Breast NeoplasmsRESPIRA-BCNCT07884968
Multimodal Respiratory Physiotherapy in Women Receiving Radiotherapy for Breast Cancer (RESPIRA-BC)
A study testing Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training, Individualised Exercise Programme (Aerobic and Resistance Training) and Patient Education Programme in people with Breast Neoplasms, run by University of Alcala at 1 site in Spain.
Trial summary
Radiotherapy is an important treatment for breast cancer, but it may affect lung function and physical ability, making everyday activities more difficult. Breathing exercises may help women recover after treatment, although more research is needed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training, Individualised Exercise Programme (Aerobic and Resistance Training) and Patient Education Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with unilateral breast cancer.
- Scheduled to undergo breast cancer surgery.
- Adjuvant radiotherapy planned as part of oncological treatment.
Who cannot join
- Bilateral breast cancer.
- Metastatic breast cancer.
- Severe cardiorespiratory conditions limiting exercise participation.
- Severe neurological conditions limiting exercise participation.
- Severe musculoskeletal conditions limiting exercise participation.
- Cognitive impairment affecting comprehension of the intervention.
- Any other condition preventing completion of the study assessments or intervention
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Nursing and Physiotherapy, University of Alcalá
Alcalá de Henares, Madrid, 28805
About this study
Official title: Multimodal Respiratory Physiotherapy Including Incentive Spirometry and Positive Expiratory Pressure for Women Treated for Breast Cancer With Radiotherapy: a Pilot Randomised Controlled Trial.
Radiotherapy is an important treatment for breast cancer, but it may affect lung function and physical ability, making everyday activities more difficult. Breathing exercises may help women recover after treatment, although more research is needed.
The main aim of this pilot study was to assess whether a four-week respiratory physiotherapy programme was practical and safe for women treated for breast cancer with radiotherapy. The study also explored its potential benefits for lung function, physical ability, physical activity, fatigue and quality of life.
Participants were randomly assigned to two groups. Both groups received patient education and an individualised exercise programme. In addition, one group performed breathing exercises at home using two devices: one to encourage deep breathing (incentive spirometry) and another to provide resistance when breathing out (positive expiratory pressure). The study compared both groups to explore whether adding these breathing exercises provided additional benefits.
Read the detailed description
This single-centre, two-arm, parallel-group, assessor-blinded pilot randomised controlled trial was conducted at the Hospital Universitario Príncipe de Asturias in Alcalá de Henares, Spain. Physiotherapy interventions were delivered at the University of Alcalá.
Participants were allocated using a computer-generated randomisation sequence, with allocation concealment maintained through sequentially numbered, opaque, sealed envelopes. Outcome assessments were conducted by researchers who remained unaware of group allocation.
The physiotherapy intervention began three months after completion of radiotherapy and lasted four weeks. Participants attended four individual, face-to-face physiotherapy sessions, scheduled once weekly. The programme included patient education and individually prescribed aerobic and resistance exercise, performed independently at home or in community settings. Additional respiratory training was performed using incentive spirometry and positive expiratory pressure devices, following individual instruction and supervision.
Exercise and respiratory training were prescribed according to each participant's physical condition and tolerance. Physical activity was monitored using wrist-worn activity trackers, while adherence to the intervention was reviewed during the weekly sessions.
Assessments were conducted at five time points: before breast cancer surgery, after surgery, three months after radiotherapy (pre-intervention), four months after radiotherapy (post-intervention), and six months after radiotherapy (follow-up).
Feasibility was assessed through recruitment, retention, attendance, and adherence to the prescribed activities. Safety was evaluated by recording adverse events during the intervention period. Clinical outcomes were analysed exploratorily to estimate changes over time and between-group differences, accounting for age, body mass index, and the number of radiotherapy sessions.
- Conditions
- Breast Neoplasms
- Being tested
- Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training, Individualised Exercise Programme (Aerobic and Resistance Training), Patient Education Programme
- Keywords
- breast cancer, radiotherapy, respiratory physiotherapy, incentive spirometry, positive expiratory pressure, exercise therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) TrainingOther
Participants completed a four-week home-based respiratory training programme combining incentive spirometry (IS) and positive expiratory pressure (PEP) using Voldyne 5000 and Threshold PEP devices, respectively.
Training was performed for at least 30 minutes per day, five days per week, comprising 2-4 sets of 8-15 deep inspirations with a 3-5-second breath hold, followed by 8-15 breaths against expiratory resistance, with 2-3 minutes of rest between sets.
