The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain

Sponsor
KTO Karatay University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05460806
Collaborator
(none)
40
1
2
1.9
21.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Aerobic Exercise on Pain, Alexithymia Level and Quality of Life in Alexithymic Individuals With Chronic Pain
Actual Study Start Date :
Jul 12, 2022
Anticipated Primary Completion Date :
Sep 6, 2022
Anticipated Study Completion Date :
Sep 7, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Alexithymia [Change from Baseline Alexithymia after 8 week exercise]

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

Secondary Outcome Measures

  1. Pain levels [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 [Change from Baseline quality of life after 8 week exercise]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KTO Karatay University Konya Karatay Turkey

Sponsors and Collaborators

  • KTO Karatay University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KTO Karatay University
ClinicalTrials.gov Identifier:
NCT05460806
Other Study ID Numbers:
  • KaratayUH5
First Posted:
Jul 15, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022