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
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- 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.
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 trainingParticipants 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 ExercisesParticipants 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
- Sandra P. Morgan, PhD1-239-898-2036
- Barbara K. Smith, PhD352-294-5315
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | Sandra P. Morgan, PhD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Gainesville, FL
Related Studies
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast CancerPHASE2 · Recruiting · QuantumLeap Healthcare Collaborative · Birmingham, Alabama
- Integrated Cancer Repository for Cancer ResearchRecruiting · University of Nebraska · Greenwood Village, Colorado
- Women Informed to Screen Depending on Measures of Risk (Wisdom Study)Recruiting · University of California, San Francisco · Birmingham, Alabama
- MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression ProfilesRecruiting · Agendia · Birmingham, Alabama