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

NCT06928805 | Completed

• 1 other identifier: SaglikBilimleriU Semra Aciksoz
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Keywords

Chronic Obstructive Pulmonary Disease; Breathing Techniques; Forward-Leaning Position; Physiological Parameters

Outcome Measures

Primary Outcomes (4)

• blood pressure

  4 weeks later

• pulse

  4 weeks later

• respiratory rate

  4 weeks later

• saturation

  4 weeks later

Secondary Outcomes (6)

• Forced Vital Capacity (FVC)

  4 weeks later

• Forced Expiratory Volume in One Second (FEV1)

  4 weeks later

• FEV1/FVC ratio

  4 weeks later

• Peak Expiratory Flow (PEF)

  4 weeks later

• Modified Borg Dyspnea Scale (MBS)

  4 weeks later

Study Arms (3)

Pursed-lip breathing exercise

EXPERIMENTAL

Other: Pursed-lip breathing exercise

Balloon inflation exercise

EXPERIMENTAL

Other: Balloon inflation exercise

Standard treatment

EXPERIMENTAL

Other: Control (Standard treatment)

Interventions

Balloon inflation exercise OTHER

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

Balloon inflation exercise

Pursed-lip breathing exercise OTHER

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

Pursed-lip breathing exercise

Control (Standard treatment) OTHER

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

Standard treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Turkey

Istanbul, Üsküdar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Semra Aciksoz, RN, Assistant Professor, PhD

  University of Health Sciences Turkey, Hamidiye Faculty ofNursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 15, 2025
• Study Start: January 3, 2024
• Primary Completion: January 4, 2025
• Study Completion: February 2, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-03

Locations

TU (1)