Palliative PatientsNCT07164352
Effect of Breathing Exercises on Pain, Dyspnea, and Function in Terminal-Stage Cancer Patients
A study testing Breathing Exercises and Informational Brochure in people with Palliative Patients and Terminal Malignant Tumors, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Patients, Terminal Malignant Tumors, Breathing Techniques
- What is being tested?
- Breathing Exercises and Informational Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Breathing Exercises on Pain, Dyspnea, and Functionality in Terminal-Stage Cancer Patients Receiving Palliative Care - Master's Thesis, İstanbul Atlas University, Graduate School, Dept. of Physical Medicine and Rehabilitation
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.
Read the detailed description
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.
- Being tested
- Breathing Exercises, Informational Brochure
- Keywords
- Palliative Care, Terminal Stage Cancer, Breathing Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExercisesBehavioural
Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist.
Informational BrochureBehavioural
A brochure providing education about breathing exercises for cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Informational Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start4 Aug 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Yildiz, Atlas University
- Investigators
- Yaşar Gül BALTACI, Prof. Dr., Study director, İstanbul Atlas University, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164352
- Sponsor's protocol ID
- ATLAS-FTR-FNY-01
- Status last verified
- Sep 2025
- First submitted
- 23 May 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercises on Pain, Dyspnea, and Functionality in Terminal-Stage Cancer Patients Receiving Palliative Care - Master's Thesis, İstanbul Atlas University, Graduate School, Dept. of Physical Medicine and Rehabilitation
- ClinicalTrials.gov ID
- NCT07164352
- Acronym / sponsor ID
- ATLAS-FTR-FNY-01
- Keywords
- Palliative Care, Terminal Stage Cancer, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist | Experimental | Behavioral: Breathing ExercisesParticipants in this arm receive supervised breathing exercises performed with a physiotherapist, focusing on diaphragmatic and pursed-lip breathing techniques. |
| Brochure Education Only | Active comparator | Behavioral: Informational BrochureParticipants in this arm receive an informational brochure that explains breathing exercises, but no supervised exercise is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing ExercisesDiaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist. | Behavioural | Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist |
| Informational BrochureA brochure providing education about breathing exercises for cancer patients. | Behavioural | Brochure Education Only |
Primary outcome
dyspnea
Time frame: From enrollment to the end of treatment at 1 weeks
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.
Functionality
Time frame: From enrollment to the end of treatment at 1 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaşar Gül BALTACI, Prof. Dr. study director
İstanbul Atlas University, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises and Informational Brochure in people with Palliative Patients and Terminal Malignant Tumors, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dyspnea (time frame: From enrollment to the end of treatment at 1 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.