Clinical trial NCT04325945: Evaluation of Laser Acupuncture on Health Promotion of Sub-health People
Official title: Taipei Veterans General Hospital,Taiwan, R.O.C.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suboptimal Health Status
Keywords: pre-hypertension
insomnia
obesity
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Suboptimal health status (SHS) is a dynamic state wherein people have not been diagnosed with a disease but tend to develop diseases. People with SHS often experience fatigue and other nonspecific symptoms. Early TCM-based interventions in people with SHS can prevent them from developing chronic diseases, thereby reducing the burden on health insurance systems. No study has explored the effects of laser acupuncture (LA) on people with SHS.

Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires, physical status and objective sleep parameters will be assessed in treatment group and control group after the 16th session. In the second year protocol, seventy SHS subjects will be enrolled and same procedure will be performed as the first year protocol.

Detailed description: Background: Suboptimal health status (SHS) is a dynamic state. The term refers to an existing condition of ill health that could lead to a pathological condition but could also be eliminated, enabling the individual in question to return to a state of good health.

Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, TCM intervention will be eliminated SHS becoming to a chronic disease. According to previous studies, people with SHS without sports habits have 8 times risk of developing hypertension. In addition, people with SHS have more rates of sleep disorders, which are associated with obstructive sleep apnea due to decreased oxygen maturation during sleep, than healthy subjects.

A cloud TCM health-care model, which is combined with constitution patterns in TCM and physiological parameters, applied to Taiwanese with SHS. Taiwanese with SHS, no matter yang deficiency, Ying deficiency or Phlegm-stasis patterns, have decreased cardiac parasympathetic activity and high frequency change in pulse power spectrum analysis at right Chi. This phenomenon implied that people with SHS reduced convergence of the ministerial fire in the gate of life and then developed a disharmonic status between "Heart" and "Kidney" in TCM. This theory can explain why SHS has sleep disorders and prehypertension.

Laser acupuncture (LA) has been used in preventive diseases and many effects. Modern researches showed LA improved insomnia, circulation, analgesia and metabolism. However, it is still lacking evidences of objective parameters of sleep and there are no studies about TCM patterns change in SHS by LA.

In this study, the effects of 8 weeks' LA intervention on people with SHS presented with pre-hypertension and/or sleep disorders by a cloud health-care system combined with TCM patterns and physiological parameters will be investigated by 2-years protocols. The result will be helpful to establish the role of LA for preventive medicine in Taiwan.

Hypothesis: Regular LA intervention can improve sleep quality and regulate blood pressure and autonomic nervous function of sub-healthy people. Moreover, combining the cloud-based TCM body constitution and physical healthcare system can help sub-healthy people manage their own health better.

Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and will be assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires will assessed in treatment group and control group before the first session and after the 16th session. In addition, we using mobile cloud-based devices to assess the physical status, such as blood pressure, blood oxygen saturation, physical activity, pulse signal, tongue examination, and autonomic nervous function before and after each sessions. Furthermore, sleep patterns will assessed for at least 2 days.

In the second year protocol, seventy SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled. and assigned into a experiment group and a control group randomly. The evaluation methods are the same as the first year protocol. Besides, we will build up the cloudy system to present body constitution scores and objective parameters. The auto-feedback function will be established in the second year protocol.

Eligibility criteria: Inclusion Criteria:

* Measure blood pressure at rest 120-139 / 80-89 mmHg more than 3 times a week.

PSQI score greater than 5.

Body mass index (BMI) :24\~30 Kg/m2

Exclusion Criteria:

* Patients diagnosed with chronic diseases, such as hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, coronary heart disease and other diseases that fall into the scope of chronic diseases of universal health insurance.

Diagnosis of mental illness.

Cancer patient

Pregnancy

People with significant inflammation at the time of participation.

Primary outcomes:
measure: Blood pressure
timeFrame: Change from Baseline Systolic Blood Pressure at 5 and 8 weeks
measure: Body mass index
timeFrame: Change from Baseline Body Mass Index at 5 and 8 weeks
measure: Sleep quality
timeFrame: Change from Baseline Sleep Quality Index at 5 and 8 weeks
Secondary outcomes:
measure: Brain waves
timeFrame: Change from Baseline Brain Waves at 5 and 8 weeks
measure: Heart rate variability
timeFrame: Change from Baseline Heart Rate Variability at 5 and 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Center for Traditional Medicine, Taipei Veterans General Hospital
Study officials:
affiliation: Center for Traditional Medicine,Taipei Veterans General Hospital
name: Yen-Ying Kung, MD
role: PRINCIPAL_INVESTIGATOR
References: