Effect of home-based walking exercise and education on early functional recovery after lung cancer surgery: protocol for the WalkLung multicentre randomised controlled trial.

Introduction
Lung cancer is the most commonly diagnosed malignancy worldwide.1 Surgical resection is currently the primary curative treatment for patients with early stage lung cancer.2 However, patients undergoing lung resection often experience multiple postoperative symptoms that significantly delay recovery.35 There is, therefore, an urgent need for effective postoperative rehabilitation strategies, such as structured exercise programmes, to accelerate recovery and improve outcomes.
Exercise has been recognised as a core component of cancer rehabilitation.6 Growing evidence suggests that appropriately designed exercise interventions can significantly enhance postoperative recovery in patients with lung cancer.7 Multiple randomised controlled trials (RCTs) have demonstrated that postoperative exercise programmes improve physical fitness and cardiopulmonary function, help alleviate fatigue and pain, promote wound healing through enhanced circulation and may reduce postoperative complications.811
However, despite these well-established benefits, the actual participation rate in postoperative exercise among patients with lung cancer remains low.12 Many programmes rely on specialised equipment, trained staff and incur high costs, thereby limiting accessibility for most patients; observational data show that about 60% of patients fail to meet recommended physical activity levels after surgery.1315 Walking, a low-risk activity, is not only accessible to most individuals regardless of socioeconomic status or location but also offers a wide range of health benefits, including reductions in blood pressure, improvements in physical function and alleviation of symptoms like depression and anxiety.16 17
Although the general health benefits of walking are well documented, there is limited evidence specifically supporting its role in postoperative recovery for lung cancer. To date, only one small-sample observational study has compared early postoperative walking to usual care in this population.18 No RCTs have yet established the efficacy of early walking interventions in enhancing recovery after lung cancer surgery. Therefore, this study aims to address this gap by developing and evaluating a home-based walking exercise and education programme for early postoperative rehabilitation after lung cancer surgery. We hypothesise that this intervention will significantly improve patients’ functional recovery within 4 weeks after discharge.

Methods and analysis

Study design and population
This study is a multicentre, randomised, parallel-controlled trial focusing on patients who underwent lung cancer surgery. The inclusion and exclusion criteria are detailed in table 1. The study flow diagram is presented in figure 1. This study protocol complies with Standard Protocol Items: Recommendations for Interventional Trials 2025 reporting standards.

Patient and public involvement
Patients were involved in aspects of study design, recruitment and implementation, including pilot testing of the individualised walking programme to assess feasibility, adherence and acceptability. Members of the general public were not involved in the design and conduct of this study.

Setting
The participating hospitals in this study include Sichuan Cancer Hospital, Zigong First People’s Hospital and Ya’an People’s Hospital, each of which performs more than 500 lung cancer surgeries annually. Patients will be screened and enrolled between surgery and hospital discharge. The trial is ongoing. The recruitment phase is scheduled from July 2025 to December 2025, and follow-up will be completed from January 2026 to June 2026. Each participant will be followed for a minimum of 1-month and up to 6-months postdischarge. Eligible patients will receive detailed information about the study. Informed consent will be obtained from those who fully understand the study and voluntarily agree to participate (online supplemental file 1). If a patient is unable to write, the informed consent form will be signed by a legally authorised representative.

Randomisation and blinding
Randomisation will be conducted centrally, with stratification by study centre. Eligible participants will be randomised in a 1:1 ratio to the intervention group, which will receive the home-based walking exercise and education programme, or to the control group, which will receive usual care. The randomisation sequence, prepared in advance by system administrators, is embedded in the central electronic data capture (EDC) system. Research staff at each centre will screen patients and obtain consent, after which allocation will be retrieved from the EDC system. The clinical team has no access to the randomisation list.
Because of the behavioural nature of the intervention, blinding participants and treating clinicians is not feasible. To minimise potential bias, however, outcome assessors and statisticians will remain blinded to group assignment during data collection and analysis.

Intervention and control
The intervention is summarised in table 2. Patients in the intervention group will receive a home-based walking exercise and education programme from discharge to 4 weeks. Before discharge, thoracic surgeons and nursing staff will provide walking education and develop an individualised exercise plan according to each patient’s condition and the postoperative walking manual (tables3 4). Age-stratified targets in the walking manual were developed as a pragmatic, easily operationalised approach to standardise a minimum starting prescription across centres in the early postdischarge period, recognising that age generally correlates with functional capacity. Similar age-informed approaches have been used in prior walking-based intervention trials and protocols to guide initial walking prescriptions.19 Importantly, the prescription remains individualised and will be reviewed and adjusted during the follow-up period based on each participant’s baseline functional status, symptoms, comorbidities and response to training. A weekly telephone follow-up will be conducted for 4 weeks to review progress, adjust the exercise prescription and guide exercise progression. No further intervention will be provided after the 4-week period, but follow-up will continue as scheduled.
Patients in the control group will receive usual care during the early postoperative period (within 4 weeks after discharge), which includes standard discharge education covering topics, such as diet, physical activity and wound care. They will not receive the walking manual or telephone guidance.

Outcomes and measures
The outcomes, definitions, measurement tools and assessment time points are presented in table 5.

