Actively Recruiting
A Randomised Controlled Trial to Evaluate the Impact of Thoracic Prehabilitation With Inspiratory Muscle Training Compared to Standard Prehabilitation in People With Lung Cancer for Surgical Treatment
Led by Swansea Bay University Health Board · Updated on 2026-01-30
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with lung cancer who may undergo surgery to remove part of the lung. Surgery offers a chance for cure but can be risky for those with poor lung function or breathlessness. This trial looks at adding a breathing muscle training device to a standard exercise program called Prehabilitation (Prehab) to help improve fitness and reduce complications after surgery. The study compares two groups: one receives the standard Prehab program plus inspiratory muscle training using a hand-held device that strengthens breathing muscles, while the other group receives only the standard Prehab. Both groups will prepare for surgery with these programs. The aim is to see if the added muscle training reduces lung-related complications and hospital stay after surgery. Participants will be followed for up to twelve months after surgery, with regular assessments of breathlessness, quality of life, lung function, activity levels, and hospital outcomes. Researchers will monitor post-procedure complications and recovery progress through tests, questionnaires, and medical records. This detailed follow-up helps understand the benefits and effects of the breathing training device alongside standard care.
CONDITIONS
Brief Title
The PRIMROSE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with lung cancer with surgically resectable disease referred for pre-treatment optimization with Prehab
- Medical Research Council dyspnoea score of 1 or higher
- World Health Organization performance status of 1 or higher
- Age 18 years or older
- Age 70 years or older or frailty index greater than 3
- Borderline or poor lung function with FEV1 or DLCO less than 50%
- Sedentary lifestyle despite adequate lung function
- Eligible for lung surgery including endobronchial excision, lobectomy, segmental resection, pneumonectomy, or wedge resection
- Able to provide verbal and written consent for Prehab and surgery
- No restriction based on baseline respiratory muscle strength
You will not qualify if you...
- Does not meet inclusion criteria
- Diagnosed with other cancers such as metastatic lung cancer, mesothelioma, sarcoma, mediastinal tumors, or benign diseases
- Declines or does not consent to Prehab or surgery
- High cardiovascular risk or awaiting heart investigations or interventions
- Serious disorders compromising safety during Prehab
- Abdominal hernia or recent abdominal surgery
- History of spontaneous pneumothorax or large lung bullae
- Unable to understand written or spoken English without a translator
- Perforated eardrum
- Worsening heart failure symptoms after inspiratory muscle training
- Pulmonary hypertension
- History or risk of costochondritis
- Participation in similar studies causing bias or conflict of interest previously or currently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months prior to surgery
Participants undergo pre-treatment optimization with Standard Prehab, and some receive additional inspiratory muscle training using a device to improve lung function before surgery.
Visits every two weeks during Prehab
Duration - Day of surgery
Participants undergo lung cancer surgical resection after completing Prehabilitation.
1 visit (surgery day)
Duration - Up to 2 months after surgery
Participants are monitored for post-procedure complications and recovery after surgery.
Follow-up visits at hospital discharge and up to 2 months post-procedure
Trial Site Locations
Total: 1 location
1
Swansea Bay University Health Board
Swansea, United Kingdom, SA6 6NL
Actively Recruiting
Research Team
I
Ira Goldsmith, Professor
T
Tracy Jones, Physiotherapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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