An interventional study of Transcutaneous Electrical Diaphragmatic Stimulation and Incentive Spirometer in Breast Cancer and Post-Mastectomy, sponsored by University of Lahore. Active, not recruiting at 1 site in Pakistan. Open to female participants aged 30 Years to 48 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Lahore · Not applicable, Interventional, and Treatment
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.
Mastectomy is a surgical procedure used in the management of breast cancer. Following mastectomy, patients may experience changes in respiratory function, breathing patterns, functional capacity, and quality of life. This study will compare incentive spirometer therapy with and without transcutaneous electrical diaphragmatic stimulation (TEDS) in females following mastectomy.
This study is designed as a randomized clinical trial. Participants will be recruited from Pink Ribbon Hospital and randomly allocated to two treatment groups using sealed-envelope randomization. The study will include females aged 30 to 48 years who have undergone unilateral simple or radical mastectomy, have a history of stage I to III breast cancer, are at least 3 months post-surgery, and have received chemotherapy or radiotherapy.
Participants in Group A will receive conventional physiotherapy, transcutaneous electrical diaphragmatic stimulation, and incentive spirometer training. TEDS will be applied using surface electrodes placed over the lower rib cage. The intervention will be delivered using an electrical stimulation unit, with intensity adjusted to produce a visible or palpable diaphragmatic contraction without discomfort. Participants will also perform incentive spirometer exercises.
Participants in Group B will receive conventional physiotherapy and incentive spirometer training without TEDS.
Conventional physiotherapy will include diaphragmatic breathing, airway clearance exercises, circulatory exercises, thoracic expansion exercises, and postural awareness exercises. Treatment will be provided four times per week for 4 weeks.
The primary areas of assessment will include dyspnea, functional capacity, pulmonary function, and quality of life. Dyspnea will be assessed using a 5-point Likert-based dyspnea index. Functional capacity will be assessed using the Timed Up and Go test. Pulmonary function will be assessed using spirometry, including measurements of forced vital capacity and expiratory volume. Quality of life will be assessed using the Short Form-36 questionnaire.
Outcome assessments will be conducted at baseline and at the fourth week of the intervention. The study will evaluate whether adding TEDS to incentive spirometer therapy produces greater improvements in the measured outcomes compared with incentive spirometer therapy and conventional physiotherapy alone.
The study protocol specifies a randomized allocation procedure using sealed envelopes and a single-blinded outcome assessment, in which the assessor is blinded to group allocation.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 58 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Participants will receive transcutaneous electrical diaphragmatic stimulation (TEDS), incentive spirometer training, and conventional physiotherapy. TEDS will be applied using surface electrodes placed over the lower rib cage. Incentive spirometer training will also be provided. Conventional physiotherapy will include diaphragmatic breathing, airway clearance exercises, circulatory exercises, thoracic expansion exercises, and postural awareness exercises. Treatment will be provided four times per week for 4 weeks.
Device: Transcutaneous Electrical Diaphragmatic Stimulation · Device: Incentive Spirometer · Behavioral: Conventional Physiotherapy
Participants will receive incentive spirometer training and conventional physiotherapy without TEDS. Conventional physiotherapy will include diaphragmatic breathing, airway clearance exercises, circulatory exercises, thoracic expansion exercises, and postural awareness exercises. Treatment will be provided four times per week for 4 weeks.
Device: Incentive Spirometer · Behavioral: Conventional Physiotherapy
Transcutaneous electrical diaphragmatic stimulation (TEDS) will be applied using surface electrodes placed over the lower rib cage. Electrical stimulation will be delivered using a portable electrical stimulation unit, with intensity adjusted to produce a visible or palpable diaphragmatic contraction without discomfort. TEDS will be provided to participants in the experimental group in addition to incentive spirometer training and conventional physiotherapy.
Participants will perform incentive spirometer breathing exercises in a half-lying position at approximately 45 degrees. The protocol describes repeated deep breaths with an inspiratory hold. Incentive spirometer training will be provided to both treatment groups during the 4-week intervention period, in addition to conventional physiotherapy.
Conventional physiotherapy will be provided to both groups and will include diaphragmatic breathing exercises, airway clearance exercises, circulatory exercises, thoracic expansion exercises, and postural awareness exercises. The conventional therapy component is described as a 20-minute session and will be provided four times per week for 4 weeks.
Pulmonary Function (FEV/FVC) Assessed by Spirometry
Pulmonary function will be assessed using spirometry, including forced vital capacity (FVC) and expiratory volume. The FEV/FVC ratio will be used to evaluate pulmonary function and changes following the intervention.
Time frame: Baseline and 4 weeks
Dyspnea Severity Assessed by Dyspnea Index
Dyspnea severity will be assessed using a 5-point Likert-based Dyspnea Index. Scores range from 0 to 40, with higher scores indicating greater severity of breathing difficulty.
Time frame: Baseline and 4 weeks
Functional Mobility Assessed by Timed Up and Go Test
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The participant will rise from a standard chair, walk approximately 3 meters, turn around, return to the chair, and sit down. Performance will be recorded in seconds.
Time frame: Baseline and 4 weeks
Health-Related Quality of Life Assessed by SF-36
Health-related quality of life will be assessed using the Short Form-36 Health Survey Questionnaire (SF-36), which evaluates overall health status and different aspects of physical and psychosocial well-being.
Time frame: Baseline and 4 weeks
Plan to share: No — Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
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