DepressionEXQUALITYNCT05342142
Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
A study testing Aerobic and ResistanceExercise in people with Depression and Alexithymia, 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 investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Alexithymia, Quality of Life
- What is being tested?
- Aerobic and ResistanceExercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2022to 30 Jun 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 (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician.
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, 1 recruiting
- Recruiting
Sultan Abdülhamid Training and Research Hospital
Istanbul, Uskudar, 34366
Elif Yıldırım Ayaz, M.D., +905325148300, drelifyildirim@hotmail.com
About this study
Official title: Effects of 12-week Aerobic and Resistance Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.
Read the detailed description
In this study, investigators hypothesized that aerobic and resistance exercises can increase the quality of life of elderly individuals by reducing their depression and alexithymia levels. The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.
- Conditions
- Depression, Alexithymia, Quality of Life, Physical Inactivity
- Being tested
- Aerobic and ResistanceExercise
- Keywords
- Depression, Alexithymia, Quality of Life, Elderly, Exercise
- Medical subject headings
- Depression, Affective Symptoms, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and ResistanceExerciseBehavioural
Exercise program consisting of 12 weeks of aerobic and resistance exercises
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Exercise program consisting of 12 weeks of aerobic and resistance exercises Receives: Behavioral: Aerobic and ResistanceExercise |
| Control | No intervention | No intervention will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
depression level as measured by the geriatric depression scale (min:0, max:15, 5 or more means more depression)
Measured: 1 week
Alexythimia
Alexythimia level as measured by the toronto Alexythimia scale (min:0, max:100, 61 ore more means more alexythimia)
Measured: 1 week
quality of life
level of quality of life measured by health related quality of life scale(min:24, max:120, high levels means low quality of life)
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 posted22 Apr 2022
- Study start23 Feb 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
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
- NCT05342142
- Sponsor's protocol ID
- EXQUALITY
- Acronym
- EXQUALITY
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mete E, Benli RK, Cinbaz G, Karacan E, Ayaz EY, Dincer B, Yanik A. Green Exercise for Emotional Health: Effects on Alexithymia, Depression, and Quality of Life in Older Adults-A Randomised Controlled Trial. Psychogeriatrics. 2026 Mar;26(2):e70146. doi: 10.1111/psyg.70146.
PubMed 41738474
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-week Aerobic and Resistance Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT05342142
- Acronym / sponsor ID
- EXQUALITY / EXQUALITY
- Conditions
- Depression, Alexithymia, Quality of Life, Physical Inactivity
- Keywords
- Depression, Alexithymia, Quality of Life, Elderly, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 22 Apr 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 investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.
Detailed description
In this study, investigators hypothesized that aerobic and resistance exercises can increase the quality of life of elderly individuals by reducing their depression and alexithymia levels. The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Aerobic and ResistanceExerciseExercise program consisting of 12 weeks of aerobic and resistance exercises |
| Control | No intervention | –No intervention will be made |
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 |
|---|---|---|
| Aerobic and ResistanceExerciseExercise program consisting of 12 weeks of aerobic and resistance exercises | Behavioural | Exercise |
Primary outcome
Depression
Time frame: 1 week
depression level as measured by the geriatric depression scale (min:0, max:15, 5 or more means more depression)
Alexythimia
Time frame: 1 week
Alexythimia level as measured by the toronto Alexythimia scale (min:0, max:100, 61 ore more means more alexythimia)
quality of life
Time frame: 1 week
level of quality of life measured by health related quality of life scale(min:24, max:120, high levels means low quality of life)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 41738474Mete E, Benli RK, Cinbaz G, Karacan E, Ayaz EY, Dincer B, Yanik A. Green Exercise for Emotional Health: Effects on Alexithymia, Depression, and Quality of Life in Older Adults-A Randomised Controlled Trial. Psychogeriatrics. 2026 Mar;26(2):e70146. doi: 10.1111/psyg.70146.
- 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 Aerobic and ResistanceExercise in people with Depression and Alexithymia, 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Yıldırım Ayaz, M.D. (+905325148300, drelifyildirim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342142, which also lists 1 linked publication.
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 22 Apr 2022.