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

NCT03521401 | Completed

• 2 other identifiers: ED17157P20GM109097
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Life Experiences

Keywords

Adverse Childhood Experiences; Exercise Intervention; Inflammation; Resilience; Health

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Health-related quality of life

  8-weeks

• Anxiety

  8-weeks

• Depression

  8-weeks

• Resiliency

  8-weeks

• Hope

  8-weeks

Other Outcomes (6)

• Fasting glucose concentrations

  8-weeks

• Fasting lipid concentrations

  8-weeks

• Fasting choleterol concentrations

  8-weeks

Study Arms (3)

ACE - Exercise Group

EXPERIMENTAL

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

Behavioral: Exercise

ACE - Non-Exercise Group

NO INTERVENTION

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

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

Interventions

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.

ACE - Exercise Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Oklahoma State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

192 Colvin Recreation Center

Stillwater, Oklahoma, 74074, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: May 11, 2018
• Study Start: May 1, 2018
• Primary Completion: November 10, 2019
• Study Completion: November 10, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)