- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304301
Effect of Sunlight Exposure and Outdoor Activities on Depression, Cognition and Quality of Life in the Elderly
Effect of Sunlight Exposure and Outdoor Activities on Improving the Depression, Cognition and Quality of Life of the Institutionalized Elderly: A Randomized Controlled Trial
Background: The transition to long-term care facility can be a stressful and emotional event for the elderly. The evidences showed that the prevalence of depression and the cognition impairment were higher in the institutionalized elderly than the community dwelling elderly. It could affect the quality of life of the elderly and increase risk of mortality.
Purpose: The aim of the study is to evaluate the effect of outdoor activities and sunlight exposure on depression, cognitive function, and quality of life among institutionalized elderly.
Method: The design is a randomized control trial. Participants will be randomly allocated to experimental or control groups by block randomization. In the experimental group, participants will be encouraged to reduce time spent on bed and bedroom. Nurses, nurse aids or family will take participants outdoors and exposure their face, hands or arm to sunlight for 15-30 minutes a day, five days a week for three months (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside). In the control group, the participants will receive routine care. The control group will neither be encouraged to stay outdoors nor limit the chance to exposure to sunlight.
Expected outcome: The expected benefit of the research is to improve the depression, cognitive function, and quality of life of the institutionalized elderly.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chia-Yi, Taiwan
- Recruiting
- BaoKang Long-Term Care Center
-
Contact:
- TZU-CHIA LIN, Master
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- resident in the long-term care facility for at least 6 months
- Barthel Index score is equal or over 20
- able to communicate
- life expectancy over 12 months
- conscious clear
Exclusion Criteria:
- allergy to sunlight
- diagnosed with skin cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
Participants will be encouraged to reduce time spent on bed and bedroom.
We will also take participants outdoors and expose to sunlight (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months.
|
Participants will be encouraged to reduce time spent on bed and bedroom.
We will also take participants outdoors and receiving sunlight exposure (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months
|
No Intervention: control group
Participants will receive routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline depression at 3 months
Time Frame: baseline, three month after recruitment
|
measured with GDS-15
|
baseline, three month after recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline cognitive function at 3 months
Time Frame: baseline, three month after recruitment
|
measured with SPMSQ
|
baseline, three month after recruitment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline quality of life at 3 months
Time Frame: baseline, three month after recruitment
|
measured with EQ-5D
|
baseline, three month after recruitment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: LIN TZUCHIA, MASTER, Chiayi christian hospital, Taiwan, R.O.C.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on sunlight exposure
-
Korea University Anam HospitalCompletedSunlight ExposureKorea, Republic of
-
Kafrelsheikh UniversityUnknown
-
Taipei Veterans General Hospital, TaiwanCompletedDepression | StrokeTaiwan
-
Seoul National University HospitalCompletedVitamin D Deficiency | Cardiometabolic Risk Factors
-
The Hospital for Sick ChildrenWithdrawn
-
University of MinnesotaThrasher Research FundCompletedFiltered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates (FSPT)Jaundice, NeonatalNigeria
-
University of MinnesotaThrasher Research FundCompletedJaundice, NeonatalNigeria
-
Yale UniversityCompletedAlzheimer's DiseaseUnited States
-
Chulalongkorn UniversityCompletedVitamin D Deficiency | End Stage Renal DiseaseThailand
-
Dartmouth-Hitchcock Medical CenterNorris Cotton Cancer CenterCompleted