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Completed

NCT Number: NCT03521401

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

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.

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Key information

Conditions

Life Experiences Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

192 Colvin Recreation Center

Stillwater, Oklahoma, 74074, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Monocyte Heterogeneity

    Time frame: 8-weeks

    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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Self Esteem

    Time frame: 8-weeks

    Participants' levels of self-efficacy will be assessed with the Rosenberg Self-Esteem Scale before- and after- the 8-week training or control period.

  6. 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.

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 11, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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