The Impact of Chiropractic on Fatigue & the Autonomic Nervous System in Adults With Long COVID-19: a Waitlist-controlled, Single-blind, One-way Crossover, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- FACIT fatigue scale
研究概览
简要总结
The purpose of this waitlist-controlled, single-blind, one-way crossover, pilot trial is to evaluate the potential effects of ~8 weeks of chiropractic care on patient-reported fatigue and the autonomic nervous system in adults with long COVID. This study will allow us to estimate the standard deviation of the primary endpoint in our population with which a formal power calculation for a future randomized, controlled trial can be performed.
详细描述
After providing informed consent, participants will be placed on an 8-week waitlist followed by 8 weeks of chiropractic care. In-person assessments will occur 5 times: Day 1, following 2-3 weeks on waitlist, following 8 weeks on waitlist, following 2-3 weeks of chiropractic care, and following 8 weeks of chiropractic care. Patient-reported outcomes will additionally be sent prior to the first in-person assessment (Day 0).
Assessments will include the following:
- Seated resting recording
- Sit-to-stand test
- Patient-reported outcome surveys
Each assessment will consist of the following recordings:
- Electroencephalography [EEG]
- 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
- 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
- •Participants will be individuals between the age of 18 and 65 who have tested positive for a COVID-19 viral infection, or SARS-CoV-2 antibodies, not less than 120 days prior to their enrollment in the study. Participants may also qualify if they have been medically diagnosed with long-COVID by their medical provider, regardless of a positive test result. They must have a T score greater than or equal to 55 on the FACIT Fatigue survey. They must also present with at least 1 of the following symptoms that cannot be explained by an alternative diagnosis, with symptom onset or exacerbation after contraction of COVID-
- •Body aches/joint pain
- •Shortness of breath or difficulty breathing
- •Persistent chest pain or pressure
- •Recurrent fever, chills or night sweats
- •Headache or dizziness
- •Difficulty concentrating or focusing
- •Memory problems
- •Sleep problems
- •Anxiety or depression
- •Heart palpitations or tachycardia
排除标准
- 未提供
结局指标
主要结局
FACIT fatigue scale
时间窗: Post intervention
Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
次要结局
- ECG mean interbeat interval(Post intervention)
- ECG respiratory sinus arrhythmia (RSA)(Post intervention)
- EEG resting state broadband power(Post intervention)
- EEG resting state functional connectivity(Post intervention)
- Patient-reported outcomes(Post intervention)
- Impedance cardiogram (ICG) pre-ejection period (PEP)(Post intervention)
- Impedance cardiogram (ICG) initial systolic time interval (ISTI)(Post intervention)