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Active Not Recruiting NCT07862426

Incentive Spirometry With and Without Transcutaneous Electric Diaphragmatic Stimulation in Post-mastectomy Patients

Conditions: Breast Cancer, Post-Mastectomy

Sex: Female
Ages: 30 Years – 48 Years
Healthy volunteers: No
Phase: NA
Enrollment: 58
Sponsor: University of Lahore

Location: University of Lahore Teaching Hospital Lahore Punjab Province

Summary

This randomized clinical trial will compare the effects of incentive spirometer therapy with and without transcutaneous electrical diaphragmatic stimulation (TEDS) in females who have undergone mastectomy. The study will include females aged 30 to 48 years who have undergone unilateral simple or radical mastectomy following breast cancer and are at least 3 months after surgery. Participants will be randomly assigned to one of two treatment groups. Participants in one group will receive conventional physiotherapy along with transcutaneous electrical diaphragmatic stimulation and incentive spirometer training. Participants in the other group will receive conventional physiotherapy and incentive spirometer training without TEDS. Treatment will be provided over 4 weeks. The study will evaluate changes in breathing-related symptoms, functional capacity, lung function, and quality of life. These outcomes will be assessed using a dyspnea index, Timed Up and Go test, pulmonary function testing (spirometry), and the Short Form-36 health survey. Assessments will be performed at baseline and after 4 weeks of treatment. The study aims to determine whether adding transcutaneous electrical diaphragmatic stimulation to incentive spirometer therapy provides additional benefits for post-mastectomy females.

Eligibility Criteria

Inclusion Criteria: * Participants aged 30 to 48 years * Participants with unilateral mastectomy * Females who have undergone radical or simple mastectomy * Participants with a previous history of stage I to III breast cancer * Patients who are at least 3 months post-surgery * Participants who have been treated with chemotherapy or radiotherapy Exclusion Criteria: * Metastatic cancer to the lung, bone, or any other surrounding organ or tissue. * Uncontrollable hypertension greater than 140/90 mmHg * Unstable cardiovascular disease, such as arrhythmias or unstable angina * Any other acute or chronic respiratory disease, such as chronic obstructive pulmonary disease (COPD), asthma, or tuberculosis (TB) * Multiple sclerosis or Guillain-Barré syndrome * Visual impairment or hearing loss that affects the efficiency of exercise

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07862426). StuddyBuddy aggregates publicly available trial information.