WHO trial registration data set (V.1.3.1)
| Data category | Information32 |
| Primary registry and trial identifying number | ClinicalTrials.gov (NCT03369080) and (NCT03689023) |
| Date of registration in primary registry | 12 November 2017 and 26 September 2018 |
| Secondary identifying numbers | The Committees on Health Research Ethics in the Capital Region of Denmark on 10 July 2018 (Journal-nr.: H-18018325) and the Danish Data Protection Agency (j.nr. VD-2018–380, I-Suite nr.: 6631) and (RH-2017–345, I-Suite nr.: 06052) |
| Source(s) of monetary or material support | This work was supported by a mutual cooperation about the research programme ‘Centre for Integrated Rehabilitation of Cancer Patients (CIRE)—Neuro/Psychology,’ between the University Hospitals Centre for Health Care Research, University hospital Copenhagen, Rigshospitalet, University College Copenhagen, Department of Nursing and Nutrition, and the NeuroScience Centre, Rigshospitalet |
| Primary sponsor | This work was supported by a mutual cooperation about the research programme ‘Centre for Integrated Rehabilitation of Cancer Patients (CIRE)—Neuro/Psychology,’ between the University Hospitals Centre for Health Care Research, University hospital Copenhagen, Rigshospitalet, University College Copenhagen, Department of Nursing and Nutrition, and the NeuroScience Centre, Rigshospitalet |
| Secondary sponsor(s) | |
| Contact for public queries | Nicolaj Jersild Holm (nicolaj.jersild.holm@regionh.dk), phone: +45 38631963, Rigshospitalet, Neuroscience Center, Clinic for Spinal Cord Injuries, Havnevej 25, 3100, Hornbæk, Denmark |
| Contact for scientific queries | Nicolaj Jersild Holm (nicolaj.jersild.holm@regionh.dk), phone: +45 38631963, Rigshospitalet, Neuroscience Center, Clinic for Spinal Cord Injuries, Havnevej 25, 3100, Hornbæk, Denmark |
| Public title | Health promotion and cardiovascular risk reduction in people with spinal cord injury—physical activity, healthy diet and maintenance after discharge: study protocol for a national cohort study followed by a clinical intervention study |
| Scientific title | Health promotion and cardiovascular risk reduction in people with spinal cord injury—physical activity, healthy diet and maintenance after discharge: study protocol for a prospective national cohort study followed by a preintervention and postintervention study |
| Countries of recruitment | Denmark |
| Health condition(s) or problem(s) studied | Spinal cord Injury and the cardiovascular risk factor, including weight gain and consequences of an inactive lifestyle during and after the primary rehabilitation |
| Intervention(s) | A controlled premultimodal and postmultimodal pragmatic clinical intervention study, with 6 months of follow-up containing ‘new usual care’ consisting of a uniform and systematic institutional strategy incorporating targeted strategic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process |
| Comparator: a historic control conducted as a national prospective cohort study before ‘new usual care’ | |
| Key inclusion and exclusion criteria | Inclusion criteria: all patients who are 18 years or older, and with a spinal cord injury (SCI) within the last 12 months and admitted at clinic for spinal cord SCIs, are included regardless of aetiology to the SCI, neurological level or completeness of the lesion if informed consent is retrieved |
| Exclusion criteria: exclusion criteria for VO2peak test in the study includes motor complete SCI at C4 level or above, and assisted ventilatory function. Other exclusion criteria are the presence of decubitus, severe spasticity or musculoskeletal problems considered at risk of aggravation during testing or preventing completion of the VO2peak test | |
| Study type | Interventional: the study consists of a primary study designed as a controlled preclinical and postclinical intervention study and a historic control conducted as a prospective cohort study |
| Allocation: the intervention in the primary study is a part of new standard care. Therefore randomisation or blinding is not appropriate | |
| Primary purpose: prevention | |
| Date of first enrolment | November 2017 |
| Target sample size | 160 |
| Recruitment status | Recruiting |
| Primary outcome(s) | Oxygen uptake measured as VO2peak |
| Key secondary outcomes | Body mass index, body composition (determined by dual energy X-ray absorptiometry), metabolic profile consisting of C reactive protein as a marker for inflammation, lipid profile describing total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol and haemoglobin A1c as a marker for carbohydrate metabolism, and blood pressure |
| Ethics Review | The project is approved by the Committees on Health Research Ethics in the Capital Region of Denmark on 10.07.2018 (Journal-nr.: H-18018325) |
| Completion data | June 2020 |
| IPD sharing statement | Data can be accessed by request to the corresponding author after publications related to the PhD project are made |