NCT06388876

Brief Summary

Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 22, 2024

Last Update Submit

April 24, 2024

Conditions

Keywords

natural disasterearthquakeexercisepost-traumatic stress disordersleep qualityphysiotherapy and rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Post-traumatic Stress Disorder Short Scale

    This self-report Likert-type scale was developed by LeBeau et al. in order to assess post-traumatic stress symptoms. The scale consists of nine questions and a single dimension. Each question is scored between 0 for "Not at all" and 4 for "Extremely". Total possible scores range between 0 and 36. The higher the total score, the higher the level of Post-traumatic Stress Disorder . The cut-off value of the scale was calculated as 24

    6 weeks

  • Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index consists of 24 questions and seven categories that yield information about the type and severity of sleep disturbance experienced in the past month. The Pittsburgh Sleep Quality Index includes questions assessing sleep quality, transition time, duration, efficiency, disturbance, sleep medication use, and daytime dysfunction due to sleep problems. Each item is scored from 0 (no distress at all) to 3 (severe distress). Total possible scores range from 0 to 21. A higher score means poorer sleep quality. A total score of 0-5 is regarded as indicating healthy sleep, 6-10 as poor sleep, and above 10 as long-term sleep disturbance.

    6 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise group did aerobic exercise during 6 weeks. Also this group took advice including lifestyle.

Other: ExerciseOther: lifestyle advice

control

EXPERIMENTAL

Control group only took advice including lifestyle.

Other: lifestyle advice

Interventions

Members of the exercise group received an exercise intervention twice a week for six weeks accompanied by a physiotherapist.

Also known as: lifestyle advice
Exercise

At the beginning of the program, the members of the individuals were given lifestyle recommendations, both verbally and in writing (in the form of a brochure) within the scope of a common training initiative.The individuals groups received both written (brochure) and verbal training within the scope of lifestyle recommendations (the effects of planned and regular exercise, sleep problems, methods of coping with stress, etc.).

Exercisecontrol

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-30
  • being directly affected by the earthquake in Mardin
  • providing voluntary consent to participating in the study

You may not qualify if:

  • involvement in an existing active regular exercise program
  • the presence a physical problem capable of preventing exercise
  • the presence of severe psychiatric disorders or cognitive and/or perceptual problems
  • regular use of sedative or neuropsychiatric drugs
  • active alcohol or drug addiction
  • missing assessment parameters
  • failure to participate in the intervention programs, or not continuing wıth the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazıt University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticMotor ActivitySleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • bahar külünkoğlu, assoc. prof.

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: there are 2 groups; exercise and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 29, 2024

Study Start

April 1, 2023

Primary Completion

June 15, 2023

Study Completion

July 30, 2023

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations