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Completed

NCT Number: NCT05460806

The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain

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.

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Key information

Conditions

Chronic Pain Affective Symptoms Alexithymia Behavior Behavioral Symptoms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

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.

Primary outcomes

  1. Alexithymia

    Time frame: Change from Baseline Alexithymia after 8 week exercise

    Alexithymia levels will be assessed on the Toronto Alexithymia Scale-20 before and after work.

Secondary outcomes

  1. Pain levels

    Time frame: Change from Baseline pain after 8 week exercise

    Pain levels will be assessed on the VAS before and after work.

  2. Quality of Life levels

    Time frame: Change from Baseline quality of life after 8 week exercise

    Quality of life levels will be assessed on the SF36 before and after work.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

The Effect of Aerobic Exercise on Pain, Alexithymia Level and Quality of Life in Alexithymic Individuals With Chronic Pain

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2022
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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