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Идёт набор NCT07619209

The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Applied to Palliative Care Cancer Patients on Dyspnea, Fatigue, and Self-Care Behaviors

Без фазы С лечением Cancer Fatigue Palliative Care Progressive Muscle Relaxation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Progressive Muscle Relaxation, Deep Breathing Exercises.
Кому может быть актуально
Состояния в реестре: Cancer, Fatigue, Palliative Care, Progressive Muscle Relaxation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to evaluate the effects of Progressive Muscle Relaxation (PMR) exercises and deep breathing exercises on dyspnea, fatigue, and self-care behaviors among cancer patients receiving palliative care. Advanced-stage cancer patients frequently experience debilitating symptoms such as shortness of breath (dyspnea) and severe fatigue, which significantly impair their functional capacity and daily self-care activities. Participants in this study will be assigned to either a progressive muscle relaxation intervention group or a structured deep breathing exercise group. The study aims to determine whether these non-pharmacological relaxation techniques can effectively reduce the severity of dyspnea and fatigue, thereby improving the patients' overall self-care behaviors and physical comfort in a palliative care setting.

Подробное описание

Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial, and spiritual". Emphasizing the needs of patients and their families rather than the treatment of the disease itself, the primary goals of palliative care include reducing the disease burden and alleviating pain and other distressing symptoms. Palliative care is implemented for individuals with life-threatening chronic conditions such as cancer, cardiovascular diseases, HIV/AIDS, Alzheimer's and other dementias, liver cirrhosis, chronic obstructive pulmonary diseases (COPD), diabetes, kidney failure, multiple sclerosis, Parkinson's disease, rheumatoid arthritis, and drug-resistant . According to the European Association for Palliative Care (EAPC), approximately 4.4 million people (including 14,000 children) in the WHO European Region require palliative care each year. Patients diagnosed with cancer constitute the vast majority of those in need of palliative care, accounting for 34.01%. Indeed, the foundations of palliative care in our country began with interventions aimed at relieving pain and alleviating other symptoms of cancer patients by algology specialists and oncologists. Along with increased life expectancy and improving living conditions, an increase in cancer diseases is observed. According to global cancer statistics, with approximately 20 million new cancer cases and 9.7 million cancer deaths worldwide in 2022, it has become a major health problem both globally and for our country. Cancer patients require palliative care especially during the final stages of their lives/terminal period.

In palliative care, individuals experience numerous disease-related symptoms such as pain, fatigue, pruritus, cough, constipation, nausea, vomiting, dysphagia, dehydration, anorexia, delirium, and dyspnea. Advanced-stage cancer patients constitute a large proportion of patients receiving palliative care, and dyspnea is observed in approximately 10-70% of cancer patients. It is known that the prevalence of dyspnea rises up to 90% in patients with lung cancer. Dyspnea and shortness of breath are defined by ESMO as "a qualitatively distinct and subjective experience of breathing discomfort that varies in intensity". The experienced dyspnea causes anxiety, fear, fatigue, and a decrease in the quality of life in individuals. Fatigue is another frequently observed symptom in palliative care conditions. Fatigue is defined by patients using various concepts such as "weakness, exhaustion, tiredness, insomnia, and lack of strength." Cancer-related fatigue is a distressing symptom commonly seen in cancer patients that adversely affects activities of daily living and health-related quality of life. Fatigue occurs at a rate of 60-90% in cancer patients receiving palliative care.

In a study conducted by Uysal et al. (2015) on patients receiving palliative care, they determined that the most common symptoms observed were anxiety (92%), pain (90%), nausea (66%), constipation (61%), and shortness of breath (59%) (Uysal et al., 2015). In another study evaluating 142 cancer patients with palliative care needs, the presence of fatigue (87.3%), dyspnea (76.1%), and sleep problems (67.6%) were found to be the most prevalent, respectively.

Dyspnea burden and fatigue negatively affect the patient's self-care, their capacity to perform daily activities, functional capacity, and performance status. Self-care, as defined by Orem, is the form of care that an individual performs independently by displaying controlled, purposeful, and effective behaviors along with maintaining their health and well-being. Dyspnea and fatigue can affect self-care behaviors such as bathing, dressing, toileting, mobility, elimination, and nutrition by causing functional limitations in patients . The purpose of palliative care is to eliminate or alleviate these symptoms that may be observed in patients as early as possible. Thus, by performing a more effective symptom management, physical and psychological relief of patients will be achieved, thereby enhancing their self-care behaviors and quality of life .

