NCT05418283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

June 9, 2022

Last Update Submit

April 11, 2023

Conditions

Keywords

sleep disorderfear of deathexerciseElderly

Outcome Measures

Primary Outcomes (1)

  • thanatophobia

    evaluation of thanatophobia

    1 week

Secondary Outcomes (1)

  • sleep quality

    1 week

Study Arms (2)

Exercise

ACTIVE COMPARATOR

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

Behavioral: Exercise

Control

NO INTERVENTION

No intervention will be applied.

Interventions

ExerciseBEHAVIORAL

1 hour of aerobic exercise will be applied 3 days a week for 12 weeks.

Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdülhamid Training and Research Hospital

Üsküdar, Istanbul, 34660, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Wake DisordersDepressive DisorderDeathSedentary BehaviorNecrophobiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersMood DisordersPathologic ProcessesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif Yıldırım Ayaz, M.D.

    Sultan Abdülhamid Training And Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 14, 2022

Study Start

June 10, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations