- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04202900
Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions
Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions and Its Translation Application
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
From literature review of LED phototherapy can effectively improve symptoms in the elderly, such as hair loss, dermatitis, rotator tendonitis, epicondylitis of the tibia, wound healing, back pain, patellofemoral pain, spinal neuropathy, chronic pain relief, insomnia and depression.
Comprehensive Phototherapy and Traditional Chinese medicine(TCM) perspective, LED phototherapy is the use of physical light energy stimulation and temperature to improve the body's microcirculation and meridian dredge, Enhance the body's energy of the health and sub-health elderly, increasing physical activity perform daily functions.
Taiwanese Elderly to take self-care by the dilemmas of the many aspects. There are 21.52% physical health problems, affecting work or daily activities are limited; there are 35.12% physical or emotional health problems affecting social activities; there are 13.01% incapable perform activities of daily living.
The aim of this study was to explore the effectiveness of LED phototherapy on physiological symptoms among elderly in long-term care institutions in Taiwan. To examine the effects of physiological symptoms, such as mental state, muscle bone system, metabolism, autonomic balance and other meridian energy tests, it is expected to improve the body energy of healthy and sub-healthy elderly to increasing physical activity perform daily functions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaohsiung, Taiwan, 811
- Chong-En Group Long-term Care Center for the Elderly
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consciousness clear;must be able to talk
Exclusion Criteria:
- Clinical diagnosis of dementia;Seasonal mood disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Phototherapy protocol
Pretest:Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs. Intervention:LED light therapy for 6 weeks, 2-3 times a week, every 30 minutes. Post test:Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs. |
Pretest:Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs. Intervention:LED light therapy for 6 weeks, 2-3 times a week, every 30 minutes. Post test:Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index/PSQI
Time Frame: Change before, through intervention completion (average 6 weeks).
|
Insomnia was measured by the Pittsburgh Sleep Quality Index (PSQI), Global PSQI >5 score,good sleep;Global PSQI ≦5 score,poor sleep。
|
Change before, through intervention completion (average 6 weeks).
|
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time Frame: Change before, through intervention completion (average 6 weeks).
|
Fatigue was measured by the Brief Fatigue Inventory-Taiwanese (BFI-T), BFI-T=0 score,no fatigue;1~3 score,A little tired (not tired most of the time);4~6 score,Ordinary tired, tolerable (about half the time to feel tired);7~9 score,very tired (most of the time feel tired);10 score,most tired (I feel tired all the time)。
|
Change before, through intervention completion (average 6 weeks).
|
Cold Limbs
Time Frame: Change before, through intervention completion (average 6 weeks).
|
Cold Limbs was measured by the Yes / No Questionnaire elderly subjective feeling, "Yes" in the questionnaire means cold limbs;"No" in the questionnaire means no cold limbs。
|
Change before, through intervention completion (average 6 weeks).
|
Braden-Pressure ulcer risk factor assessment scale
Time Frame: Change before, through intervention completion (average 6 weeks).
|
Pressure ulcer was measured by the Braden-Pressure ulcer risk factor assessment scale, ≧16 score,Low-risk;12-15 score,Moderate risk;≦11 score,High-risk。
|
Change before, through intervention completion (average 6 weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Meridian Energy
Time Frame: Measured 1 week before and 1, 4, 6 weeks after intervention
|
Meridian energy was examined by using the Meridian Energy Analysis Device(M.E.A.D.), Parameters and normal values:Mental health status:0.78-1.09;Musculoskeletal
status:0.88-1.14;Metabolism
status:0.82-1.24;Autonomic
nervous system status:1.0-1.5;Overall
energy:28-64。
|
Measured 1 week before and 1, 4, 6 weeks after intervention
|
HRV
Time Frame: Measured 1 week before and 1, 4, 6 weeks after intervention
|
Autonomic nervous system activity was examined by using the Heart Rate Variability (HRV), Parameters and normal values:Low Frequency power(LF):0.04~0.15
Hz;High Frequency power(HF):0.15~-0.4
Hz;Standard deviation(SD):All normal to normal intervals, the larger the SD, the greater the HRV;mean Heart Rate;LF/HF ratio。
|
Measured 1 week before and 1, 4, 6 weeks after intervention
|
Body Temperature
Time Frame: Measured 1 week before and 1, 4, 6 weeks after intervention
|
Cold Limbs was measured by the body temperature (BT), Ear temperature measurement normal BT 36 ~ 37.5。
|
Measured 1 week before and 1, 4, 6 weeks after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YM108088E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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