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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Florida

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Respiratory muscle strength training

    Behavioral

    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 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

    Behavioral

    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 exercises.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Respiratory muscle strength trainingExperimental treatment 1 intervention
Group B: Guided Imagery ExercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 2-4 weeks, and 2 weeks after surgery.

Secondary outcomes

1

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.

Time frame
Baseline, 2-4 weeks, and 2 weeks after surgery
2

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.

Time frame
Baseline, 2-4 weeks, and 2 weeks after surgery.
3

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.

Time frame
Baseline, 2-4 weeks, and 2 weeks after surgery
4

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.

Time frame
Baseline, 2-4 weeks, and 2 weeks after surgery.

Other outcomes

1

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.

Time frame
Two weeks after surgery.
2

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.

Time frame
Through study completion, an average of one year.
3

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.

Time frame
Through study completion, an average of one year.
4

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

Time frame
Through study completion, an average of one year.

Sponsors and contacts

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