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

NCT04202900 | Completed DMC

• 1 other identifier: YM108088E
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Level Light Therapy

Keywords

elderly; LED phototherapy; meridian energy; sleep quality; fatigue; cold limbs; long-term care institution

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• 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 Outcomes (3)

• Meridian Energy

  Measured 1 week before and 1, 4, 6 weeks after intervention

• HRV

  Measured 1 week before and 1, 4, 6 weeks after intervention

• Body Temperature

  Measured 1 week before and 1, 4, 6 weeks after intervention

Study Arms (1)

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.

Other: phototherapy protocol

Interventions

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.

Phototherapy protocol

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Consciousness clear；must be able to talk

You may not qualify if:

• Clinical diagnosis of dementia；Seasonal mood disorder

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

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

Kaohsiung City, 811, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: September 11, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)