Back to resultsThe Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain
Primary Purpose
Chronic Pain, Quality of Life, Alexithymia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- KTO Karatay University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aerobic Exercise
Control
Arm Description
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.
Outcomes
Primary Outcome Measures
Alexithymia
Alexithymia levels will be assessed on the Toronto Alexithymia Scale-20 before and after work.
Secondary Outcome Measures
Pain levels
Pain levels will be assessed on the VAS before and after work.
Quality of Life levels
Quality of life levels will be assessed on the SF36 before and after work.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05460806
Brief Title
The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain
Official Title
The Effect of Aerobic Exercise on Pain, Alexithymia Level and Quality of Life in Alexithymic Individuals With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
September 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Quality of Life, Alexithymia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
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 Outcome Measure Information:
Title
Alexithymia
Description
Alexithymia levels will be assessed on the Toronto Alexithymia Scale-20 before and after work.
Time Frame
Change from Baseline Alexithymia after 8 week exercise
Secondary Outcome Measure Information:
Title
Pain levels
Description
Pain levels will be assessed on the VAS before and after work.
Time Frame
Change from Baseline pain after 8 week exercise
Title
Quality of Life levels
Description
Quality of life levels will be assessed on the SF36 before and after work.
Time Frame
Change from Baseline quality of life after 8 week exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Aerobic Exercise in Alexithymic Individuals With Chronic Pain
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