Breast CancerNCT07862426
Incentive Spirometry With and Without Transcutaneous Electric Diaphragmatic Stimulation in Post-mastectomy Patients
A study testing Transcutaneous Electrical Diaphragmatic Stimulation, Incentive Spirometer and Conventional Physiotherapy in people with Breast Cancer and Post-Mastectomy, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 48 years, women only
- Conditions the study is for
- Breast Cancer, Post-Mastectomy
- What is being tested?
- Transcutaneous Electrical Diaphragmatic Stimulation, Incentive Spirometer and Conventional Physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Sep 2026to 12 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Post-Mastectomy
- Being tested
- Transcutaneous Electrical Diaphragmatic Stimulation, Incentive Spirometer, Conventional Physiotherapy
- Keywords
- Mastectomy, Post-Mastectomy, Incentive Spirometer, Transcutaneous Electrical Diaphragmatic Stimulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Diaphragmatic StimulationDevice
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.
Incentive SpirometerDevice
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 PhysiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TEDS + Incentive Spirometer + Conventional Physiotherapy | Experimental | 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. Receives: Device: Transcutaneous Electrical Diaphragmatic Stimulation; Device: Incentive Spirometer; Behavioral: Conventional Physiotherapy |
| Incentive Spirometer + Conventional Physiotherapy | Active comparator | 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. Receives: Device: Incentive Spirometer; Behavioral: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start14 Sep 2026
- Primary completion13 Dec 2026 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to two parallel treatment groups. Group A will receive transcutaneous electrical diaphragmatic stimulation (TEDS), incentive spirometer training, and conventional physiotherapy. Group B will receive incentive spirometer training and conventional physiotherapy without TEDS. Treatment will be provided for 4 weeks, with assessments performed at baseline and at the fourth week.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seemab Khan, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862426
- Sponsor's protocol ID
- UOL/IREB/26/24/01/0004
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive Spirometry With and Without Transcutaneous Electric Diaphragmatic Stimulation in Post-mastectomy Patients
- ClinicalTrials.gov ID
- NCT07862426
- Acronym / sponsor ID
- UOL/IREB/26/24/01/0004
- Conditions
- Breast Cancer, Post-Mastectomy
- Keywords
- Mastectomy, Post-Mastectomy, Incentive Spirometer, Transcutaneous Electrical Diaphragmatic Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to two parallel treatment groups. Group A will receive transcutaneous electrical diaphragmatic stimulation (TEDS), incentive spirometer training, and conventional physiotherapy. Group B will receive incentive spirometer training and conventional physiotherapy without TEDS. Treatment will be provided for 4 weeks, with assessments performed at baseline and at the fourth week.
| Arm | Type | Receives |
|---|---|---|
| TEDS + Incentive Spirometer + Conventional Physiotherapy | Experimental | Device: Transcutaneous Electrical Diaphragmatic Stimulation, Device: Incentive Spirometer, Behavioral: Conventional PhysiotherapyParticipants 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. |
| Incentive Spirometer + Conventional Physiotherapy | Active comparator | Device: Incentive Spirometer, Behavioral: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 30 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Diaphragmatic StimulationTranscutaneous 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. | Device | TEDS + Incentive Spirometer + Conventional Physiotherapy |
| Incentive SpirometerParticipants 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. | Device | Incentive Spirometer + Conventional Physiotherapy, TEDS + Incentive Spirometer + Conventional Physiotherapy |
| Conventional PhysiotherapyConventional 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. | Behavioural | Incentive Spirometer + Conventional Physiotherapy, TEDS + Incentive Spirometer + Conventional Physiotherapy |
Primary outcome
Pulmonary Function (FEV/FVC) Assessed by Spirometry
Time frame: Baseline and 4 weeks
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.
3 secondary outcomes
Dyspnea Severity Assessed by Dyspnea Index
Time frame: Baseline and 4 weeks
Functional Mobility Assessed by Timed Up and Go Test
Time frame: Baseline and 4 weeks
Health-Related Quality of Life Assessed by SF-36
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Diaphragmatic Stimulation, Incentive Spirometer and Conventional Physiotherapy in people with Breast Cancer and Post-Mastectomy, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function (FEV/FVC) Assessed by Spirometry (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.