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COMPLETED
NCT07884968
NA

Multimodal Respiratory Physiotherapy in Women Receiving Radiotherapy for Breast Cancer (RESPIRA-BC)

Sponsor: University of Alcala

View on ClinicalTrials.gov

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. 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.

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2022-03-01

Completion Date

2024-12-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

OTHER

Incentive Spirometry (IS) and Positive Expiratory Pressure (PEP) Training

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.

OTHER

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

Patient Education Programme

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.

Locations (1)

Faculty of Nursing and Physiotherapy, University of Alcalá

Alcalá de Henares, Madrid, Spain