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

University of Florida

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Respiratory muscle strength training; Behavioral: Guided Imagery Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07229378

IRB202501485

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Respiratory muscle strength training

Experimental group

Description:

Participants assigned to this arm will receive the equipment, education, and training to be able to perform respiratory muscle strength training for at least two weeks before breast cancer surgery.

Treatment:

Behavioral: Respiratory muscle strength training

Guided Imagery Exercises

Active Comparator group

Description:

Participants assigned to this group will receive education and training to be able to perform Guided Imagery, an exercise that uses relaxing, calming mental images, for at least two weeks prior to breast cancer surgery. This exercise does not provide respiratory strengthening and will thus be used as a comparator to respiratory muscle strength training.

Treatment:

Behavioral: Guided Imagery Exercises