Participants received initial supervised instruction, and training parameters were reviewed and individually adjusted during weekly physiotherapy sessions.
Individualised Exercise Programme (Aerobic and Resistance Training)Other
Participants received a four-week individually prescribed exercise programme combining aerobic and resistance training.
Aerobic exercise consisted of walking or cycling for at least 30 minutes per day, five days per week, at moderate-to-vigorous intensity (70-85% of age-predicted maximum heart rate).
Resistance training targeted major muscle groups, comprising 2-4 sets of 8-12 repetitions, twice weekly, initially at 40-60% of one-repetition maximum.
Exercises were performed independently at home or in community settings, with individual prescriptions reviewed during weekly physiotherapy sessions.
Patient Education ProgrammeOther
Participants received a four-week patient education programme addressing respiratory anatomy and physiology, potential respiratory consequences of breast cancer treatment, and the benefits of physical exercise for cardiorespiratory function and functional capacity.
Education was delivered during weekly face-to-face physiotherapy sessions and supported by printed educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Respiratory Physiotherapy (IS + PEP) | Experimental | Participants received a four-week multimodal respiratory physiotherapy programme comprising patient education, individually prescribed aerobic and resistance exercise, and home-based respiratory training using incentive spirometry (IS) and positive expiratory pressure (PEP) devices. Receives: Other: Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training; Other: Individualised Exercise Programme (Aerobic and Resistance Training); Other: Patient Education Programme |
| Exercise and Patient Education | Active comparator | Participants received a four-week programme comprising patient education and individually prescribed aerobic and resistance exercise. Receives: Other: Individualised Exercise Programme (Aerobic and Resistance Training); Other: Patient Education Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible women who agreed to participate and were enrolled and randomised in the study, expressed as a percentage of all eligible women invited to participate.
Measured: During the recruitment period
Screening-to-Randomisation Yield
Description
Proportion of women randomised into the study relative to the total number of women assessed for eligibility, expressed as a percentage.
Measured: During the recruitment period
Retention Rate
Proportion of randomised participants who completed all study assessments, expressed as a percentage of the total number of randomised participants.
Measured: From randomisation to the final follow-up assessment (six months after radiotherapy).
Attendance at Face-to-Face Physiotherapy Sessions
Proportion of individual face-to-face physiotherapy sessions attended relative to the total number of scheduled sessions, expressed as a percentage.
Measured: Throughout the four-week intervention period.
Adherence to the Home-Based Exercise Programme
Proportion of intervention weeks during which participants achieved the prescribed exercise target of at least 30 minutes per day, five days per week, expressed as a percentage.
Measured: Throughout the four-week intervention period.
Adherence to Respiratory Training
Proportion of intervention weeks during which participants in the experimental group achieved the prescribed respiratory training target of at least 30 minutes per day, five days per week, expressed as a percentage.
Measured: Throughout the four-week intervention period.
Adverse Events Related to the Intervention (Safety)
Number and proportion of participants experiencing adverse events during the intervention period. Adverse events were recorded and classified according to their type, seriousness, and potential relationship to the study intervention.
Measured: Throughout the four-week intervention period
Secondary outcomes (10)
Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in one second (FEV1) was assessed using spirometry and expressed as a percentage of the predicted value (% predicted).
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Forced Vital Capacity (FVC)
Forced vital capacity (FVC) was assessed using spirometry and expressed as a percentage of the predicted value (% predicted).
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Diffusing Capacity of the Lung for Carbon Monoxide (DLCOadj)
Lung diffusing capacity for carbon monoxide (DLCO), adjusted for haemoglobin concentration, was assessed using the single-breath diffusion test and expressed as a percentage of the predicted value (% predicted).
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Alveolar Volume (VA)
Alveolar volume (VA) was assessed during the single-breath lung diffusion test and expressed as a percentage of the predicted value (% predicted).
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Carbon Monoxide Transfer Coefficient (KCO)
Carbon monoxide transfer coefficient (KCO) was assessed using the single-breath lung diffusion test and expressed as a percentage of the predicted value (% predicted).
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
One-Minute Sit-to-Stand Test (1minSTS)
Functional capacity was assessed using the one-minute sit-to-stand test (1minSTS). The total number of complete sit-to-stand repetitions performed within one minute was recorded.
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Six-Minute Walking Distance (6MWD)
Functional capacity was assessed using the six-minute walk test (6MWT). The total distance walked in six minutes was recorded in metres.
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Self-reported physical activity and sedentary time
It was were assessed using the International Physical Activity Questionnaire-short form-IPAQ-sf and expressed as metabolic equivalent minutes per week (MET-min/week).
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Fatigue
It was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-FS). The scale consists of 13 items, with a total score ranging from 0 to 52. Higher scores indicate lower levels of fatigue and better outcomes.
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Health-Related Quality of Life
It was assessed using the Functional Assessment of Cancer Therapy-Breast questionnaire. (FACT-B). The questionnaire consists of 37 items, with a total score ranging from 0 to 148. Higher scores indicate better health-related quality of life.
Measured: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Mar 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Prieto Gómez, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884968
- Sponsor's protocol ID
- PIPS-08-2021
- Acronym
- RESPIRA-BC
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality. Study findings will be reported in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Respiratory Physiotherapy Including Incentive Spirometry and Positive Expiratory Pressure for Women Treated for Breast Cancer With Radiotherapy: a Pilot Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07884968
- Acronym / sponsor ID
- RESPIRA-BC / PIPS-08-2021
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, radiotherapy, respiratory physiotherapy, incentive spirometry, positive expiratory pressure, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 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.
Radiotherapy is an important treatment for breast cancer, but it may affect lung function and physical ability, making everyday activities more difficult. Breathing exercises may help women recover after treatment, although more research is needed.
The main aim of this pilot study was to assess whether a four-week respiratory physiotherapy programme was practical and safe for women treated for breast cancer with radiotherapy. The study also explored its potential benefits for lung function, physical ability, physical activity, fatigue and quality of life.
Participants were randomly assigned to two groups. Both groups received patient education and an individualised exercise programme. In addition, one group performed breathing exercises at home using two devices: one to encourage deep breathing (incentive spirometry) and another to provide resistance when breathing out (positive expiratory pressure). The study compared both groups to explore whether adding these breathing exercises provided additional benefits.
Detailed description
This single-centre, two-arm, parallel-group, assessor-blinded pilot randomised controlled trial was conducted at the Hospital Universitario Príncipe de Asturias in Alcalá de Henares, Spain. Physiotherapy interventions were delivered at the University of Alcalá.
Participants were allocated using a computer-generated randomisation sequence, with allocation concealment maintained through sequentially numbered, opaque, sealed envelopes. Outcome assessments were conducted by researchers who remained unaware of group allocation.
The physiotherapy intervention began three months after completion of radiotherapy and lasted four weeks. Participants attended four individual, face-to-face physiotherapy sessions, scheduled once weekly. The programme included patient education and individually prescribed aerobic and resistance exercise, performed independently at home or in community settings. Additional respiratory training was performed using incentive spirometry and positive expiratory pressure devices, following individual instruction and supervision.
Exercise and respiratory training were prescribed according to each participant's physical condition and tolerance. Physical activity was monitored using wrist-worn activity trackers, while adherence to the intervention was reviewed during the weekly sessions.
Assessments were conducted at five time points: before breast cancer surgery, after surgery, three months after radiotherapy (pre-intervention), four months after radiotherapy (post-intervention), and six months after radiotherapy (follow-up).
Feasibility was assessed through recruitment, retention, attendance, and adherence to the prescribed activities. Safety was evaluated by recording adverse events during the intervention period. Clinical outcomes were analysed exploratorily to estimate changes over time and between-group differences, accounting for age, body mass index, and the number of radiotherapy sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Respiratory Physiotherapy (IS + PEP) | Experimental | Other: Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training, Other: Individualised Exercise Programme (Aerobic and Resistance Training), Other: Patient Education ProgrammeParticipants received a four-week multimodal respiratory physiotherapy programme comprising patient education, individually prescribed aerobic and resistance exercise, and home-based respiratory training using incentive spirometry (IS) and positive expiratory pressure (PEP) devices. |
| Exercise and Patient Education | Active comparator | Other: Individualised Exercise Programme (Aerobic and Resistance Training), Other: Patient Education ProgrammeParticipants received a four-week programme comprising patient education and individually prescribed aerobic and resistance exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with unilateral breast cancer.
- Scheduled to undergo breast cancer surgery.
- Adjuvant radiotherapy planned as part of oncological treatment.
Key exclusion criteria (7 listed)
- Bilateral breast cancer.
- Metastatic breast cancer.
- Severe cardiorespiratory conditions limiting exercise participation.
- Severe neurological conditions limiting exercise participation.
- Severe musculoskeletal conditions limiting exercise participation.
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 |
|---|---|---|
| Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) TrainingParticipants completed a four-week home-based respiratory training programme combining incentive spirometry (IS) and positive expiratory pressure (PEP) using Voldyne 5000 and Threshold PEP devices, respectively. Training was performed for at least 30 minutes per day, five days per week, comprising 2-4 sets of 8-15 deep inspirations with a 3-5-second breath hold, followed by 8-15 breaths against expiratory resistance, with 2-3 minutes of rest between sets. Participants received initial supervised instruction, and training parameters were reviewed and individually adjusted during weekly physiotherapy sessions. | Other | Multimodal Respiratory Physiotherapy (IS + PEP) |
| Individualised Exercise Programme (Aerobic and Resistance Training)Participants received a four-week individually prescribed exercise programme combining aerobic and resistance training. Aerobic exercise consisted of walking or cycling for at least 30 minutes per day, five days per week, at moderate-to-vigorous intensity (70-85% of age-predicted maximum heart rate). Resistance training targeted major muscle groups, comprising 2-4 sets of 8-12 repetitions, twice weekly, initially at 40-60% of one-repetition maximum. Exercises were performed independently at home or in community settings, with individual prescriptions reviewed during weekly physiotherapy sessions. | Other | Exercise and Patient Education, Multimodal Respiratory Physiotherapy (IS + PEP) |
| Patient Education ProgrammeParticipants received a four-week patient education programme addressing respiratory anatomy and physiology, potential respiratory consequences of breast cancer treatment, and the benefits of physical exercise for cardiorespiratory function and functional capacity. Education was delivered during weekly face-to-face physiotherapy sessions and supported by printed educational materials. | Other | Exercise and Patient Education, Multimodal Respiratory Physiotherapy (IS + PEP) |
Primary outcome
Recruitment Rate
Time frame: During the recruitment period
Proportion of eligible women who agreed to participate and were enrolled and randomised in the study, expressed as a percentage of all eligible women invited to participate.
Screening-to-Randomisation Yield
Time frame: During the recruitment period
Description Proportion of women randomised into the study relative to the total number of women assessed for eligibility, expressed as a percentage.
Retention Rate
Time frame: From randomisation to the final follow-up assessment (six months after radiotherapy).
Proportion of randomised participants who completed all study assessments, expressed as a percentage of the total number of randomised participants.
Attendance at Face-to-Face Physiotherapy Sessions
Time frame: Throughout the four-week intervention period.
Proportion of individual face-to-face physiotherapy sessions attended relative to the total number of scheduled sessions, expressed as a percentage.
Adherence to the Home-Based Exercise Programme
Time frame: Throughout the four-week intervention period.
Proportion of intervention weeks during which participants achieved the prescribed exercise target of at least 30 minutes per day, five days per week, expressed as a percentage.
Adherence to Respiratory Training
Time frame: Throughout the four-week intervention period.
Proportion of intervention weeks during which participants in the experimental group achieved the prescribed respiratory training target of at least 30 minutes per day, five days per week, expressed as a percentage.
Adverse Events Related to the Intervention (Safety)
Time frame: Throughout the four-week intervention period
Number and proportion of participants experiencing adverse events during the intervention period. Adverse events were recorded and classified according to their type, seriousness, and potential relationship to the study intervention.
10 secondary outcomes
Forced Expiratory Volume in One Second (FEV1)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Forced Vital Capacity (FVC)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Diffusing Capacity of the Lung for Carbon Monoxide (DLCOadj)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Alveolar Volume (VA)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Carbon Monoxide Transfer Coefficient (KCO)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
One-Minute Sit-to-Stand Test (1minSTS)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Six-Minute Walking Distance (6MWD)
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Self-reported physical activity and sedentary time
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Fatigue
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Health-Related Quality of Life
Time frame: Before surgery (T0), after surgery (T1), at 3 months after radiotherapy/before intervention (T2), at 4 months after radiotherapy/after intervention (T3), and at 6 months after radiotherapy (T4). Randomisation occurred between T1 and T2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality. Study findings will be reported in aggregate form.
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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 Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training, Individualised Exercise Programme (Aerobic and Resistance Training) and Patient Education Programme in people with Breast Neoplasms, run by University of Alcala at 1 site in Spain.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 26 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment Rate (time frame: During the recruitment period). The study lists 7 primary outcomes in all. 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 26 Oct 2026.