The first aim of this study is to evaluate 1) the feasibility and 2) repeatability of a new exercise test protocol to measure the pysical fitness of persons with a lower limb amputation on the combined arm-leg (Cruiser) ergometer.
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone disorders (excl congenital and fractures)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximal oxygen uptake (VO2max in l/min)
Secondary outcome
Gross Efficiency (% of external work performed to the total production of
energy), metabolic equivalent of exercising (MET in 3.5 ml O2 /kg/min),
maximal carbon dioxide output (VCO2 in liters per minute), heart rate (HR in
beats per minute), maximal workload (W),blood pressure (BP in mmHg), breathing
frequency (BF in breaths per minute) maximal ventilation (VE liters per
minute), respiratory exchange rate (RER in %) and rate of perceiverd exertion
(RPE in 10 point borg-scale)
Background summary
In studies conducted to gain more knowledge about the maximum oxygen uptake and
efficiency of movement in lower limb amputees, many different methods, tests
and outcome variables are used. On this moment there is no appropriate and
repeatable test protocol available to measure the physical fitness in patients
with a lower limb amputation
Study objective
The first aim of this study is to evaluate 1) the feasibility and 2)
repeatability of a new exercise test protocol to measure the pysical fitness of
persons with a lower limb amputation on the combined arm-leg (Cruiser)
ergometer.
Study design
Whitin subject design
Study burden and risks
After inclusion, subjects are asked to perform a submaximal exercise test and
three peak (maximal) exercise tests on the Cruiser ergometer following a
continuous exercise protocol. These trials will be conducted on three days with
1-2 weeks in between. The first trial will take about one hour, the other two
trials will take half an hour.
Prior to testing, subjects will be screened for contraindications to peak
exercise. During all tests supervision will be present, familiar with adverse
events. Risks concerning exercise testing are proven to be very small.
Dilgtweg 5
9751 ND Haren
NL
Dilgtweg 5
9751 ND Haren
NL
Listed location countries
Age
Inclusion criteria
Patients with a lower limb amputation (unilateral transfemoral amputation, knee disarticulation or transtibial amputation).
Exclusion criteria
The subjects will be excluded from this study if there is evidence or serious suspicion of coronary disease, stress or exercise related pain in the chest, untreated symptomatic arrhythmia*s (ventricular tachycardia or any rhythm significantly compromising cardiac function), hypertension with a diastolic bloodpressure of > 100 mm Hg or systolic bloodpressure > 180 mm Hg, acute pulmonary embolus, bilateral lower limb amputations or upper limb amputation, mental impairment leading to inability to cooperate or inability to obtain consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34139.042.11 |