NCT05460806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
Last Updated

October 12, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 13, 2022

Last Update Submit

October 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain levels

    Change from Baseline pain after 8 week exercise

  • Quality of Life levels

    Change from Baseline quality of life after 8 week exercise

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

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.

Aerobic Exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of any physiological or psychological disease that may interfere with the exercise protocol to be applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainAffective Symptoms

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 15, 2022

Study Start

July 12, 2022

Primary Completion

September 6, 2022

Study Completion

September 7, 2022

Last Updated

October 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations