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

NCT07884968 | Completed

• 1 other identifier: PIPS-08-2021
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

breast cancer; radiotherapy; respiratory physiotherapy; incentive spirometry; positive expiratory pressure; exercise therapy

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Throughout the four-week intervention period

Secondary Outcomes (10)

• Forced Expiratory Volume in One Second (FEV1)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

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.

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.

Other: Individualised Exercise Programme (Aerobic and Resistance Training); Other: Patient Education Programme

Interventions

Patient Education Programme OTHER

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.

Exercise and Patient Education; Multimodal Respiratory Physiotherapy (IS + PEP)

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

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.

Multimodal Respiratory Physiotherapy (IS + PEP)

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.

Exercise and Patient Education; Multimodal Respiratory Physiotherapy (IS + PEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with unilateral breast cancer.
• Scheduled to undergo breast cancer surgery.
• Adjuvant radiotherapy planned as part of oncological treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Faculty of Nursing and Physiotherapy, University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The random allocation sequence was generated and safeguarded by a researcher who was not involved in participant recruitment, intervention delivery, or outcome assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)