Skip to main content
OpenTrials
Completed

NCT Number: NCT06928805

The Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters

This study aims to determine the effects of balloon inflation and pursed-lip breathing exercises, in addition to the forward-leaning position, on physiological parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD).

The hypotheses of the study are as follows:

H1_1: The forward-leaning position and balloon inflation breathing exercise have a positive effect on physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD).

H1_2: The forward-leaning position and pursed-lip breathing exercise have a positive effect on physiological parameters in patients with COPD.

H1_3: There is a significant difference in physiological parameters between the balloon inflation and pursed-lip breathing exercise groups and the control group.

Within this scope, the study will be conducted with three groups:

Intervention Group 1: Balloon inflation exercise applied in addition to the forward-leaning position.

Intervention Group 2: Pursed-lip breathing exercise applied in addition to the forward-leaning position.

Control Group: Standard practice implemented in the institution where the study is conducted.

Participants:

* A home exercise program will be designed for both intervention groups, allowing them to perform the exercises independently each day. * The exercises will start with three sessions per day and will be increased by one session each week, continuing for a total of four weeks. * Participants will visit the outpatient clinic in the 4th week for assessments and tests. * Patients will be contacted weekly by the researcher via phone to ensure adherence to the program.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Turkey

Istanbul, Üsküdar, Turkey (Türkiye)

About this study

The exercise program will be determined in collaboration with a respiratory physiotherapist and implemented by the researcher. Accordingly, patients with stage II-III COPD (as determined by a physician) who visit the pulmonology outpatient clinic of the relevant hospital and meet the inclusion criteria will be given brief information about respiratory exercises, their benefits, and duration. They will then be instructed on how to perform the exercises through verbal commands for approximately 30 minutes. At the end of the session, the exercise guidelines will be practiced under the supervision of the researcher.

Before starting, the patient will be seated in a chair and allowed to rest for about 15 minutes. The patient will be informed about how to perform the walking test, the expected walking pace, and that they can stop and rest if they feel fatigued. Then, the patient will be asked to walk at a brisk pace for six minutes under the supervision of the researcher. During the walk, the researcher will continuously monitor the patient's oxygen saturation using a handheld pulse oximeter. If the patient exhibits signs of excessive sweating, pallor, or a significant drop in oxygen levels, the test will be terminated early.

Before and after the test, blood pressure, pulse rate, respiratory rate, oxygen saturation [SpO2], and dyspnea score using the Modified Borg Scale will be assessed, and the distance the patient walks in six minutes will be recorded. The six-minute walk test will be repeated at the end of the study. Subsequently, the patient will undergo a pulmonary function test, and the values for FVC, FEV1, FEV1/FVC ratio, and peak expiratory flow will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have no communication and cooperation problems,
  • Can speak and understand Turkish,
  • Have a baseline saturation of >90%,
  • Have been diagnosed with Stage II and Stage III COPD,
  • Have not had any infection or COPD exacerbation for at least 3 months,
  • Have not participated in a pulmonary rehabilitation program in the last 3 months,
  • Can walk without assistance,
  • Do not have serious and/or unstable heart disease, neuromuscular disease, orthopedic disease or mental illness that may impair their physical activities of daily living,
  • Willing to participate in the study will be included.

Exclusion criteria

  • Patients who have been hospitalized since the start of the study,
  • Those receiving continuous oxygen therapy,
  • Those who have cooperation problems,
  • Those who cannot adapt to exercise,
  • Those who have 2-3 or more acute attacks per year,
  • Those with a history of pulmonary hypertension, malignancy, pulmonary thromboembolism, obstructive sleep apnea, unstable angina or myocardial infarction,
  • Patients with a pulse rate over 120/minute will be excluded from the study.

Treatment and study plan

Balloon inflation exercise

Other

Balloon inflation exercise was applied in addition to the forward-leaning position.

Pursed-lip breathing exercise

Other

The pursed-lip breathing exercise was applied in addition to the forward-leaning position.

Control (Standard treatment)

Other

Standard practice is implemented in the institution where the study is conducted.

Primary outcomes

  1. blood pressure

    Time frame: 4 weeks later

  2. pulse

    Time frame: 4 weeks later

  3. respiratory rate

    Time frame: 4 weeks later

  4. saturation

    Time frame: 4 weeks later

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 4 weeks later

  2. Forced Expiratory Volume in One Second (FEV1)

    Time frame: 4 weeks later

  3. FEV1/FVC ratio

    Time frame: 4 weeks later

  4. Peak Expiratory Flow (PEF)

    Time frame: 4 weeks later

  5. Modified Borg Dyspnea Scale (MBS)

    Time frame: 4 weeks later

    MBS determines the severity of dyspnea at rest and during exertion. It consists of 10 items that define the severity of dyspnea according to its degree. A score of 0 indicates no dyspnea, and a score of 10 indicates very severe dyspnea.

  6. 6 Minute Walking Test (6MWT)

    Time frame: 4 weeks later

    The test evaluates functional exercise capacity by measuring the distance in meters that the patient will cover in 6 minutes by walking as fast as possible but without running in a 30-meter uninterrupted corridor.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Determination of the Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.