NCT06137534

Brief Summary

The study will be carried out with healthy students between the ages of 18-25 years who are studying at Ege University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation and who voluntarily agree to participate in the study. Informed consent form will be signed before the evaluation of the individuals. The study will be carried out as a single group with the inclusion of a total of 20 individuals. The students who volunteered to participate in the study will actively apply the selected PNF upper extremity patterns for 4 weeks and will be evaluated twice, before and after the application. Demographic information of the individuals; age, height, weight, gender, background, surname, smoking habit, alcohol habit, education level (class), sports habit, COVID-19 disease status and when it occurred will be recorded. Cosmed pulmonary function test device will be used to evaluate the respiratory function of the individuals, Oncomed brand electronic body weight and height measurement device will be used to calculate the body mass index. Body Image Perception Scale will be used for body image perception, Beck Depression Inventory will be used to evaluate psychological status, and Rosenberg Self-Esteem Scale will be used to evaluate sense of self.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

Same day

First QC Date

November 10, 2023

Last Update Submit

February 15, 2024

Conditions

Keywords

Reathing exercisesBody ImageDepressionProprioceptive Neuromuscular Facilitation

Outcome Measures

Primary Outcomes (5)

  • Forced vital capacity (FVC)

    It will be evaluated with Cosmed pulmonary function test device. The test will be performed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The patient will be asked to take a deep breath in a sitting position and then exhale rapidly through the spirometer. Nasal clamp will be used during exhalation.

    At the beginning and at the end of 4 weeks of exercise.

  • Forced expiratory volume in the first second (FEV1)

    It will be evaluated with Cosmed pulmonary function test device. The test will be performed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The patient will be asked to take a deep breath in a sitting position and then exhale rapidly through the spirometer. Nasal clamp will be used during exhalation.

    At the beginning and at the end of 4 weeks of exercise.

  • Forced expiratory volume in the first second/Forced vital capacity (FEV1/FVC)

    It will be evaluated with Cosmed pulmonary function test device. The test will be performed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The patient will be asked to take a deep breath in a sitting position and then exhale rapidly through the spirometer. Nasal clamp will be used during exhalation.

    At the beginning and at the end of 4 weeks of exercise.

  • Forced expiratory flow between 25% and 75% of vital capacity (FEF25-75)

    It will be evaluated with Cosmed pulmonary function test device. The test will be performed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The patient will be asked to take a deep breath in a sitting position and then exhale rapidly through the spirometer. Nasal clamp will be used during exhalation.

    At the beginning and at the end of 4 weeks of exercise.

  • Body Image Perception Scale

    The scale provides information about body image. The scale assesses satisfaction with 40 different body parts and functions. The scale has a minimum score of 40 and a maximum score of 200. A higher overall score on the scale indicates a higher negative judgement, while a lower overall score suggests a more positive evaluation.

    At the beginning and at the end of 4 weeks of exercise.

Secondary Outcomes (2)

  • Rosenberg Self-Esteem Scale

    At the beginning and at the end of 4 weeks of exercise.

  • Beck Depression Inventory

    At the beginning and at the end of 4 weeks of exercise.

Study Arms (1)

Exercise Group

EXPERIMENTAL

Proprioceptive neuromuscular facilitation upper extremity pattern exercises will be actively applied to 20 individuals in groups of 5 in a standing position for 30 minutes in each session 3 days a week for 4 weeks.

Other: Proprioceptive Neuromuscular Facilitation Upper Extremity Pattern

Interventions

Proprioceptive neuromuscular facilitation upper extremity pattern exercises will be actively applied to 20 individuals in groups of 5 in a standing position for 30 minutes in each session 3 days a week for 4 weeks. PNF upper extremity patterns to be applied to the participants: 1. Bilateral symmetrical flexion-adduction-external rotation. 2. Bilateral symmetrical flexion-abduction-external rotation. 3. Bilateral asymmetric right: flexion-abduction-external rotation, left: flexion-adduction-external rotation. 4. Bilateral reciprocal (same diagonal) right: extension-adduction-internal rotation, left: flexion-abduction-external rotation. 5. Bilateral reciprocal (same diagonal) right: flexion-adduction-external rotation, left: extension-abduction-internal rotation. 6. Bilateral reciprocal (opposite diagonal) right: extension-adduction-internal rotation, left: flexion, adduction, external rotation.

Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Not diagnosed with any chronic disease
  • No neurological problems
  • Has not had COVID-19 for at least 6 months

You may not qualify if:

  • Diagnosed with respiratory system diseases
  • Regular medication use
  • Suspected pregnancy
  • Individuals with rheumatic or neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Karsıyaka, 35550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The researcher who performed the evaluation did not participate in the exercise sessions applied in the study. He/she does not have information about the application.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: It includes a single-group exercise application with volunteer healthy university students.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 18, 2023

Study Start

November 10, 2023

Primary Completion

November 10, 2023

Study Completion

January 10, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

The study protocol and the data repository containing the participants' data can be requested from the principal investigator upon valid requests. The corresponding author can be reached via e-mail.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Accessible for two years from the end of the study.

Locations