Primary outcome and measures
The primary outcome is the longitudinal walking difficulty score within 4 weeks after discharge. Patients will complete the perioperative symptom assessment for lung surgery (PSA-Lung)—a validated instrument—at discharge and at weeks 1, 2, 3 and 4 after discharge, via electronic formats.20 The PSA-Lung includes seven symptom items (pain, cough, shortness of breath, disturbed sleep, fatigue, drowsiness and distress) and two functional items (walking difficulty and difficulty with daily activities). Each item is rated on a scale from 0 to 10, with lower scores indicating milder symptoms or better functional status.

Secondary outcomes and measures
6-min walk test (6MWT): the 6-min walking distance will be assessed at 4-weeks postdischarge according to the American Thoracic Society guidelines.21

Pulmonary function: forced vital capacity, forced expiratory volume in 1 s (FEV₁) and percentage of predicted FEV1 will be assessed at discharge and at 4-weeks postdischarge using a handheld spirometer. Two resting measurements will be averaged.

Complications: complications will be classified using the Clavien–Dindo system,22 based on the definition of complications in the Chinese ‘Standardised Diagnosis and Treatment Terminology for Thoracic Diseases’, and the incidence of ≥I grade complications will be calculated from discharge to 4-weeks postdischarge.

Physical activity level: physical activity over the prior week will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at 4 weeks. Metabolic equivalent minutes (MET-minutes) will be calculated, and activity level categorised as low, moderate or high.23 The IPAQ-SF assesses past-week activity across walking, moderate and vigorous domains. Weekly energy expenditure is calculated, and total MET-minutes will be used to classify activity level.

Quality of life: the EuroQol 5-dimension 5-level will be administered at discharge and weekly for 4 weeks. Five health domains will be scored across five severity levels.24

Social functioning: patients will complete the social functioning module of the Postoperative Rehabilitation Assessment - Lung Cancer (PRA-Lung-SO-5) at discharge and at weeks 1, 2, 3 and 4 postdischarge via electronic, paper-based or telephone formats. The PRA-Lung-SO-5 includes five items (work return difficulty, limited social support, affected family roles, reduced social/recreational engagement and financial burden), each scored from 0 to 10. Lower scores indicate less impairment. Social functioning will be analysed longitudinally over the 4-week period.

Exercise adherence: adherence will be monitored through an electronic walking diary, which will record patients’ daily walking duration, distance and speed.

Adverse events: adverse events will be evaluated using the common terminology criteria for adverse events, V.5.0.25

Long-term outcomes: patients will be followed up at 3- and 6-months postdischarge to complete patient-reported outcome (PRO) assessments only. These data will be considered exploratory long-term outcomes and will be reported separately.

Data collection, management and monitoring
An EDC system will be used for primary data collection and management. Walking activity data will be collected using the activity tracker provided to patients and recorded through the daily completion of an electronic walking diary by the patients. To ensure data quality, the EDC system includes an audit trail that automatically records the user ID and timestamp for every data entry or modification, thereby enhancing transparency and facilitating oversight by research governance bodies. A data manager from the coordinating centre will remotely monitor data entry and protocol adherence at each participating site. In addition, data verification will follow a structured process involving single data entry, secondary checks, built-in logical verification and random sampling audits. Once data verification is complete, all researcher access to the system will be disabled to ensure data integrity and security.

Sample size calculation
The primary outcome of this study is the longitudinal walking difficulty score within 4 weeks after discharge. Based on a secondary analysis of data from our previously published cohort study,26 the SD of the walking difficulty score over the 4-week postdischarge period was approximately 1.6 (these descriptive statistics from the secondary analysis are unpublished). Using a sample size calculation formula for repeated-measures design in longitudinal comparisons between two groups (figure 2) and assuming a two-sided α of 0.05 and a power (1−β) of 90% (β=0.1), we estimated that a difference of 0.5 SD between the intervention and control groups (representing the minimal clinically important difference) would be clinically relevant. Each patient is scheduled to provide four repeated measurements (one time a week during the 4 weeks after discharge), and an intraindividual correlation coefficient (ρ) of 0.4 is assumed for repeated measures. Based on these parameters, a minimum of 46 patients per group is required. Accounting for a 20% attrition rate, at least 58 patients per group are needed (46/0.8), resulting in a total sample size of at least 116 participants.

Statistical analysis
An intention-to-treat approach will be used for the primary analysis and a per-protocol analysis will be conducted as a sensitivity analysis. Missing PRO data will not be imputed to avoid potential bias, and analyses will be performed using available cases only. All statistical analyses will be conducted using SAS V.9.4. Group allocation will remain blinded to the data analysts. Categorical variables will be presented as absolute numbers (percentages). Continuous variables will be expressed as mean±SD if normally distributed or as median with IQR if non-normally distributed. Between-group differences in demographic characteristics, disease profiles and non-longitudinal outcomes will be assessed using t-tests or χ2 tests, as appropriate. Longitudinal outcomes (eg, walking difficulty, quality of life and social functioning) will be analysed using generalised estimating equations to account for repeated measures over time.27 All statistical tests will be two sided, and a p value of <0.05 will be considered statistically significant.

Ethics and dissemination
This study was approved by the Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital on 23 April 2025 (No. SCCHEC-02-2025-091). Ethics approval has also been obtained at all participating subcentres. All recruited patients will be required to provide written informed consent. Any subsequent amendments to the protocol will be submitted for further review and approval. The results of this study will be disseminated through peer-reviewed publications and academic conferences.

Supplementary material
10.1136/bmjopen-2025-112444online supplemental file 1