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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05460806
Other study ID # KaratayUH5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 12, 2022
Est. completion date September 7, 2022

Study information

Verified date July 2022
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It was aimed to investigate the effect of aerobic exercise on pain, alexithymia level and quality of life in young alexithymic individuals with chronic pain. There is no study in the literature comparing the effectiveness of aerobic exercise on alexithymia and chronic pain. Since our study will be the first study to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, it is planned to make national or international papers and publications after the study is completed.


Description:

In the study, after the necessary permissions are obtained, the Graded Chronic Pain Scale (ECAS) and Toronto Alexithymia Scale-20 (TAS-20) will be sent to the students who are studying at KTO Karatay University and whose age range is between 18-25 years. Among the students who fill out the form voluntarily, individuals who mark the 3rd or 4th option in the first question in the DKAS and who have a total score of 52 and above in the TAS-20 scale will be identified. Among these individuals, a total of 40 people will be included in the study randomly with a computer program. These participants will again be randomly divided into two groups as the control group (n=20) and the exercise group (n=20).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 7, 2022
Est. primary completion date September 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - To be between the ages of 18-25 - To mark the 3rd or 4th option in the first question in the DKAS - To have a TAS-20 total score of 61 and above Exclusion Criteria: - Presence of any physiological or psychological disease that may interfere with the exercise protocol to be applied

Study Design


Intervention

Other:
Aerobic Exercise
Participants assigned to aerobic exercise training will walk on a treadmill (RodbyTM, RL 1600E, Enhorna, Sweden) for 40 minutes at an intensity of 60-75% of maximum heart rate (220-age formula) three times per week for 8 weeks. The heart rate of the participants will be measured with an electric heart rate monitor throughout the session.

Locations

Country Name City State
Turkey KTO Karatay University Konya Karatay

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alexithymia Alexithymia levels will be assessed on the Toronto Alexithymia Scale-20 before and after work. Change from Baseline Alexithymia after 8 week exercise
Secondary Pain levels Pain levels will be assessed on the VAS before and after work. Change from Baseline pain after 8 week exercise
Secondary Quality of Life levels Quality of life levels will be assessed on the SF36 before and after work. Change from Baseline quality of life after 8 week exercise
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