Clinical trial NCT03521401: Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study
Official title: Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Experiences
Keywords: Adverse Childhood Experiences
Exercise Intervention
Inflammation
Resilience
Health
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-05-11
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: C-reactive protein
timeFrame: 8-weeks
measure: Brain-Derived Neurotrophic Factor
timeFrame: 8-weeks
measure: Skeletal muscle size
timeFrame: 8-weeks
measure: Skeletal muscle strength
timeFrame: 8-weeks
measure: TNF-alpha
timeFrame: 8-weeks
measure: Interleukin-1 receptor agonist
timeFrame: 8-weeks
measure: Skeletal muscle function
timeFrame: 8-weeks
measure: Cortisol
timeFrame: 8-weeks
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 8-weeks
measure: Anxiety
timeFrame: 8-weeks
measure: Depression
timeFrame: 8-weeks
measure: Resiliency
timeFrame: 8-weeks
measure: Hope
timeFrame: 8-weeks
measure: Monocyte Heterogeneity
timeFrame: 8-weeks
Other outcomes:
measure: Fasting glucose concentrations
timeFrame: 8-weeks
measure: Fasting lipid concentrations
timeFrame: 8-weeks
measure: Fasting choleterol concentrations
timeFrame: 8-weeks
measure: Self Efficacy
timeFrame: 8-weeks
measure: Self Esteem
timeFrame: 8-weeks
measure: Grit
timeFrame: 8-weeks
Locations:
city: Stillwater
country: United States
facility: 192 Colvin Recreation Center
state: Oklahoma
Study officials:
References: