|- candidate number||27328|
|- NTR Number||NTR6533|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-mei-2017|
|- Secondary IDs||Geen Secondary ID Pilot niet WMO plichtig|
|- Public Title||Fit4SurgeryTV|
|- Scientific Title||Fit4SurgeryTV: at home prephabiliation for frail elderly diagnosed with colorectal cancer|
|- hypothesis||Multimodal prehabilitation (physical, nutritional, social, psychological) is a potential strategy to convert frail patients to non-frail patients prior to surgery for colorectal cancer.
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Preoperative frailty|
|- Inclusion criteria||All patients >70 years old scheduled for colorectal cancer surgery who are considered to be physically frail, which is defined by the cut-off points as defined by VMS > 0 or ISAR-HP > 1.
|- Exclusion criteria||Exclusion criteria is severe mental of physical incapacity (e.g. severe dementia, bedridden, life expectancy <1 year, metastasised disease) to execute the program.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||29-mei-2017|
|- planned closingdate||1-nov-2017|
|- Target number of participants||15|
|- Interventions||At home fit4surgery tv: |
- daily 7 minute workout
- daily 2x40g protein meal (natural ingredients)
|- Primary outcome||Adherence to program, Fidelity to program|
|- Secondary outcome||Hand Grip Strength, Quality of life, Postoperative complications|
|- Timepoints||Baseline: |
-4 weeks prior to operation
- 1 day prior to operation
- 6 week followup
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Emma Bruns|
|- CONTACT for SCIENTIFIC QUERIES|| Emma Bruns|
|- Sponsor/Initiator ||Gelre hospital Apeldoorn, Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||The Fit4surgery program consists of four parts. In each section, we try to combine the expertise of the scientific basis of the knowledge about implementation with a partner from the private sector.
• FIT: adapted senior seven-minute workout designed especially for frail elderly in collaboration with physical therapists and personal trainers. Here we will work with various physiotherapists and Rockstar Lifestyle, a startup specializing in physical optimisation and uses digital support.
• Food: dietary supplements compiled by researchers at the University of Wageningen, specifically focused on strengthening the older body.9 This is established in collaboration with Albert Heijn. They will provide patients with a special Fit4Surgery-foodbox which contains all the ingredients for the protein-rich diet, including recipes.
• Family & Friends: use of social support that helps gradually during training.10 Family members and friends of the patient are invited to send pictures or support messages during the program.
• Future: prior to the training program chooses a reward after surgery. By means of medals collected on the Fit4SurgeryTV, patients will save for free entrance tickets. There is an established collaboration with the Apenheul. They will provide 120 free tickets.
|- Main changes (audit trail)|
|- RECORD||28-mei-2017 - 15-jul-2017|