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Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals (EXDES)

Primary Purpose

Sleep Disorder, Depressive Disorder, Death

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
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 treatment trial for Sleep Disorder focused on measuring sleep disorder, fear of death, exercise, Elderly

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 by a cardiologist (resting ECG and questioning of cardiac symptoms, further examinations such as exercise ECG test if necessary)

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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise

Control

Arm Description

12-week aerobic exercise program will be applied (3/week)

No intervention will be applied.

Outcomes

Primary Outcome Measures

thanatophobia
evaluation of thanatophobia

Secondary Outcome Measures

sleep quality
evaluation of sleep quality

Full Information

First Posted
June 9, 2022
Last Updated
April 11, 2023
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05418283
Brief Title
Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals
Acronym
EXDES
Official Title
Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Depressive Disorder, Death, Physical Inactivity
Keywords
sleep disorder, fear of death, exercise, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
12-week aerobic exercise program will be applied (3/week)
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be applied.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
1 hour of aerobic exercise will be applied 3 days a week for 12 weeks.
Primary Outcome Measure Information:
Title
thanatophobia
Description
evaluation of thanatophobia
Time Frame
1 week
Secondary Outcome Measure Information:
Title
sleep quality
Description
evaluation of sleep quality
Time Frame
1 week

10. Eligibility

Sex
All
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 by a cardiologist (resting ECG and questioning of cardiac symptoms, further examinations such as exercise ECG test if necessary) 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
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
Üsküdar
State/Province
İstanbul
ZIP/Postal Code
34660
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals

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