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NCT Number: NCT04202900

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

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.

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Key information

Conditions

Low Level Light Therapy Dyssomnias Fatigue Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chong-En Group Long-term Care Center for the Elderly

Kaohsiung City, 811, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consciousness clear；must be able to talk

Exclusion criteria

  • Clinical diagnosis of dementia；Seasonal mood disorder

Treatment and study plan

phototherapy protocol

Other

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.

Primary outcomes

  1. 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。

  2. 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)。

  3. 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。

  4. 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。

Secondary outcomes

  1. 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。

  2. 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。

  3. 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。

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2019
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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