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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
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Depression, Alexithymia, Quality of Life, Elderly, Exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 12, 2022
Last Updated
April 18, 2022
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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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

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Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals

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