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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.
This randomized controlled trial aims to investigate the effects of diaphragmatic and pursed-lip breathing exercises on pain, dyspnea, and functional status in terminal-stage cancer patients receiving palliative care. Participants are divided into two groups: the intervention group receives supervised breathing exercises by a physiotherapist, while the control group is given an informational brochure without any physical guidance.
The primary objective is to determine whether supervised breathing exercises provide significant improvements in symptom control and functionality compared to usual care. Assessments are made before and after the intervention using validated tools including the Edmonton Symptom Assessment System (ESAS-r), the Cancer Dyspnea Scale (CDS), and the Visual Analog Scale (VAS) for pain.
The study aims to contribute to the clinical evidence supporting non-pharmacological interventions in palliative care and to offer practical approaches for improving quality of life in terminally ill cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Brochure Education Only | Active Comparator | Participants in this arm receive an informational brochure that explains breathing exercises, but no supervised exercise is provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing Exercises | Behavioral | Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaşar Gül BALTACI, Prof. Dr. | İstanbul Atlas University, Department of Physical Medicine and Rehabilitation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eyupsultan State Hospital | Istanbul | 34500 | Turkey (Türkiye) |
This clinical trial evaluates the effects of structured respiratory exercises on pain, dyspnea, and physical functionality in terminal-stage cancer patients under palliative care. It is a single-arm interventional study with pre- and post-intervention assessments. Participants perform pursed-lip and diaphragmatic breathing exercises under physiotherapist supervision for one week. The primary outcomes are changes in pain and dyspnea, measured using ESAS-r and CDS. Secondary outcomes include functional status assessed via standardized tools. Data are collected at baseline and after the intervention. The study follows the Declaration of Helsinki and has received institutional ethical approval. Results aim to support the use of non-pharmacological methods in enhancing the quality of life for patients in end-of-life care.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2025 | Sep 7, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2025 | Sep 7, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| Informational Brochure | Behavioral | A brochure providing education about breathing exercises for cancer patients. |
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| D026741 |
| Physical Therapy Modalities |