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Table 1 World Health Organization (WHO) Trial Registration Data Set for PREP trial

From: Does a pulmonary rehabilitation based ERAS program (PREP) affect pulmonary complication incidence, pulmonary function and quality of life after lung cancer surgery? Study protocol for a multicenter randomized controlled trial

Data categoryInformation
Primary registry and trial identifying numberChinese Clinical Trial Registry number: ChiCTR1900024646
Date of registration in primary registry21/07/2019
Secondary identifying numbersN/A
Trial protocol versionVersion 1
Source(s) of monetary or material supportClinical research grant from the Department of Rehabilitation Medicine in the First Affiliated Hospital of Nanjing Medical University (1,200,000 CNY)
Primary sponsorN/A
Secondary sponsorN/A
Contact for public queriesXL, luxiao1972@163.com
Contact for scientific queriesXL, luxiao1972@163.com
Public titlePre- 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 titlePre- 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 recruitmentChina
Health condition(s) or problem(s) studiedComplication 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 criteriaAges 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 typeType: 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 enrolment1/8/2019
Target sample size500
Recruitment statusRecruiting
Primary outcome(s)Post-operative pulmonary complications incidence
Key secondary outcomesPulmonary function, six-minute walking test, health-related quality of life
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