Suboptimal Health Status Clinical Trial
Official title:
Taipei Veterans General Hospital,Taiwan, R.O.C.
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02103517 -
Fish Oil and Cardiovascular Suboptimal Health
|
Phase 3 | |
| Completed |
NCT02441010 -
Application of Monitoring and Intervention Technologies in Suboptimal Health Status
|
N/A | |
| Recruiting |
NCT05522413 -
Pulse Momentum Research in Pulse Diagnosis
|