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 | |
Contact for scientific queries | |
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 |