Low Level Light TherapyNCT04202900
Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions
A study testing phototherapy protocol in people with Low Level Light Therapy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Level Light Therapy
- What is being tested?
- phototherapy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Consciousness clear；must be able to talk
Who cannot join
- Clinical diagnosis of dementia；Seasonal mood disorder
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chong-En Group Long-term Care Center for the Elderly
Kaohsiung City, 811
About this study
Official title: Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions and Its Translation Application
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.
Read the 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.
- Conditions
- Low Level Light Therapy
- Being tested
- phototherapy protocol
- Keywords
- elderly, LED phototherapy, meridian energy, sleep quality, fatigue, cold limbs, long-term care institution
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapy protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: phototherapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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。
Measured: Change before, through intervention completion (average 6 weeks).
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)。
Measured: Change before, through intervention completion (average 6 weeks).
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。
Measured: Change before, through intervention completion (average 6 weeks).
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。
Measured: Change before, through intervention completion (average 6 weeks).
Secondary outcomes (3)
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: Measured 1 week before and 1, 4, 6 weeks after intervention
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: Measured 1 week before and 1, 4, 6 weeks after intervention
Body Temperature
Cold Limbs was measured by the body temperature (BT), Ear temperature measurement normal BT 36 ~ 37.5。
Measured: Measured 1 week before and 1, 4, 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start11 Sep 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Light TherapyStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202900
- Sponsor's protocol ID
- YM108088E
- Status last verified
- Mar 2023
- First submitted
- 16 Dec 2019
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions and Its Translation Application
- ClinicalTrials.gov ID
- NCT04202900
- Acronym / sponsor ID
- YM108088E
- Conditions
- Low Level Light Therapy
- Keywords
- elderly, LED phototherapy, meridian energy, sleep quality, fatigue, cold limbs, long-term care institution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phototherapy protocol | Other | Other: phototherapy protocolPretest：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. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Consciousness clear；must be able to talk
Key exclusion criteria (1 listed)
- Clinical diagnosis of dementia；Seasonal mood disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phototherapy protocolPretest：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. | Other | Phototherapy protocol |
Primary outcome
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。
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)。
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。
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。
3 secondary outcomes
Meridian Energy
Time frame: 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
Body Temperature
Time frame: Measured 1 week before and 1, 4, 6 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phototherapy protocol in people with Low Level Light Therapy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index/PSQI (time frame: Change before, through intervention completion (average 6 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.