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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05723302
Other study ID # IstanbulMUH_1999
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2017
Est. completion date December 1, 2022

Study information

Verified date February 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 1, 2022
Est. primary completion date March 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 38 Years to 67 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MIP/MEP
MIP/MEP

Locations

Country Name City State
Turkey Çanakkale Onsekiz Mart University Çanakkale
Turkey Mehmet Akif Ersoy State Hospital Çanakkale

Sponsors (3)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital Çanakkale Onsekiz Mart University, Mehmet Akif Ersoy Canakkale State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary HADS Hospital Anxiety Depression Scale 10 minutes
Secondary SGRQ St George's Respiratory Questionnaire 15 minutes
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