Sleep DisorderEXDESNCT05418283
Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals
A study testing Exercise in people with Sleep Disorder and Depressive Disorder, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Depressive Disorder, Death
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 30 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals aged 65 and over who volunteered to participate in the study,
- Conscious and without communication problems,
- No orthopedic injury that prevents walking
- Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
- Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
- Being eligible to participate in an exercise program after a cardiac examination by a cardiologist (resting ECG and questioning of cardiac symptoms, further examinations such as exercise ECG test if necessary)
Who cannot join
- Having a history of neuromuscular disease
- Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
- Less than 1 year life expectancy
- Having an orthopedic injury that prevents walking
- Presence of advanced sensory deficit
- Having visual and hearing problems
Show all 10Show fewer
- Not having sufficient communication skills (Mini Mental Test score below 24 points)
- Not having agreed to participate in the study
- Uncontrolled hypertension
- Not being found suitable for exercise in the examination performed by physicians and physiotherapists
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdülhamid Training and Research Hospital
Üsküdar, Istanbul, 34660
About this study
The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.
Read the detailed description
The effect of regular exercise programs on fear of death in elderly individuals is unknown. The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.
- Conditions
- Sleep Disorder, Depressive Disorder, Death, Physical Inactivity
- Being tested
- Exercise
- Keywords
- sleep disorder, fear of death, exercise, Elderly
- Medical subject headings
- Sleep Wake Disorders, Depressive Disorder, Death, Sedentary Behavior, Necrophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
1 hour of aerobic exercise will be applied 3 days a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | 12-week aerobic exercise program will be applied (3/week) Receives: Behavioral: Exercise |
| Control | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thanatophobia
evaluation of thanatophobia
Measured: 1 week
Secondary outcomes (1)
sleep quality
evaluation of sleep quality
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start10 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif Yıldırım Ayaz, M.D., Principal investigator, Sultan Abdülhamid Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418283
- Sponsor's protocol ID
- EXDES
- Acronym
- EXDES
- Status last verified
- Apr 2023
- First submitted
- 9 Jun 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT05418283
- Acronym / sponsor ID
- EXDES / EXDES
- Conditions
- Sleep Disorder, Depressive Disorder, Death, Physical Inactivity
- Keywords
- sleep disorder, fear of death, exercise, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 14 Jun 2022 (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 aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.
Detailed description
The effect of regular exercise programs on fear of death in elderly individuals is unknown. The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Exercise12-week aerobic exercise program will be applied (3/week) |
| Control | No intervention | –No intervention will be applied. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Individuals aged 65 and over who volunteered to participate in the study,
- Conscious and without communication problems,
- No orthopedic injury that prevents walking
- Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
- Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
Key exclusion criteria (10 listed)
- Having a history of neuromuscular disease
- Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
- Less than 1 year life expectancy
- Having an orthopedic injury that prevents walking
- Presence of advanced sensory deficit
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 |
|---|---|---|
| Exercise1 hour of aerobic exercise will be applied 3 days a week for 12 weeks. | Behavioural | Exercise |
Primary outcome
thanatophobia
Time frame: 1 week
evaluation of thanatophobia
1 secondary outcome
sleep quality
Time frame: 1 week
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 12 Apr 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.
Elif Yıldırım Ayaz, M.D. principal investigator
Sultan Abdülhamid Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sleep Disorder and Depressive Disorder, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 6 inclusion and 10 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 12 Apr 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 Turkey (Türkiye). 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?
thanatophobia (time frame: 1 week). 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 12 Apr 2023.