Many pharmacological and non-pharmacological treatment methods are applied for the symptoms observed in palliative care patients. One of the non-pharmacological methods applied is breathing exercises. Breathing exercises for dyspnea management include pursed-lip breathing and diaphragmatic breathing. Pursed-lip breathing involves patients inhaling deeply through the nose and exhaling this breath over 4-6 seconds by pursing their lips. Pursed-lip breathing leads to an increase in tidal volume and arterial oxygen levels, a decrease in respiratory rate, and a decrease in arterial carbon dioxide levels. Diaphragmatic breathing involves the patient expanding their abdomen while inhaling, flattening the diaphragm muscle, and then exhaling by pursing their lips. During exhalation, the diaphragm is pushed upward by the abdominal muscles, and the utilization of diaphragm muscles is increased, thereby enhancing the ventilation level of the lungs. Studies have shown that performing pursed-lip and diaphragmatic breathing either alone or in combination are effective methods in relieving dyspnea-related distress in patients. Another non-pharmacological application for symptoms is relaxation exercises. Progressive Muscle Relaxation (PMR) covers the conscious contraction and relaxation of major muscle groups throughout the entire body. Each muscle or muscle group is tensed for 5-7 seconds and then relaxed for 20-30 seconds. One of the most important steps in the application of PMR is the correct breathing exercise. Relaxation exercises are applied simultaneously with deep breathing exercises, requiring the patient to breathe correctly, deeply, and effectively during the tensing-relaxing phase of the muscle groups. With the patient breathing effectively, correctly, and deeply throughout the exercise, the oxygen needed by using the whole of the lungs is taken into the body, and the relaxation of the patient is achieved through the relaxation of the muscles. Studies have revealed that relaxation techniques reduce heart rate, respiratory rate, and dyspnea, thereby being effective on fatigue by increasing functional performance. In studies conducted on cancer patients, it has also been determined that progressive muscle relaxation exercises are effective on weakness, loss of energy, fatigue, and dyspnea. Patients and their relatives in the palliative care process face many physical, psychosocial, and spiritual problems and difficulties. During this period, multiple symptoms observed in cancer patients negatively affect patients' physical and social functions, treatment course, and survival times. Therefore, preventing the occurrence of symptoms or controlling existing symptoms in palliative care patients is of great importance for patients and their relatives.

As a result of the literature review, no studies targeting dyspnea and fatigue symptoms observed in cancer patients receiving palliative care were found. The aim of our study is to examine the effects of progressive muscle relaxation and deep breathing exercises to be applied to cancer patients receiving palliative care on dyspnea, fatigue, and self-care behaviors.

This randomized controlled study aims to evaluate the effects of Progressive Muscle Relaxation (PMR) and Deep Breathing Exercises on dyspnea, fatigue, and self-care behaviors among cancer patients receiving palliative care. Patients meeting the inclusion criteria will be informed about the study's purpose, content, and method. Standard palliative care will be continued for all patients across all groups.

Study Arms and Interventions:

Following the randomization process, patients will be assigned to one of the following three groups for a duration of 6 weeks:

Intervention Group 1 (PMR Group): In the initial interview, patients will receive visual training regarding Progressive Muscle Relaxation (PMR) exercises. They will be provided with and instructed on how to use an MP3 player to practice these exercises at home. These patients will be asked to perform PMR exercises once a day for 6 weeks.

Intervention Group 2 (Deep Breathing Group): Patients in this group will receive detailed training on deep breathing exercises. They will be requested to perform these breathing exercises twice a day for 6 weeks.

Control Group: Patients assigned to this group will receive standard routine clinical care and follow-up without any additional experimental relaxation or breathing intervention.

For hospitalized patients in both intervention groups, the exercises will be directly administered and supervised by the researcher. Following patient discharge, the continuity and monitoring of the exercise protocols will be managed via phone-call follow-ups.

Data Collection and Timeline:

Data collection and instrument administration will be performed uniformly for all three groups at three specific timelines: Baseline (Pre-intervention), Week 3, and Week 6. The following measurement tools and scales will be utilized:

Patient Demographics and Characteristics Form

Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification

ECOG Performance Status Scale

Cancer Dyspnea Scale (CDS)

Hirai Cancer Fatigue Scale

KATZ Index of Independence in Activities of Daily Living (ADL)

Glasgow Coma Scale (GCS)

