Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals (EXQUALITY)
Primary Purpose
Depression, Alexithymia, Quality of Life
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic and ResistanceExercise
Sponsored by
About this trial
This is an interventional other trial for Depression focused on measuring Depression, Alexithymia, Quality of Life, Elderly, Exercise
Eligibility Criteria
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
Sites / Locations
- Sultan Abdülhamid Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Exercise
Control
Arm Description
Exercise program consisting of 12 weeks of aerobic and resistance exercises
No intervention will be made
Outcomes
Primary Outcome Measures
Depression
depression level as measured by the geriatric depression scale (min:0, max:15, 5 or more means more depression)
Alexythimia
Alexythimia level as measured by the toronto Alexythimia scale (min:0, max:100, 61 ore more means more alexythimia)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05342142
First Posted
April 12, 2022
Last Updated
April 18, 2022
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05342142
Brief Title
Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
Acronym
EXQUALITY
Official Title
Effects of 12-week Aerobic and Resistance Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Alexithymia, Quality of Life, Physical Inactivity
Keywords
Depression, Alexithymia, Quality of Life, Elderly, Exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Exercise program consisting of 12 weeks of aerobic and resistance exercises
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be made
Intervention Type
Behavioral
Intervention Name(s)
Aerobic and ResistanceExercise
Intervention Description
Exercise program consisting of 12 weeks of aerobic and resistance exercises
Primary Outcome Measure Information:
Title
Depression
Description
depression level as measured by the geriatric depression scale (min:0, max:15, 5 or more means more depression)
Time Frame
1 week
Title
Alexythimia
Description
Alexythimia level as measured by the toronto Alexythimia scale (min:0, max:100, 61 ore more means more alexythimia)
Time Frame
1 week
Title
quality of life
Description
level of quality of life measured by health related quality of life scale(min:24, max:120, high levels means low quality of life)
Time Frame
1 week
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
65 years and over
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Organizational Affiliation
Sultan Abdülhamid Training And Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Abdülhamid Training and Research Hospital
City
Istanbul
State/Province
Uskudar
ZIP/Postal Code
34366
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
We'll reach out to this number within 24 hrs