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. 2020 Feb 18;20:44. doi: 10.1186/s12890-020-1073-6

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