NCT06706297

Brief Summary

Purpose of the research This research was designed to determine the effect of breathing exercise applied to individuals diagnosed with COPD on respiratory function, dyspnea and quality of life. Hypotheses of the Research H0a: Breathing exercise applied to individuals diagnosed with COPD has no effect on the respiratory function test FEV1/FVC. H1a: Breathing exercise applied to individuals diagnosed with COPD has an effect on the respiratory function test FEV1/FVC. H0b: Breathing exercise applied to individuals diagnosed with COPD has no effect on dyspnea. H1b: Breathing exercise applied to individuals diagnosed with COPD has an effect on dyspnea. H0c: Breathing exercise applied to individuals diagnosed with COPD has no effect on quality of life. H1c: Breathing exercise applied to individuals diagnosed with COPD has an effect on the quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

November 21, 2024

Last Update Submit

November 22, 2024

Conditions

Keywords

DyspneaCOPDBreathing ExercisePranayamaRespiratory FunctionQuality of Life.

Outcome Measures

Primary Outcomes (3)

  • pulmonary function test

    The effect of breathing exercise applied to individuals with COPD on respiratory function test FEV1/FVC

    6 weeks

  • Dyspnea severity

    The effect of breathing exercise applied to individuals with COPD on dyspnea

    6 weeks

  • Saint George's Solunum Anket

    The effect of breathing exercise applied to individuals with COPD on quality of life

    6 weeks

Study Arms (2)

control

NO INTERVENTION

Control group patients will not undergo any exercise and the normal clinical protocol will not be interfered with.

breathing exercise group

EXPERIMENTAL

The researcher will make the application group patients perform a 30-minute pranayama exercise twice a week for 6 weeks.

Other: pranayama breathing exercise

Interventions

Normal breathing, focusing on breathing, Alternative Nose Breathing, Cooling Breath, Bee Buzzing Sound, A breathing exercise of 20 minutes in total, consisting of 5 stages: normal breathing and focusing on breathing.

breathing exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with COPD for at least 1 year, confirmed by pulmonary function test
  • Those who voluntarily accepted to participate in the research
  • Those aged 18 and over,
  • Individuals who have access to the hospital

You may not qualify if:

  • In COPD exacerbation period,
  • Having a neurological or psychiatric diagnosis,
  • Those with obesity,
  • Those with physical disabilities (vision, hearing, walking, etc.),
  • Those who are pregnant,
  • Illiterate
  • Diagnosed with another disease that significantly affects the respiratory system (scoliosis, lung cancer, abdominal tumor, etc.).
  • Patients who have previously participated in an exercise program will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DyspneaPulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Aybike KÖSE, 1

    Ondokuz Mayıs University

    STUDY CHAIR
  • Afitap ÖZDELİKARA, 2

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research was planned as a prospective, randomized controlled, experimental type study with pretest-posttest measurements to determine the effect of breathing exercise on dyspnea, respiratory function and quality of life in patients with COPD.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Nurse,

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 26, 2024

Study Start

January 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 25, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations