beenamputatie lower extremity amputation lower limb amputation
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Unilateral trans-tibial amputation, knee disarticulation or trans-femoral amputation - LLA > 12 months ago - Function with their own prosthesis in daily life - Cause of amputation; vascular, trauma, infection, cancer - Ambulation level K2, K3 - Written informed consent provided
Exclusion criteria
Exclusion criteria: - Suffering from severe psychiatric illness - Not able to perform a maximum exercise test according to the American College of Sports Medicine (ACSM) guidelines (e.g. recent cardiovascular event, acute pulmonary embolism, blood pressure systolic > 200mmHg/diastolic 120mmHg (www.ASCM.org). This criterion is conform the existing procedure already implemented as care as usual in screening people for performing a CPET in Beatrixoord, Haren (see screening form F4.1) - Suffering from residual limb problems which limit wearing prosthesis at the moment of inclusion - Congenital amputation - K0 / K1 and K4 ambulatory level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility criteria (F3): - For 5 out of 6 of the participants the breaks are adequate in terms of length and frequency (to return to rest metabolism) - 5 out of 6 the participants can complete the entire protocol - The logistics are adequate o 6/6 participants will receive the time schedule at least two weeks in advance o It is clear for 6/6 participants who he/she can call for questions (e.g. about the schedule) o When arriving at UMCG CvR location Beatrixoord, it is clear for 6/6 participants how and where he/she can register o It is clear where for 6/6 participants has to wait before the tests o The planning for space and personal is as it should be in for all the test moments o For 6/6 participants there is a clear end of the testing day with a short evaluation moment with the participant and researcher o The schedule of the test day does not exceed more than 30 minutes due to logistical causes (not based on participant related causes) - No essential data are missing for the analysis, conform previous described study parameters - The dataset in RedCap is complete and usable for analysis for median and interquartile range (IQR) Additionally the items below will be reported and analysed, but will not be used for feasibility criteria. This is because we do not expect these events to happen, but can always occur in any situation. - In case of an event, the crash procedure is followed as already implemented in UMCG CvR location Beatrixoord - Number of falls will be reported and analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Maximum oxygen uptake (VO2-max) expressed in uptake per minute in millilitre per kilogram bodyweight (ml/min/kg) and the commonly used outcome measurements in CPET (e.g. O2 flow, CO2 flow, heart rate, blood pressure, saturation, first and second thresholds, stop reason) - Oxygen uptake (ml/min/kg) in rest and during the specific tests - Heart rate in rest and during the specific tasks - BORG-scale in rest and during the specific tasks - Commonly used outcomes of the 6 MWT, cycling, Glittre-ADL test (walking speed, walking distance, time, steps) - Commonly used outcomes of the ActiGraph (walking speed, walking distance, time, steps, MET-values) | — |
Countries
Netherlands
Outcome results
None listed