Clinical trial NCT06928805: The Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters
Official title: Determination of the Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: Chronic Obstructive Pulmonary Disease
Breathing Techniques
Forward-Leaning Position
Physiological Parameters
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: blood pressure
timeFrame: 4 weeks later
measure: pulse
timeFrame: 4 weeks later
measure: respiratory rate
timeFrame: 4 weeks later
measure: saturation
timeFrame: 4 weeks later
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 4 weeks later
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: 4 weeks later
measure: FEV1/FVC ratio
timeFrame: 4 weeks later
measure: Peak Expiratory Flow (PEF)
timeFrame: 4 weeks later
measure: Modified Borg Dyspnea Scale (MBS)
timeFrame: 4 weeks later
measure: 6 Minute Walking Test (6MWT)
timeFrame: 4 weeks later
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences Turkey
state: Üsküdar
Study officials:
affiliation: University of Health Sciences Turkey, Hamidiye Faculty ofNursing
name: Semra Aciksoz, RN, Assistant Professor, PhD
role: PRINCIPAL_INVESTIGATOR
References: