Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions

Low Level Light Therapy Clinical Trial

Official title:

Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions and Its Translation Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202900
• Other study ID #: YM108088E
• Status: Completed
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The world is facing rapid population aging, the health needs of the elderly are complex, and their physical capabilities are degraded, and increased the possibility of having one or more chronic conditions. In 1900 to 2000, there were 7,600 million people in the United States, aged 65 and above age increased to 4.1% up to 12.6%, by 2050 is expected to increase 20.3%.In Taiwan, the elderly population have 83.5% is health and sub-health, in order to allow them to perform activities of daily living independently, in particular, need to pay attention to the diverse needs of the elderly, Assist the elderly to increase self-care skills, reduce disability is a very important issue.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• Consciousness clear;must be able to talk

Exclusion Criteria:

• Clinical diagnosis of dementia;Seasonal mood disorder

Related Conditions & MeSH terms

• Low Level Light Therapy

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chong-En Group Long-term Care Center for the Elderly	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index/PSQI	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).
Primary	Brief Fatigue Inventory-Taiwanese (BFI-T)	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).
Primary	Cold Limbs	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).
Primary	Braden-Pressure ulcer risk factor assessment scale	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	Meridian Energy	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
Secondary	HRV	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
Secondary	Body Temperature	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