About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community-dwelling adults (>18 years)
Recently diagnosed with breast cancer
Scheduled for breast cancer surgery
English speaking, and can follow the protocol
Disqualifiers
Individuals who have already completed respiratory muscle strength training exercises
Pregnancy,
Recent pneumothorax
Ruptured eardrum
Trial design
Parallel
Treatments tested in this trial
Respiratory muscle strength training
BehavioralAt 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 reduce respiratory complications because of surgery in other populations (Lumb, 2019). Respiratory resistance will be increased by 10% each week following an assessment using the modified Borg scale, if participants rate the perceived level of exertion ≤ 5 (Mahler \& Horowitz, 1994). Exercise diaries and weekly follow-up phone calls will be used to monitor and document exercises.
Guided Imagery Exercises
BehavioralGuided 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 exercises.
Treatment groups
Trial outcomes
Primary outcomes
Change in maximal inspiratory pressure
Maximal inspiratory pressure (MIP) will be assessed as a measure of respiratory strength, using a respiratory pressure meter, a pocket-sized device that allows measures to be obtained with an accuracy of +/- 3%. Changes in MIP will be assessed at three timepoints.
Secondary outcomes
Change in Diaphragmatic thickness
Diaphragm thickness will be measured with a handheld ultrasound device to record diaphragm thickness and at both end-inspiration and end expiration. A change in diaphragmatic thickness will be assessed at each of the three timepoints.
Change in Thoracic expansion
Thoracic expansion will be measured with a Gulick tape measure positioned around the participant's chest at the 4th intercostal space and will be used to record the difference between maximal inspiration and maximal expiration. The measures will be assessed at each of the three timepoints to assess for change over time.
Change in Dyspnea
The Modified medical research council scale (MMRC) will be used to assess for a change in participants' dyspnea over the three timepoints. The MMRC scale includes a range of 0-4, with 4 being the most severe dyspnea.
Change in Anxiety and Depression
The Hospital Anxiety and Depression scale (HADS) is a two subscale, 14-question scale with Likert-style responses focused on feelings of anxiety and depression. A higher score represents increasing severity of symptoms of anxiety and/or depression. A change in scores will be assessed at each of the three timepoints.
Other outcomes
Feasibility and acceptability
Scores on a 6-question, Likert-style feasibility and acceptability questionnaire will be calculated, with higher scores indicating a higher participant perception of the feasibility and acceptability of the study.
Compliance with exercise diaries
Participant compliance with the exercise diaries will be assessed at the completion of the study and documented as a percentage. Higher scores will indicate stronger compliance.
Retention Rates
Retention rates will be reported at the completion of the study in the form of a percentage. Higher scores indicate a higher rate of participant retention.
Compliance with weekly phone calls
Compliance with weekly phone calls will be assessed at the end of the participant's study visits and reported as a percentage. Higher percentages indicate stronger compliance with phone calls
Sponsors and contacts
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