Evaluation of Laser Acupuncture on Health Promotion of Sub-health People

NCT04325945 | Unknown

• 1 other identifier: 2020-01-026CCF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Suboptimal Health Status

Keywords

pre-hypertension; insomnia; obesity

Outcome Measures

Primary Outcomes (3)

• Blood pressure

  Change from Baseline Systolic Blood Pressure at 5 and 8 weeks

• Body mass index

  Change from Baseline Body Mass Index at 5 and 8 weeks

• Sleep quality

  Pittsburgh sleep quality index

  Change from Baseline Sleep Quality Index at 5 and 8 weeks

Secondary Outcomes (2)

• Brain waves

  Change from Baseline Brain Waves at 5 and 8 weeks

• Heart rate variability

  Change from Baseline Heart Rate Variability at 5 and 8 weeks

Study Arms (2)

Laser acupuncture

EXPERIMENTAL

808nm low level laser therapy

Device: Low level laser therapy

Sham laser acupuncture

SHAM COMPARATOR

no low level laser output but same device

Device: Low level laser therapy

Interventions

Low level laser therapy DEVICE

808nm low level laser therapy on acupuncture points

Laser acupuncture; Sham laser acupuncture

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Center for Traditional Medicine, Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Prehypertension; Sleep Initiation and Maintenance Disorders; Obesity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Yen-Ying Kung, MD

  Center for Traditional Medicine,Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Ying Kung, MD

CONTACT

886-2-28757453; yykung@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Traditional Medicine, Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 30, 2020
• Study Start: April 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

TW (1)