Table 1.
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 |