Skip to main content
. 2023 Nov 27;24:757. doi: 10.1186/s13063-023-07705-2

Table 1.

Trial registration data set

Data category Information
Primary registry and trial identifying number

International Clinical Trials Registry Platform

NL9793

Date of registration in primary registry 14 October, 2021
Secondary identifying numbers NL78840.029.21
Source(s) of monetary or material support Amsterdam UMC, location VUmc, department of Rehabilitation
Primary sponsor Amsterdam UMC, location VUmc, department of Rehabilitation
Secondary sponsor(s) Amsterdam Movement Sciences Institute
Contact for public queries MdL, m.e.deleeuwerk@amsteramumc.nl
Contact for scientific queries

MdL, m.e.deleeuwerk@amsteramumc.nl

Amsterdam UMC, location VUmc, department of Rehabilitation, Amsterdam, The Netherlands

Public title Optimal Physical Recovery After Hospitalization (OPRAH study)
Scientific title The efficacy of a blended intervention to improve physical activity and protein intake for optimal physical recovery after oncological gastrointestinal and lung cancer surgery: study protocol for a randomized controlled multicenter trial
Countries of recruitment The Netherlands
Health condition(s) or problem(s) studied Rehabilitation after oncological surgery
Intervention(s) Intervention: Smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge
Control: Usual care
Key inclusion and exclusion criteria

Ages eligible for study: ≥ 18 years

Sexes eligible for study: both

Accepts healthy volunteers: no

Inclusion criteria: adult patient (≥ 18 years), scheduled for curative intent surgery for gastrointestinal cancer, including esophageal and stomach cancer (upper GI), colorectal and hepato-pancreato-biliary (HPB) cancer, or lung cancer with a planned hospital stay of ≥ 2 nights, able to fill in online questionnaires in Dutch and give informed consent
Exclusion criteria: pulmonary wedge resection, surgery with open/close procedure, having no access to a mobile device compatible for applications, less than 5 days between inclusion and surgery, patients who are wheelchair dependent, a Mini-Mental State Examination (MMSE) ≤ 24 and already participating in a conflicting study
Study type Multicenter randomized controlled intervention trial with allocation at level of the individual
Allocation: randomized
Primary purpose: treatment
Phase III trial
Date of first enrolment June 2022
Target sample size 161
Recruitment status Recruiting
Primary outcome(s) Recovery in physical functioning six months after hospital discharge
Key secondary outcomes Physical activity, lean body mass, pain, fatigue, muscle mass, protein intake, physical performance, patient-specific activity limitations, self-efficacy, participation in social roles and activities, generic quality of life, global perceived effect, hospital readmission and adverse events