Life ExperiencesNCT03521401

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

A study testing Exercise in people with Life Experiences, run by Oklahoma State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for: Life Experiences
What is being tested?: Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 1 May 2018to 10 Nov 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 29 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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;

Show all 9Show fewer

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

192 Colvin Recreation Center
Stillwater, Oklahoma, 74074

Other trials in United States

About this 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.

Conditions: Life Experiences
Being tested: Exercise
Keywords: Adverse Childhood Experiences, Exercise Intervention, Inflammation, Resilience, Health
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExerciseBehavioural
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.

Study groups in NCT03521401
Study group	Role	What they receive
ACE - Exercise Group	Experimental	Participants with ACE scores of 4 or higher who will undergo exercise training for the duration of the study (experimental). Receives: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 8-weeks
Skeletal muscle strength
Skeletal muscle strength (Newton meters [Nm]) will be determined before- and after- the 8-week training or control period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8-weeks

Secondary outcomes (6)

Health-related quality of life
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.
Measured: 8-weeks
Anxiety
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.
Measured: 8-weeks
Depression
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.
Measured: 8-weeks
Resiliency
Participants' resiliency will be measured using the Connor-Davidson Resilience Scale before- and after- the 8-week training or control period.
Measured: 8-weeks
Hope
Participants' levels of hope will be assessed with the 12-item adult hope scale before- and after- the 8-week training or control period.
Measured: 8-weeks
Monocyte Heterogeneity
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.
Measured: 8-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201810 Nov 2019

First posted11 May 2018
Study start1 May 2018
Primary completion10 Nov 2019
Study completion10 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Life ExperiencesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03521401
Sponsor's protocol ID: ED17157
Other IDs: P20GM109097
Status last verified: Mar 2021
First submitted: 29 Mar 2018
Last updated: 3 Mar 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Psoriasis
RecruitingObservational study
PERCE-MUCO: Perceptions and Expectations of People With Cystic Fibrosis Regarding a Change in Treatment
Cystic Fibrosis (CF)
RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
Active, not recruitingObservational study
Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience
Breast Cancer, Quality of Life
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease

All Life Experiences trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study
ClinicalTrials.gov ID: NCT03521401
Acronym / sponsor ID: ED17157
Conditions: Life Experiences
Keywords: Adverse Childhood Experiences, Exercise Intervention, Inflammation, Resilience, Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Oklahoma State UniversityUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 1 May 2018 (actual)
Primary completion: 10 Nov 2019 (actual)
Study completion: 10 Nov 2019 (actual)
First posted: 11 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ACE - Exercise Group	Experimental	Behavioral: ExerciseParticipants with ACE scores of 4 or higher who will undergo exercise training for the duration of the study (experimental).
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).

Who may qualify

Ages: 18 to 29 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExerciseParticipants 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.	Behavioural	ACE - Exercise Group

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.

6 secondary outcomes

Health-related quality of life
Time frame: 8-weeks
Anxiety
Time frame: 8-weeks
Depression
Time frame: 8-weeks
Resiliency
Time frame: 8-weeks
Hope
Time frame: 8-weeks
Monocyte Heterogeneity
Time frame: 8-weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.

Related trials for Life Experiences

Active, not recruitingObservational study
Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Psoriasis
RecruitingObservational study
PERCE-MUCO: Perceptions and Expectations of People With Cystic Fibrosis Regarding a Change in Treatment
Cystic Fibrosis (CF)
RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
Active, not recruitingObservational study
Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience
Breast Cancer, Quality of Life
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Life Experiences, run by Oklahoma State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-reactive protein (time frame: 8-weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521401.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.