The Effects of Chiropractic Care on the Brain, Autonomic Nervous System, Gait, and Patient Reported Outcomes in Adults With Diagnosed or Suspected Metabolic Syndrome: a Proof-of-concept Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- Life University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Acceptability of treatment regimen for participants
- Status
- Suspended
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome.
Detailed Description
After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 0, Week 2, and Week 6) that each include the following: 1. Seated resting recording 2. Auditory oddball task 3. Isometric hand grip 4. Postural challenge 5. Treadmill walking 6. Patient-reported outcome surveys Each assessment will consist of the following recordings: 1. Electroencephalography \[EEG\] 2. Electrodermal activity \[EDA\] 3. Impedance cardiography \[ICG\] 4. Electrocardiogram \[ECG\]
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals over the age of 18
- •Individuals who can wear an EEG net for 30 minutes
- •Individuals who can sit quietly for at least 15 minutes
- •Individuals who can walk unassisted for up to 10 minutes
- •Individuals who can provide informed consent
- •Individuals who meet 3 of the 5 following criteria:
- •Elevated waist circumference (\>40 in/102 cm if male and \>35 in/88cm if female)
- •Elevated triglycerides (\>150 mg/dL) or drug treatment for elevated triglycerides
- •Reduced HDL-cholesterol (\<40mg/dL if male and \<50 mg/dL if female) or drug treatment to increase HDL-C
- •Elevated blood pressure (\>130 mm Hg systolic BP or \>85 mm Hg diastolic BP) or drug treatment to reduce blood pressure
Exclusion Criteria
- •Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
- •Individuals with impaired function of the dominant hand
- •Individuals with malignant hypertension
- •Individuals with a known heart condition such as arrhythmia that results in an aberrant ECG recording
- •Individuals with any implanted devices (i.e., pacemakers)
- •Individuals with brain aneurysms
- •Individuals with a history of epilepsy or stroke that would influence EEG readings
- •Individuals with a diagnosed externalizing or thought disorder (i.e., anti-social disorder, any major personality disorder such as borderline personality disorder, or schizophrenia)
- •Individuals who are on short-acting benzodiazepines which include midazolam \& triazolam
- •Individuals with any serious injury or surgery to the head or torso, or lower body in the last 6 months
Outcomes
Primary Outcomes
Acceptability of treatment regimen for participants
Time Frame: Week 6
9-item acceptability questionnaire
Recruitment rate
Time Frame: through study completion, an average of 1 year
Length of time needed to recruit target number of participants
Participant adherence rate
Time Frame: through study completion, an average of 1 year
Proportion of participants able to adhere to the testing \& treatment schedule
Participant retention rate
Time Frame: through study completion, an average of 1 year
Proportion of enrolled participants who complete the full testing regimen
Participant tolerability rate
Time Frame: through study completion, an average of 1 year
Proportion of participants able to perform all aspects of the testing regimen
Secondary Outcomes
- EEG resting state functional connectivity(Week 6)
- EEG evoked latency(Week 6)
- ECG respiratory sinus arrhythmia (RSA)(Week 6)
- Electrodermal activity (EDA) power spectral density (PSD)(Week 6)
- Composite Autonomic Symptom Score COMPASS-31)(Day 1)
- EEG evoked amplitude(Week 6)
- skin conductance level (SCL)(Week 6)
- ECG mean interbeat interval(Week 6)
- EEG resting state broadband power(Week 6)
- Composite Autonomic Symptom Score (COMPASS-31)(Week 6)
- Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)(Week 6)
- Perceived Stress Scale (PSS)(Week 6)
- Impedance cardiogram (ICG) pre-ejection period (PEP)(Week 6)
- ECG de-trended fluctuation analysis(Week 6)
- Impedance cardiogram (ICG) initial systolic time interval (ISTI)(Week 6)
- Electrodermal activity (EDA) non-specific skin conductance responses (SCR)(Week 6)