An interventional study of Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training and Individualised Exercise Programme (Aerobic and Resistance Training) in Breast Neoplasms, sponsored by University of Alcala. Completed at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Alcala · Not applicable, Interventional, and Supportive care
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 22 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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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.
Other: Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training · Other: Individualised Exercise Programme (Aerobic and Resistance Training) · Other: Patient Education Programme
Participants received a four-week programme comprising patient education and individually prescribed aerobic and resistance exercise.
Other: Individualised Exercise Programme (Aerobic and Resistance Training) · Other: Patient Education Programme
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the four-week intervention period
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).
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)
Forced vital capacity (FVC) was assessed using spirometry and expressed as a percentage of the predicted value (% predicted).
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)
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).
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)
Alveolar volume (VA) was assessed during the single-breath lung diffusion test and expressed as a percentage of the predicted value (% predicted).
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)
Carbon monoxide transfer coefficient (KCO) was assessed using the single-breath lung diffusion test and expressed as a percentage of the predicted value (% predicted).
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)
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.
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)
Functional capacity was assessed using the six-minute walk test (6MWT). The total distance walked in six minutes was recorded in metres.
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
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).
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
It was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-FS).
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
It was assessed using the Functional Assessment of Cancer Therapy-Breast questionnaire
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
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Dec 2023, 21 months.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 21 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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