Table 1.
World Health Organization (WHO) Trial Registration Data Set for PREP trial
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | Chinese Clinical Trial Registry number: ChiCTR1900024646 |
| Date of registration in primary registry | 21/07/2019 |
| Secondary identifying numbers | N/A |
| Trial protocol version | Version 1 |
| Source(s) of monetary or material support | Clinical research grant from the Department of Rehabilitation Medicine in the First Affiliated Hospital of Nanjing Medical University (1,200,000 CNY) |
| Primary sponsor | N/A |
| Secondary sponsor | N/A |
| Contact for public queries | XL, luxiao1972@163.com |
| Contact for scientific queries | XL, luxiao1972@163.com |
| Public title | Pre- and post-operative physiotherapy for the prevention of complications and the improvement of pulmonary function and quality of life after lung cancer surgery: a multi-center randomized controlled trial |
| Scientific title | Pre- and post-operative physiotherapy for the prevention of complications and the improvement of pulmonary function and quality of life after lung cancer surgery: a multi-center randomized controlled trial |
| Countries of recruitment | China |
| Health condition(s) or problem(s) studied | Complication incidence, pulmonary function and quality of life following lung cancer surgery |
| Intervention(s) | Active comparator: Education booklet combined with a 30-min pre-operative pulmonary rehabilitation training session and daily post-operative pulmonary rehabilitation |
| Placebo comparator: Education booklet | |
| Key inclusion and exclusion criteria | Ages eligible for study: 18-80 yr |
| Sexes eligible for study: both | |
| Accepts health volunteers: No | |
| Inclusion criteria: (i) diagnose with lung cancer through medical history, clinical symptoms, radiographic assessment and pathological results; (ii) Karnfsky ≥60 and estimated survival period > 6 months; (iii) to undergo minimally invasive lung cancer surgery (namely the video-assisted thoracoscopic surgery, VATS); (iv) with normal cognitive function and being able to cooperate with the rehab training; (v) the participation in the PREP trial and sign the informed consent form | |
| Exclusion criteria: (i) refuse the randomization; (ii) with severe limb dysfunction or systemic diseases and being unable to cooperate with the rehab training; (iii) with severe cognitive and mental dysfunctions; (iv) participated in other trials previously | |
| Study type | Type: Pragmatic, investigator-initiated, multi-center, randomized controlled, parallel group, clinical trial |
| Allocation: Concealed randomization | |
| Intervention model: Parallel assignment | |
| Masking: Assessor, surgeon, data analyst, and statistician blinded | |
| Primary purpose: Prevention and improvement | |
| Phase: Phase III | |
| Date of first enrolment | 1/8/2019 |
| Target sample size | 500 |
| Recruitment status | Recruiting |
| Primary outcome(s) | Post-operative pulmonary complications incidence |
| Key secondary outcomes | Pulmonary function, six-minute walking test, health-related quality of life |