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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acceptability of treatment regimen for participants
研究概览
简要总结
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.
详细描述
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:
- Seated resting recording
- Auditory oddball task
- Isometric hand grip
- Postural challenge
- Treadmill walking
- Patient-reported outcome surveys
Each assessment will consist of the following recordings:
- Electroencephalography [EEG]
- Electrodermal activity [EDA]
- Impedance cardiography [ICG]
- Electrocardiogram [ECG]
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Elevated fasting glucose (>100 mg/dL) or drug treatment to reduce blood glucose
排除标准
- •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
- •Individuals with a hearing impairment or hearing aids (due to the auditory stimulus recording being performed)
- •Individuals who are currently pregnant
- •Individuals with current litigation related to a physical, health-related injury
- •Individuals who have been diagnosed with rheumatoid arthritis, osteoporosis or instability of the neck.
- •Individuals with moderate to severe pain on a daily basis
- •Pain on the day of testing rated greater than 3/10 on a visual analog scale (VAS)
结局指标
主要结局
Acceptability of treatment regimen for participants
时间窗: Week 6
9-item acceptability questionnaire
Recruitment rate
时间窗: through study completion, an average of 1 year
Length of time needed to recruit target number of participants
Participant adherence rate
时间窗: through study completion, an average of 1 year
Proportion of participants able to adhere to the testing \& treatment schedule
Participant retention rate
时间窗: through study completion, an average of 1 year
Proportion of enrolled participants who complete the full testing regimen
Participant tolerability rate
时间窗: through study completion, an average of 1 year
Proportion of participants able to perform all aspects of the testing regimen
次要结局
- 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)