|- candidate number||21583|
|- NTR Number||NTR4940|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jan-2015|
|- Secondary IDs||14.0110 |
|- Public Title||Orthostatic hypotension and rehabilitation.|
|- Scientific Title||Orthostatic hypotension and rehabilitation in patients with hip fractures: a prospective observational study. This study is in collaboration with the ‘STOK study’.|
|- hypothesis||The aim of this observational study is to investigate the relationship between orthostatic hypotension and the rate of successful rehabilitation. A previous study showed that orthostatic hypotension increased the risk for successful rehabilitation, but the definition of successful rehabilitation and other sources of bias may have caused this result. The relationship between rehabilitation, muscle strength and orthostatic hypotension will also be investigated. |
|- Healt Condition(s) or Problem(s) studied||Orthostatic hypotension, Patients admitted to the hospital with a hip fracture.|
|- Inclusion criteria||Older patients (>70 years) admitted to the hospital with hip fractures who are treated with surgery.|
|- Exclusion criteria||- unable to mobilize before hospitalization
- Institutionalized in nursing home facilities before hospitalization
- life expectancy less than 3 months
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-nov-2014|
|- planned closingdate||1-nov-2015|
|- Target number of participants||200|
|- Interventions||- Blood pressure measurements (BP)
- Hand grip dynamometry
|- Primary outcome||- Orthostatic hypotension or orthostatic complaints
- Time to successful rehabilitation. Successful rehabilitation is defined as having the same functional status compared to the prefracture status. Functional status is evaluated using the mobility component of the Barthel index questionnaire.
|- Secondary outcome||- Muscular strength measured by Hand grip dynamometry
- Baseline characteristics like gender, medication, medical history, MMSE, operation and anesthesia technique.
- Fear of Falling and number of fall incidents.
- Groningen Frailty index (GFI)
- Blood Pressure (BP) and Heart Rate
- Successful rehabilitation defined as discharge to patients’ own home or to home for the elderly.
|- Timepoints||- Pre-operative: Barthel questionnaire, GFI, Fear of Falling, Handgrip dynamometry
- post-operatively day 1 or 2: BP
- day of discharge hospital: BP, Handgrip dynamometry, MMSE
- day of discharge nursing home: Barthel, time to successful rehabilitation
- post-operatively 2 months (out-patient department): Barthel questionnaire, GFI, RR, Handgrip dynamometry
- post-operatively 6 and 12 months (questionnaire by telephone): number of fall incidents, Barthel questionnaire.
- Post-operatively 12 months: mortality and re-admissions.
|- Trial web site||-|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc L.C. Hartog |
|- CONTACT for SCIENTIFIC QUERIES||MSc L.C. Hartog |
|- Sponsor/Initiator ||Diabetes Centre, Isala|
(Source(s) of Monetary or Material Support)
|- Brief summary||Orthostatic hypotension is a multifactorial clinical syndrome which occurs when standing blood pressure drops below prestanding levels. Orthostatic hypotension is common among the elderly, but its relation to falls, muscle strength and rehabilitation is not certain. By means of this study we will investigate if orthostatic hypotension is related to successful rehabilitation in patients with hip fractures. Main outcome parameters are orthostatic hypotension or orthostatic complains and muscular strength measured by Hand grip dynamometry. |
|- Main changes (audit trail)|
|- RECORD||16-jan-2015 - 20-apr-2015|