NCT05723302

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 20, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2019

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

February 3, 2023

Last Update Submit

February 3, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • HADS

    Hospital Anxiety Depression Scale

    10 minutes

Secondary Outcomes (1)

  • SGRQ

    15 minutes

Study Arms (2)

Maximal Inspiratory Pressure

EXPERIMENTAL

MIP Maximal Inspiratory Pressure

Diagnostic Test: MIP/MEP

Maximal Expiratory Pressure

EXPERIMENTAL

MEP Maximal Expiratory Pressure

Diagnostic Test: MIP/MEP

Interventions

MIP/MEPDIAGNOSTIC_TEST

MIP/MEP

Maximal Expiratory PressureMaximal Inspiratory Pressure

Eligibility Criteria

Age38 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mehmet Akif Ersoy State Hospital

Çanakkale, 17100, Turkey (Türkiye)

Location

Çanakkale Onsekiz Mart University

Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 10, 2023

Study Start

January 20, 2017

Primary Completion

March 17, 2019

Study Completion

December 1, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)