Multimodal Respiratory Physiotherapy Including Incentive Spirometry and Positive Expiratory Pressure for Women Treated for Breast Cancer With Radiotherapy: a Pilot Randomised Controlled Trial.
| Registry | NCT07884968, acronym RESPIRA-BC |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 22 (Actual) |
| Sponsor | University of Alcala (Other) |
| Conditions | Breast Neoplasms |
| Interventions | Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training, Individualised Exercise Programme (Aerobic and Resistance Training), Patient Education Programme (Other) |
| Dates | start 2022-03-01, primary completion 2023-12-01, completion 2024-12-01, first posted 2026-10-21, last updated 2026-10-21 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Neoplasms All trials of Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training All trials of Individualised Exercise Programme (Aerobic and Resistance Training)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 Programme | 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. |
| Exercise and Patient Education | Active comparator | 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. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Women with unilateral breast cancer. * Scheduled to undergo breast cancer surgery. * Adjuvant radiotherapy planned as part of oncological treatment. Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Nursing and Physiotherapy, University of Alcalá | Alcalá de Henares, Madrid | Spain |