Effect of Breathing Exercises on Pain, Dyspnea, and Function in Terminal-Stage Cancer Patients

NCT07164352 | Completed DMC

• 1 other identifier: ATLAS-FTR-FNY-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of supervised breathing exercises on pain, dyspnea, and functionality in terminal-stage cancer patients receiving palliative care. Participants in the intervention group receive diaphragmatic and pursed-lip breathing exercises under the guidance of a physiotherapist, while the control group receives only an educational brochure. The study compares pre- and post-intervention outcomes between both groups.

Conditions

Palliative Patients; Terminal Malignant Tumors; Breathing Techniques

Keywords

Palliative Care; Terminal Stage Cancer; Breathing Exercises

Outcome Measures

Primary Outcomes (2)

• dyspnea

  Dyspnea severity will be assessed using the Edmonton Symptom Assessment System - revised (ESAS-r) dyspnea item. This is a numeric rating scale ranging from 0 to 10, where 0 indicates no shortness of breath and 10 indicates the worst possible shortness of breath. The outcome will evaluate changes in dyspnea severity following a structured breathing exercise intervention.

  From enrollment to the end of treatment at 1 weeks

• Functionality

  Functionality will be measured using the Edmonton Symptom Assessment System - revised (ESAS-r) physical well-being domain. The ESAS-r is a validated self-report instrument in which patients rate symptom severity on a scale from 0 to 10, with 0 indicating no impairment and 10 indicating the worst possible level of functional impairment. This outcome assesses changes in participants' ability to perform daily activities such as walking, dressing, and self-care.

  From enrollment to the end of treatment at 1 weeks

Study Arms (2)

Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist

EXPERIMENTAL

Participants in this arm receive supervised breathing exercises performed with a physiotherapist, focusing on diaphragmatic and pursed-lip breathing techniques.

Behavioral: Breathing Exercises

Brochure Education Only

ACTIVE COMPARATOR

Participants in this arm receive an informational brochure that explains breathing exercises, but no supervised exercise is provided.

Behavioral: Informational Brochure

Interventions

Breathing Exercises BEHAVIORAL

Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist.

Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist

Informational Brochure BEHAVIORAL

A brochure providing education about breathing exercises for cancer patients.

Brochure Education Only

Eligibility Criteria

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

You may qualify if:

• Patients receiving palliative care, who are part of this treatment process and considered eligible for the study.
• Patients diagnosed with Stage 4 cancer, included in the study due to their advanced cancer stage.
• Patients with oxygen saturation levels below 95% in room air, who are deemed appropriate for monitoring respiratory function due to this condition.
• Participants must be able to effectively communicate during the study period.
• Individuals who agree to participate in the study must provide written or verbal consent, which is a mandatory criterion for ethical compliance.

You may not qualify if:

• Patients who are unconscious and unable to participate in the study. Individuals under the age of 18.
• Patients dependent on a ventilator.
• Patients with serious health issues, such as uncontrolled hypertension and dyspnea.
• Patients with other significant health problems that prevent participation in the research program.
• Patients with medical conditions requiring drainage treatment.

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Eyupsultan State Hospital

Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Yaşar Gül BALTACI, Prof. Dr.

  İstanbul Atlas University, Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: September 10, 2025
• Study Start: August 4, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The intervention will be applied for 1 week per participant. Respiratory exercises will be conducted daily for 5 consecutive days. Baseline and post-intervention assessments will be performed at the beginning and end of the week, respectively.
• Access Criteria: De-identified individual participant data (IPD) may be made available upon reasonable request for academic or research purposes. Access requires submission of a detailed proposal and prior approval by the study investigator. Requests can be sent to yildiz.fatmanur@hotmail.com.

Locations

TU (1)