NCT05788380

Brief Summary

Objective: This study aimed to investigate the effects of regular exercising on scapular muscle endurance and shoulder pain in young individuals. Methods: Participants' clinical and sociodemographic properties recorded, scapular muscle endurance assessed with Scapular Muscular Endurance (SME) test, and shoulder pain severity questioned using the Visual Analogue Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

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

April 15, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

March 14, 2023

Last Update Submit

March 25, 2023

Conditions

Keywords

Scapular Muscle EnduranceShoulder PainRegular ExercisingExercising

Outcome Measures

Primary Outcomes (2)

  • The Scapular Muscles Endurance (SME) test

    The Scapular Muscles Endurance (SME) test was used to assess the endurance of the Serratus Anterior muscles. For this test, the participant stood against the wall with their shoulders and elbows flexed to 900. There was no contact between the participant's arms and the wall. The subjects then held a green elastic exercise band (with a resistance of 2.3 kg, when stretched 100%), and an adjustable ruler was placed between their elbows to maintain the test position. While both scapulae were neutrally positioned, the participant was then asked to externally rotate the shoulders and to maintain this force for as long as they could hold and the holding duration was recorded in second. The test was ended when the participant was unable to maintain the resistance and dropped the adjustable ruler, failed to maintain 900 of shoulder flexion, or reported an unacceptable increase in discomfort (Edmondston et al. 2008).

    Evaluation was done at the first meeting with the participants.

  • Vizual Analog Scale

    measures pain severity in the affected shoulder from 0 to 10 points, with 0 points representing no pain at all and 10 points representing pain as bad as it can be

    Evaluation was done at the first meeting with the participants.

Study Arms (2)

The Scapular Muscles Endurance (SME

OTHER

The Scapular Muscles Endurance (SME) test was used to assess the endurance of the Serratus Anterior muscles.

Other: EXERCİSE

Vizual Analog Scale

OTHER

The VAS for pain, measures pain severity in the affected shoulder from 0 to 10 points, with 0 points representing no pain at all and 10 points representing pain as bad as it can be

Other: EXERCİSE

Interventions

EXERCISE FOR HEALTH AND PAIN IMPROVEMENT

The Scapular Muscles Endurance (SMEVizual Analog Scale

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • for exercise group;
  • between 17-25 years ages
  • who were using the fitness center by their preference (not professional)
  • had active sporting life (not professional)
  • who were regularly exercising
  • for sedentary group;
  • between 17-25 years ages
  • who had sedentary life style

You may not qualify if:

  • for boths group;
  • Individuals who had surgical stabilization,
  • who had previous shoulder complex fractures
  • who had positive impingement test results
  • who had systemic diseases
  • who had neurological and orthopedic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz Dengiz

Denizli, Pamukkale, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Collagen DiseasesShoulder Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Nilüfer çetişli korkmaz, Prof. Dr.

    Pamukkale University

    STUDY DIRECTOR
  • Esra Doğru HUZMELİ, Assoc Prof

    Mustafa kemalU

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In total, 200 individuals aged between 17-25 years, who had no neurological and orthopedic problems participated. Individuals who had surgical stabilization, previous shoulder complex fractures, positive impingement test results, and systemic diseases were excluded. Participants were categorized into the Regular Exercising (n = 100) and Sedentary (n = 100) Groups. The young adults who were using the fitness center by their preference (unprofessional), and who were regularly exercising, were included in the Regular Exercising Group. The volunteer young adults who were not exercising were included in the Sedentary Group. All participants gave written-informed consent before participation, and the study protocol conformed to the standards for human experiments set by the Declaration of Helsinki and was approved by Ethics Committee for Human Investigations of Mustafa Kemal University Ethics Committee (4298783/05022/4).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 28, 2023

Study Start

April 15, 2018

Primary Completion

July 20, 2021

Study Completion

January 15, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations