- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05342142
Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals (EXQUALITY)
April 18, 2022 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uskudar
-
Istanbul, Uskudar, Turkey, 34366
- Recruiting
- Sultan Abdulhamid Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise
Exercise program consisting of 12 weeks of aerobic and resistance exercises
|
Exercise program consisting of 12 weeks of aerobic and resistance exercises
|
|
No Intervention: Control
No intervention will be made
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: 1 week
|
depression level as measured by the geriatric depression scale (min:0, max:15, 5 or more means more depression)
|
1 week
|
|
Alexythimia
Time Frame: 1 week
|
Alexythimia level as measured by the toronto Alexythimia scale (min:0, max:100, 61 ore more means more alexythimia)
|
1 week
|
|
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)
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elif Yıldırım Ayaz, M.D., Sultan Abdulhamid Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2022
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
April 12, 2022
First Submitted That Met QC Criteria
April 18, 2022
First Posted (Actual)
April 22, 2022
Study Record Updates
Last Update Posted (Actual)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 18, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXQUALITY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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