A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients

Study Overview
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Brief Summary
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This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.

Official Title
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A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: a Randomized Controlled Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Prehabilitation intervention
* Behavioral: Health education control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation Patients scheduled to undergo lung resection surgery at least two weeks from recruitment Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment Patients with no evidence of recurrent or progressive disease Patients aged 18 or above Patients able to communicate in Cantonese, Mandarin, or English Patients is absence of any cognitive impairment Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. [rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection] Exclusion Criteria: Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months Presence of another concurrent, actively treated malignancy Presence of chronic obstructive pulmonary disease Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation intervention<br>Participants in the intervention group will follow a 2-week prehabilitation program before lung resection. | Behavioral: Prehabilitation intervention<br>* Participants will: Receive four supervised exercise classes (twice per week for two weeks); Practice six sessions of home-based exercise (three times per week for two weeks); Practice unsupervised respiratory muscle training (daily for two weeks); Receive usual care.<br>|
| Active Comparator: Health education control<br>Participants in the control group will receive health education classes during 2 weeks before lung resection. | Behavioral: Health education control<br>* Participants will: Receive four health education talks (twice per week for two weeks) Receive usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 6-minute walking distance at 1-month post-surgery |  | Baseline; 1-month post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 6-minute walking distance at post-intervention |  | Baseline; 2 weeks (post-intervention) | 
| Change from baseline 6-minute walking distance at 6-months post-surgery |  | Baseline; 6-months post-surgery | 
| Length of postoperative hospital stay |  | 1-month post-surgery | 
| Postoperative complication |  | 1-month post-surgery | 
| Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at post-intervention |  | Baseline; 2 weeks (post-intervention) | 
| Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 1-month post-surgery |  | Baseline; 1-month post-surgery | 
| Change from baseline functional assessment of cancer treatment - Lung (FACT-L) at 6-months post-surgery |  | Baseline; 6-months post-surgery | 
| Change from baseline international physical activity questionnaire (IPAQ) at post-intervention |  | Baseline; 2 weeks (post-intervention) | 
| Change from baseline international physical activity questionnaire (IPAQ) at 1-month post-surgery |  | Baseline; 1-months post-surgery | 
| Change from baseline international physical activity questionnaire (IPAQ) at 6-months post-surgery |  | Baseline; 6-month post-surgery | 
| Change from baseline daily step count measured by pedometer at post-intervention |  | Baseline; 2 weeks (post-intervention) | 
| Change from baseline daily step count measured by pedometer at 1-month post-surgery |  | Baseline; 1-months post-surgery | 
| Change from baseline daily step count measured by pedometer at 6-months post-surgery |  | Baseline; 6-months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Physical activity, Lung resection, Functional capacity