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

Oklahoma State University

Status: Completed

Conditions: Life Experiences

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03521401

ED17157

P20GM109097 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. provide written and dated informed consent to participate in the study;
2. be willing and able to comply with the protocol;
3. be between the ages of 18 and 29, inclusive;
4. be free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire;
5. not currently prescribed or taking anti-inflammatory or lipid-lowering medications;
6. have either an ACE score of 0 or 4 or higher;
7. have a BMI between 18.5 and 40.0, inclusive;
8. not enrolled in another clinical trial within thirty days prior to enrollment; and
9. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

ACE - Exercise Group

Experimental group

Description:

Participants with ACE scores of 4 or higher who will undergo exercise training for the duration of the study (experimental).

Treatment:

Behavioral: Exercise

ACE - Non-Exercise Group

No Intervention group

Description:

Participants with ACE scores of 4 or higher who will not undergo exercise training for the duration of the study (+ control).

Non-ACE - Non-Exercise Group

No Intervention group

Description:

Participants with ACE scores of 0 who will not undergo exercise training for the duration of the study (- control).