Psychoneuroimmunology as a Framework for Studying the Effects of Chiropractic Care in a Population With High Central Adiposity: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
Since 1980, the global prevalence of obesity, commonly defined as a body mass index (BMI) of 30 or higher, has doubled. Importantly, high levels of central adiposity (i.e., abdominal fat) is associated with numerous PNI-related sequelae, including increased levels of psychological distress, cognitive deficits, ANS dysfunction, and immune marker abnormalities. To our knowledge, rigorous investigation of chiropractic's impact on psychoneuroimmunological (PNI)-related outcomes in people with high central adiposity is lacking. Based on limited evidence to date, it is plausible that clinically important PNI-related dysfunctions (e.g., heightened stress levels, executive function impairments, dysautonomia, immune dysregulation) common in this population could be ameliorated via chiropractic care.
详细描述
Up to twenty (20) obese individuals (18-65 yrs of age) will be recruited. For our trial, obesity will be indexed as a BMI ≥30 and an elevated waist circumference (i.e., >35 inches for women, >40 inches for men).
Subjects will be asked to do the following…
- Restrict certain behaviors prior to their lab visits which include 1) 3 hours prior abstain from caffeine, brushing your teeth, alcohol-based mouthwash, nicotine, food, & drinking large amounts of liquid very quickly (e.g., chugging a 16 oz bottle of water; sipping water is ok) and 2) 24 hours prior abstain from strenuous exercise, alcohol, & over the counter drugs (e.g., antihistamines, Tylenol, etc.)
- Have their height, weight, and waist circumference measured.
- Drool into a tube for subsequent testing of immune markers (i.e., salivary IgA)
- Have electrodes placed on/around their chest & back to measure respiration, ECG, and impedance cardiography (ICG)
- Perform a postural challenge whereby they lay supine (8 min), stand quickly (3 min), and return quickly to the supine position (3 min).
- Have their cognitive function assessed while walking on a treadmill (dual task).
- Answer questions about their mental, physical, and emotional health.
- Receive 6-weeks of chiropractic adjustments from community-based clinicians.
Assessments will take place at baseline, after 2 weeks of chiropractic, and after 6 weeks of chiropractic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Body mass index (BMI) at least 30
- •Waist circumference at least 35 inches if female or 40 inches if male
排除标准
- •Had chiropractic care within the past 30 days
- •Prescribed short-acting benzodiazepines which include midazolam & triazolam
- •If taking prescription medications, other than short-acting benzodiazepines, not on a stable dose for a minimum of 6 weeks with plans to change medications or doses during the study
- •Not able to walk unassisted on a treadmill
- •Known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
- •Pacemaker or known heart condition that influences the electrical or mechanical function of the heart (e.g., severe heart valve disease)
- •Diagnosed with externalizing (e.g., substance use, antisocial disorder) or thought (e.g., schizophrenia, paranoid personality, bipolar) disorder that is uncontrolled or untreated
- •Diagnosed with rheumatoid arthritis, osteoporosis, or cervical spine instability
- •Hearing impairment (cognitive task uses auditory stimuli)
- •Currently pregnant
- •Current litigation related to a physical, health-related injury
- •Whiplash injury in the past 3 months
- •Oral injury, inflammation, or disease that causes the mouth or gums to bleed easily
研究组 & 干预措施
Chiropractic care
6 weeks of chiropractic care
干预措施: Chiropractic (Procedure)
结局指标
主要结局
Retention
时间窗: 6 weeks
proportion of participants completing the trial
Latency
时间窗: 6 weeks
Average time between first lab assessment \& first chiropractic session
Compliance
时间窗: 6 weeks
proportion of participants complying with pre-assessment lifestyle restrictions
Efficiency
时间窗: 6 weeks
Average battery duration
Tolerability
时间窗: 6 weeks
% of participants able to complete a given assessment
Recruitment
时间窗: up to 6 months
Average number of participants recruited/enrolled per month
Adherence
时间窗: 6 weeks
proportion of participants attending ≥80% of their chiropractic sessions
Acceptability
时间窗: 6 weeks
proportion of participant-rated \& clinician-rated acceptability scores ≥3 in each domain
Data quality
时间窗: 6 weeks
% of acquisitions from a given assessment that are suitable for analysis
次要结局
- Cognitive Flexibility(6 weeks)
- Gait(6 weeks)
- Heart rate variability(6 weeks)
- Pre-ejection period(6 weeks)
- Secretory IgA(6 weeks)
- COMPASS-31(6 weeks)
- PROMIS-29(6 weeks)
- PROMIS-Cog 8(6 weeks)
- Perceived Stress Scale(6 weeks)
研究者
Tyson Perez, DC, PhD
PI
Life University