The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain

The Effect of Aerobic Exercise on Pain, Alexithymia Level and Quality of Life 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Chronic Pain; Alexithymia
• Intervention / Treatment: Other: Aerobic Exercise

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey
      • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain levels	Pain levels will be assessed on the VAS before and after work.	Change from Baseline pain after 8 week exercise
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

Collaborators and Investigators

• Sponsor: KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pain; Neurologic Manifestations; Chronic Pain; Affective Symptoms
• Other Study ID Numbers: KaratayUH5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No