Вмешательства

  • Поведенческое Progressive Muscle Relaxation
    A structured relaxation training based on tension and release of major muscle groups. In the initial session, patients will receive visual and practical education on how to perform PMR. They will be provided with an MP3 player containing guided audio instructions to facilitate independent practice. Patients will be instructed to perform the PMR program once daily for 6 weeks. For hospitalized patients, the sessions will be guided directly by the researcher; discharged patients will be followed u
  • Поведенческое Deep Breathing Exercises
    A structured respiratory intervention consisting of controlled breathing techniques, specifically diaphragmatic (abdominal) breathing and pursed-lip breathing, aimed at managing dyspnea. Detailed practical training on these techniques will be provided to the patients in the first interview. Patients will be requested to perform these breathing exercises twice daily for 6 weeks. Hospitalized patients will perform them under the researcher's supervision, and discharged patients will be monitored v

Первичные конечные точки

  • Cancer Dyspnea Scale (CDS) [Срок оценки: Baseline (Pre-intervention), Week 3, and Week 6]
  • Hirai Cancer Fatigue Scale [Срок оценки: Baseline (Pre-intervention), Week3, Week 6]
  • Katz Index of Independence in Activities of Daily Living (ADL) [Срок оценки: Baseline (Pre-intervention), Week 3, and Week 6]

Критерии участия

Критерии включения

  • Being 18 years of age or older

Being literate (able to read and write)

Having no significant hearing or visual impairment that prevents communication or cooperation

Receiving treatment in the palliative care unit

Having a confirmed medical diagnosis of cancer

Having a Glasgow Coma Scale (GCS) score of 10 or higher

Being able to communicate via telephone and SMS for post-discharge follow-up

Having a Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification of Grade 3 or below

Having an ECOG Performance Status Scale score of 3 or below

Having a Hemoglobin (Hb) value of 8 gm/dL or higher

Volunteering to participate in the study and providing informed consent

Критерии исключения

  • Currently practicing or having recently practiced Progressive Muscle Relaxation (PMR) or deep breathing exercises actively

Having a primary respiratory system disease diagnosis (such as COPD, asthma, or pneumonia)

Having a medical diagnosis of dementia, agitation, or delirium

Receiving Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) support

Being on active antipsychotic or sedative medical treatment

Having a Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification of Grade 4 or higher

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 4 центра
  • Ankara Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital, Palliative Car — Ankara
  • Ankara Ataturk Sanatorium Training and Research Hospital,Palliative Care Unit — Ankara
  • Ankara Sincan Training and Research Hospital, Palliative Care Unit — Ankara
  • Gulhane Training and Research Hospital, Palliative Care Unit — Ankara

Публикации

  • Patel MS. Strategies for the Optimal Management of Dyspnea in Cancer Patients With Advanced Illness. Oncology (Williston Park). 2018 Dec 17;32(12):583-5, 590. PMID 30632127
  • Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10. PMID 34903440
  • Nese A, Samancioglu Baglama S. The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises on Dyspnea and Fatigue Symptoms of COPD Patients: A Randomized Controlled Study. Holist Nurs Pract. 2022 Jul-Aug 01;36(4):E18-E26. doi: 10.1097/HNP.0000000000000531. PMID 35708562
  • Hui D, Bohlke K, Bao T, Campbell TC, Coyne PJ, Currow DC, Gupta A, Leiser AL, Mori M, Nava S, Reinke LF, Roeland EJ, Seigel C, Walsh D, Campbell ML. Management of Dyspnea in Advanced Cancer: ASCO Guideline. J Clin Oncol. 2021 Apr 20;39(12):1389-1411. doi: 10.1200/JCO.20.03465. Epub 2021 Feb 22. PMID 33617290
  • Hui D, Maddocks M, Johnson MJ, Ekstrom M, Simon ST, Ogliari AC, Booth S, Ripamonti C; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Management of breathlessness in patients with cancer: ESMO Clinical Practice Guidelinesdagger. ESMO Open. 2020 Dec;5(6):e001038. doi: 10.1136/esmoopen-2020-001038. No abstract available. PMID 33303485
  • Yilmaz CK, Kapucu S. The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With COPD. Holist Nurs Pract. 2017 Nov/Dec;31(6):369-377. doi: 10.1097/HNP.0000000000000234. PMID 29028775
  • Kirca K, Kutluturkan S. The effect of progressive relaxation exercises on treatment-related symptoms and self-efficacy in patients with lung cancer receiving chemotherapy. Complement Ther Clin Pract. 2021 Nov;45:101488. doi: 10.1016/j.ctcp.2021.101488. Epub 2021 Oct 2. PMID 34619419
  • Demir Ö, Arslantaş H (2016). Müzik eşliğinde uygulanan progresif gevşeme egzersizinin anjiyografi ve perkütan transluminal koroner anjiyoplasti olacak hastaların yaşam bulgularına etkisi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi.; 19:1 84.

Идентификаторы

NCT: NCT07619209 · 2025-20/214

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