Respiratory Muscle Strength Training to Prevent Respiratory Muscle Weakness in Adults Newly Diagnosed With Breast Cancer

Официальное название

Respiratory Muscle Strength Training to Prevent Dyspnea in the Newly Diagnosed Breast Cancer Patient Prior to Surgery"

Обзор

The goal of this clinical trial is to learn if respiratory muscle strength training can prevent respiratory muscle weakness in adults who are newly diagnosed with breast cancer and are planning to have surgery. The main question it aims to answer is: * Does respiratory muscle strength training in adults preparing for breast cancer surgery reduce the weakness that often occurs with surgery. Researchers will compare Guided Imagery exercises to respiratory muscle strength training to see which is more helpful. Participants will: * Carry out respiratory muscle strength training or Guided Imagery exercises for at least 2 weeks at home. * Meet with the researcher at home to complete breathing measurements before starting the exercises, after completing the exercises, and again after surgery. * Keep a diary of the exercises that have been completed.

Подробное описание

Introduction and Challenge: The therapies required to treat breast cancer can cause side effects such as muscle weakness and breathing problems. Surgery, chemotherapy, radiation, and some necessary breast cancer drug treatments can all contribute to a weakness in breathing function. Additionally, respiratory muscle strength and flexibility decrease in older adults as a part of the natural aging process. Unfortunately, the combination of breast cancer treatments with aging can contribute to an increase in breathing problems. Weakened breathing muscles and less chest wall flexibility leads to a decreased ability to complete normal daily activities, potentially causing increased anxiety and depression, and an overall decrease in quality of life.

Respiratory muscle strength training is an exercise that has been found to specifically focus on building the muscle strength and function of breathing. Respiratory muscle strength training is an exercise that is performed while sitting in a chair at home, for 15 minutes each day. The participant inhales into a handheld device that provides resistance during inhalation. Respiratory muscle strength training has been successfully used in other people with chronic illnesses, lung cancer, cardiac surgery, head and neck cancer, and patients preparing for surgery. Recently, it was trialed in a group of breast cancer patients after surgery, combined with aerobic exercises, with reports that the group that received respiratory muscle strength training had better outcomes. However, respiratory strength training has not yet been used on its own, as a preventative exercise before breast cancer surgery.

Methods and Action Plan: In this proposed study, the investigators plan to compare a group of newly diagnosed breast cancer patients who carry out daily respiratory muscle strength training exercises, to a group of newly diagnosed breast cancer patients who perform daily Guided Imagery. Guided Imagery has been found to improve anxiety and depression through the use of relaxing mental images designed to activate the body-mind connection. The researcher will carry out the study visits and teaching in the participant's home. The study equipment is portable, and the daily exercises can be done at home. This will help reduce the newly diagnosed breast cancer patient's burden of participating in this study. The investigator will measure respiratory strength, breathing function, diaphragm muscle thickness, chest mobility, anxiety and depression, and quality of life before and after the respiratory muscle strength training and the Guided Imagery protocols, and compare the results of the two groups. Each participant will be taught how to perform the assigned exercises, filling out exercise diaries, and talking by phone with the researcher each week for progress updates about the exercises, as well as how difficult they feel the exercises are.

Results and Main Findings: The investigators hypothesize that the individuals who perform the respiratory muscle strength exercises will find the respiratory strengthening protocol acceptable, and will have stronger breathing muscles, better breathing function, more chest mobility, thicker diaphragms, less anxiety and depression, and increased quality of life scores than those who performed deep breathing exercises, and that the Guided Imagery group may experience less anxiety and depression. The investigators anticipate that older breast cancer patients will benefit more than younger breast cancer patients after performing respiratory strength training.

Conclusion and Impact: This study will provide the opportunity to test whether respiratory strength training is acceptable to newly diagnosed breast cancer patients, and whether it protects and supports the breast cancer patient from respiratory weakness prior to surgery. These results will also allow the investigators to assess the impact of respiratory strength training on the older breast cancer patient. If successful, the next steps will include developing a larger clinical trial to test a diverse population to ensure the protocol is successful, before integrating this exercise into standard clinical practice for breast cancer patients.

Вмешательства

• Поведенческое Respiratory muscle strength training
  At the baseline visit, participants will receive an inspiratory muscle strength trainer pre-set for 40% of their measured maximal inspiratory pressure, and respiratory exercise education using a teach back method in the form of demonstration, as well as written instructions. The respiratory strength exercises are to be performed five days/week for at least two weeks, for a total of 45 breaths each day. Inspiratory respiratory muscle strength training for at least two weeks has been shown to redu
• Поведенческое Guided Imagery Exercises
  Guided Imagery, a relaxation technique that utilizes visualization to develop relaxing, peaceful images to help improve emotional health by reducing anxiety, and stress. At the baseline visit, participants will receive training to perform Guided Imagery techniques using a teach back method in the form of demonstration and return demonstration for the exercise technique, as well as written instructions. Exercise diaries and weekly follow-up phone calls will be used to monitor and document exercis

Первичные конечные точки

• Change in maximal inspiratory pressure [Срок оценки: Baseline, 2-4 weeks, and 2 weeks after surgery.]

Вторичные конечные точки (6)

• Change in Diaphragmatic thickness [Срок оценки: Baseline, 2-4 weeks, and 2 weeks after surgery]
• Change in Thoracic expansion [Срок оценки: Baseline, 2-4 weeks, and 2 weeks after surgery.]
• Change in Dyspnea [Срок оценки: Baseline, 2-4 weeks, and 2 weeks after surgery]
• Change in Anxiety and Depression [Срок оценки: Baseline, 2-4 weeks, and 2 weeks after surgery.]
• European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) [Срок оценки: Baseline, 2-4 weeks, 2 weeks after surgery.]
• Six Minute Walk Test Distance [Срок оценки: Baseline, 2-4 weeks after the intervention, and 2 weeks after surgery.]

Критерии участия

Критерии включения

• Community-dwelling adults (>18 years)
• Recently diagnosed with breast cancer
• Scheduled for breast cancer surgery
• English speaking, and can follow the protocol

Критерии исключения

• Individuals who have already completed respiratory muscle strength training exercises
• Pregnancy,
• Recent pneumothorax
• Ruptured eardrum
• Uncontrolled hypertension, or uncontrolled reflux.
• Individuals who cannot complete at least ten exercise sessions

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

Профилактика

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Публикации

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• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002. PMID 28186222
• Lumb AB. Pre-operative respiratory optimisation: an expert review. Anaesthesia. 2019 Jan;74 Suppl 1:43-48. doi: 10.1111/anae.14508. PMID 30604419
• Lovelace DL, McDaniel LR, Golden D. Long-Term Effects of Breast Cancer Surgery, Treatment, and Survivor Care. J Midwifery Womens Health. 2019 Nov;64(6):713-724. doi: 10.1111/jmwh.13012. Epub 2019 Jul 19. PMID 31322834
• Ibrahim AA, Gabr Ali AMM, Fadulelmulla IA, Ragab MMM, Aldemery AA, Mohamed AR, Dewir IM, Hakami HA, Hussein HM. Using Inspiratory Muscle Training to Improve Respiratory Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery. J Multidiscip Healthc. 2024 May 1;17:1931-1941. doi: 10.2147/JMDH.S463961. eCollection 2024. PMID 38706507

Идентификаторы

NCT: NCT07229378 · IRB202501485

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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