- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05723302
Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation
The Effect of Resistant Proprioceptive Neuromuscular Facilitation Exercises on Respiratory Muscle Strength in Chronic Obstructive Pulmonary Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was carried out between January 2017 and January 2019, with patients followed up with the diagnosis of COPD in Çanakkale Mehmet Akif Ersoy State Hospital and Çanakkale Onsekiz Mart University Medical Faculty Hospital, Department of Chest Diseases. It was approved by Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee (Date: 30.12.2016, Decision No. 573) and was done in accordance with the Declaration of Helsinki. All participants were informed about the purpose of the study, the total duration of treatment and the applications to be made, and a consent form was signed. The study was conducted as a prospective and randomized controlled study, and inclusion and exclusion criteria were determined.
Thirty-five patients diagnosed with COPD were referred to the study, four patients were excluded because they did not meet the inclusion criteria, and the study was conducted with a total of 31 participants.
The 31 patients included in the study were randomized after their initial evaluation and divided into two groups as experimental and control groups. Patients meeting the inclusion criteria were divided into 2 groups. Randomized by ordering by date of application.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Çanakkale, Turkey, 17100
- Mehmet Akif Ersoy State Hospital
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Çanakkale, Turkey, 17100
- Canakkale Onsekiz Mart University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To be diagnosed with stage 1, stage 2 and stage 3 COPD according to GOLD (Global Initiative for Obstructive Lung Diseases) criteria
- Having FEV1/FVC <70% according to pulmonary function test
- Being clinically stable
- Being over 18 years old
- Volunteer to participate in the program
Exclusion Criteria:
- Having a COPD exacerbation in the last 8 weeks
- To have participated in a regular exercise training program in the last 1 year
- Having a musculoskeletal disease and neuromuscular disease that may prevent exercise
- Inability to cooperate for pulmonary function test and respiratory muscle strength measurement
- Being on long-term oxygen therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Maximal Inspiratory Pressure
MIP Maximal Inspiratory Pressure
|
MIP/MEP
|
|
EXPERIMENTAL: Maximal Expiratory Pressure
MEP Maximal Expiratory Pressure
|
MIP/MEP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HADS
Time Frame: 10 minutes
|
Hospital Anxiety Depression Scale
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SGRQ
Time Frame: 15 minutes
|
St George's Respiratory Questionnaire
|
15 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMUH_1999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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