-weeks | 
| Brain-Derived Neurotrophic Factor | 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 | 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 | Skeletal muscle strength (Newton meters [Nm]) will be determined before- and after- the 8-week training or control period. | 8-weeks | 
| TNF-alpha | 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 | 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 | 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. | 8-weeks | 
| Cortisol | 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. | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | 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 | 
| Anxiety | 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. | 8-weeks | 
| Depression | 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 | Participants' resiliency will be measured using the Connor-Davidson Resilience Scale before- and after- the 8-week training or control period. | 8-weeks | 
| Hope | 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 | 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. | 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resilience, Inflammation, Health, Adverse Childhood Experiences, Exercise Intervention