- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06137534
Upper Extremity Pattern Exercises and Respiratory Functions
February 15, 2024 updated by: Ozden Gokcek, Ege University
The Effect of Proprioceptive Neuromuscular Facilitation Upper Extremity Pattern Exercises on Respiratory Functions, Body Image, Self-Esteem and Psychological State
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karsıyaka
-
Izmir, Karsıyaka, Turkey, 35550
- Ege University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Not diagnosed with any chronic disease
- No neurological problems
- Has not had COVID-19 for at least 6 months
Exclusion Criteria:
- Diagnosed with respiratory system diseases
- Regular medication use
- Suspected pregnancy
- Individuals with rheumatic or neurological diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Group
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced vital capacity (FVC)
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
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)
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
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)
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
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)
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
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
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rosenberg Self-Esteem Scale
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
The scale consists of 63 items.
It is evaluated over 12 subscales and it is accepted that those who score 0-1 on the self-esteem subscale have high self-esteem, those who score 2-4 have medium self-esteem and those who score 5-6 have low self-esteem.
|
At the beginning and at the end of 4 weeks of exercise.
|
|
Beck Depression Inventory
Time Frame: At the beginning and at the end of 4 weeks of exercise.
|
It is a scale developed to measure the behavioural findings of depression.
As a result of the scoring, 0-9 points are interpreted as Minimal, 10-16 points as Mild, 17-29 points as Moderate, 30-63 points as Severe.
|
At the beginning and at the end of 4 weeks of exercise.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2023
Primary Completion (Actual)
November 10, 2023
Study Completion (Actual)
January 10, 2024
Study Registration Dates
First Submitted
November 10, 2023
First Submitted That Met QC Criteria
November 15, 2023
First Posted (Actual)
November 18, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 08/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Accessible for two years from the end of the study.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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