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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 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