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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07229378
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Nov 2025
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Respiratory muscle strength training
    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.
  • Active Comparator: Guided Imagery Exercises
    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.

Primary Outcome Measure

Change in maximal inspiratory pressure [ Time Frame: Baseline, 2-4 weeks, and 2 weeks after surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Sandra P. Morgan, PhD
239-898-2036
Barbara K. Smith, PhD
352-294-5315
Sandra P. Morgan, PhD (PRINCIPAL_INVESTIGATOR)

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