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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03521401
Enrollment
64
Registered
2018-05-11
Start date
2018-05-01
Completion date
2019-11-10
Last updated
2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Life Experiences

Keywords

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

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.

Interventions

BEHAVIORALExercise

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.

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Oklahoma State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Interleukin-1 receptor agonist8-weeksInterleukin-1 receptor agonist concentrations (pg/mL) will be examined from blood samples taken before- and after- the 8-week training or control period.
TNF-alpha8-weeksTNF-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.
Skeletal muscle size8-weeksUltrasound based assessments of skeletal muscle size (cm\^2) will be obtained before- and after- the 8-week training or control period.
Skeletal muscle strength8-weeksSkeletal muscle strength (Newton meters \[Nm\]) will be determined before- and after- the 8-week training or control period.
C-reactive protein8-weeksC-reactive protein concentrations (mg/L) will be examined from blood samples taken before- and after- the 8-week training or control period.
Brain-Derived Neurotrophic Factor8-weeksPlasma 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.
Cortisol8-weeksConcentrations 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.
Skeletal muscle function8-weeksMotor 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.

Secondary

MeasureTime frameDescription
Hope8-weeksParticipants' levels of hope will be assessed with the 12-item adult hope scale before- and after- the 8-week training or control period.
Health-related quality of life8-weeksHealth-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.
Anxiety8-weeksParticipants' levels of anxiety will be assessed using the Zung Self-Rating Anxiety Scale (SAS) before- and after- the 8-week training or control period.
Depression8-weeksParticipants' 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.
Resiliency8-weeksParticipants' resiliency will be measured using the Connor-Davidson Resilience Scale before- and after- the 8-week training or control period.
Monocyte Heterogeneity8-weeksThe 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

MeasureTime frameDescription
Fasting glucose concentrations8-weeksFasting blood glucose concentrations (mg/dL) will be determined for each participant before-, during (week 4), and after- the 8-week training or control period.
Grit8-weeksParticipants' 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.
Self Esteem8-weeksParticipants' levels of self-efficacy will be assessed with the Rosenberg Self-Esteem Scale before- and after- the 8-week training or control period.
Self Efficacy8-weeksParticipants' levels of self-efficacy will be assessed with the General Self-Efficacy Scale before- and after- the 8-week training or control period.
Fasting choleterol concentrations8-weeksFasting blood cholesterol concentrations (mg/dL) will be determined for each participant before-, during (week 4), and after- the 8-week training or control period.
Fasting lipid concentrations8-weeksFasting blood lipid concentrations (mg/dL) will be determined for each participant before-, during (week 4), and after- the 8-week training or control period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026