AgingNCT03304301
Effect of Sunlight Exposure and Outdoor Activities on Depression, Cognition and Quality of Life in the Elderly
A study testing sunlight exposure in people with Aging and Nursing Homes, run by Chiayi Christian Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Nursing Homes, Depression in Old Age
- What is being tested?
- sunlight exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jun 2016to 12 Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- allergy to sunlight
- diagnosed with skin cancer
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
BaoKang Long-Term Care Center
Chiayi City
TZU-CHIA LIN, Master
About this study
Official title: 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.
Read more
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.
- Being tested
- sunlight exposure
- Keywords
- sunlight exposure, institutionalized elderly, depression, quality of life, cognition function
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunlight exposureBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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. Receives: Behavioral: sunlight exposure |
| control group | No intervention | Participants will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline depression at 3 months
measured with GDS-15
Measured: baseline, three month after recruitment
Secondary outcomes (1)
Change from baseline cognitive function at 3 months
measured with SPMSQ
Measured: baseline, three month after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start30 Jun 2016
- Primary completion12 Jan 2018 (estimated)
- Study completion12 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng Kung University
- Responsible party
- Sponsor
- Investigators
- LIN TZUCHIA, MASTER, Principal investigator, Chiayi christian hospital, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304301
- Sponsor's protocol ID
- 104114
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sunlight Exposure and Outdoor Activities on Improving the Depression, Cognition and Quality of Life of the Institutionalized Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03304301
- Acronym / sponsor ID
- 104114
- Keywords
- sunlight exposure, institutionalized elderly, depression, quality of life, cognition function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Collaborators
- National Cheng Kung University
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 12 Jan 2018 (estimated)
- Study completion
- 12 Apr 2018 (estimated)
- First posted
- 9 Oct 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: sunlight exposureParticipants 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. |
| control group | No intervention | –Participants will receive routine care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- allergy to sunlight
- diagnosed with skin cancer
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 |
|---|---|---|
| sunlight exposureParticipants 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 | Behavioural | experimental group |
Primary outcome
Change from baseline depression at 3 months
Time frame: baseline, three month after recruitment
measured with GDS-15
1 secondary outcome
Change from baseline cognitive function at 3 months
Time frame: baseline, three month after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
LIN TZUCHIA, MASTER principal investigator
Chiayi christian hospital, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunlight exposure in people with Aging and Nursing Homes, run by Chiayi Christian Hospital 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TZU-CHIA LIN, Master (+886-5-2765041 ext. 1256, 11518@cych.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depression at 3 months (time frame: baseline, three month after recruitment). 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 10 Oct 2017.