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

NCT ID: NCT03521401

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-11-10

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.

Detailed Description

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Conditions

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Life Experiences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACE - Exercise Group

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-ACE - Non-Exercise Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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192 Colvin Recreation Center

Stillwater, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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P20GM109097

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ED17157

Identifier Type: -

Identifier Source: org_study_id

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