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Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MIP/MEP
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

38 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mehmet Akif Ersoy State Hospital
  • Çanakkale Onsekiz Mart University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Maximal Inspiratory Pressure

Maximal Expiratory Pressure

Arm Description

MIP Maximal Inspiratory Pressure

MEP Maximal Expiratory Pressure

Outcomes

Primary Outcome Measures

HADS
Hospital Anxiety Depression Scale

Secondary Outcome Measures

SGRQ
St George's Respiratory Questionnaire

Full Information

First Posted
February 3, 2023
Last Updated
February 3, 2023
Sponsor
Istanbul Medipol University Hospital
Collaborators
Mehmet Akif Ersoy Canakkale State Hospital, Çanakkale Onsekiz Mart University
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1. Study Identification

Unique Protocol Identification Number
NCT05723302
Brief Title
Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation
Official Title
The Effect of Resistant Proprioceptive Neuromuscular Facilitation Exercises on Respiratory Muscle Strength in Chronic Obstructive Pulmonary Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
March 17, 2019 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
Collaborators
Mehmet Akif Ersoy Canakkale State Hospital, Çanakkale Onsekiz Mart University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maximal Inspiratory Pressure
Arm Type
Experimental
Arm Description
MIP Maximal Inspiratory Pressure
Arm Title
Maximal Expiratory Pressure
Arm Type
Experimental
Arm Description
MEP Maximal Expiratory Pressure
Intervention Type
Diagnostic Test
Intervention Name(s)
MIP/MEP
Intervention Description
MIP/MEP
Primary Outcome Measure Information:
Title
HADS
Description
Hospital Anxiety Depression Scale
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
SGRQ
Description
St George's Respiratory Questionnaire
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mehmet Akif Ersoy State Hospital
City
Çanakkale
ZIP/Postal Code
17100
Country
Turkey
Facility Name
Çanakkale Onsekiz Mart University
City
Çanakkale
ZIP/Postal Code
17100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation

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