Primary Objective:To evaluate the efficacy of the rehabilitation program currently used for lower limb amputees, by comparing the intensity and efficacy of this program with the ACSM requirements regarding the minimum intensity requirements.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Lower limb amputations
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters measured during training:
maximal oxygen uptake (VO2max in l/min), maximal carbon dioxide output (VCO2max
in l/min), maximal heart rate during (HRmax in beats per minute), heart rate
reserve (HRR), peak power output (PPO in W), maximal workload (W).
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), average
heart rate (HR in beats per minute), oxygen input (VO2 in litre per minute),
carbon dioxide output (VCO2 in litre per minute), anaerobic threshold (AT),
blood pressure (BP in mmHg), breathing frequency (BF in breaths per minute)
maximal ventilation (VE litre per minute), respiratory exchange rate (RER in
%), rate of perceived exertion (RPE in 10 point Borg-scale) and daily activity
log.
Background summary
Lower limb amputation is generally associated with poor physical condition,
reduced physical activity and psychological burdens. Physical activity has a
positive effect on both physical and psychological wellbeing, thus improving
the overall quality of life. Therefore, physical activity and sports is an
essential part of the rehabilitation process of lower limb amputees. The lower
limb amputees follow a rehabilitation program which combines physiotherapy,
walking school and sports. However, it is unknown what the physical activity
level of amputees is during the rehabilitation period. Moreover, it is not
determined whether the current rehabilitation program is in accordance with the
general recommendations in the field, 30 min per day minimal 3 times a week
with a minimum intensity of 60% of the maximum heart rate (ACSM). Therefore the
effectiveness of the program in improving the physical fitness is yet unclear.
Study objective
Primary Objective:
To evaluate the efficacy of the rehabilitation program currently used for lower
limb amputees, by comparing the intensity and efficacy of this program with the
ACSM requirements regarding the minimum intensity requirements.
Secondary Objective(s):
To assess the daily activity levels of lower limb amputees during their
outpatient rehabilitation.
To provide recommendations for the development of a standardized training
protocol, for lower limb amputees, effective in increasing the physical
fitness.
Study design
Within subject design
Subjects will be asked to perform three discontinuous exercises (one
sub-maximal and two maximal tests) on a combined arm-leg ergometer (Cruiser). A
discontinuous incremental test protocol will be used because it is more
effective compared to the continuous protocol.
The sub-maximal test will take place at the beginning of the test period. The
first maximal test will take place two or three days after the sub-maximal test
and the second maximal test will take place six weeks after the first maximal
test. Every test will last for maximum 30 minutes each. These tests will take
place at the Centre for Rehabilitation, UMCG, location Beatrixoord.
Subjects will be asked to report their daily physical activities together with
the rate of perceived exertion and time interval of these physical activities
in a daily activity log.
Additionally they will have to wear a portable heart rate frequency monitor
during their physical activities which take place during their regular visits
at the rehabilitation centre.
Study burden and risks
Nature and extent of burden:
The entire study will take 6 (six) weeks, between inclusion and last maximal
test.
During this time subjects will perform three exercise tests on an combined
arm-leg ergometer. One test will be sub-maximal and the other two will be
maximal tests (until exhaustion). Every test will take maximum 30 minutes.
During their time spent outside the rehabilition centre, subjects will be asked
to report their daily physical activities, together with the rate of perceived
exertion and time interval of these physical activities in a daily activity
log.
Additionally they will have to wear a portable heart rate frequency monitor
during their physical activities, which take place during their regular visits
at the rehabilitation centre.
Risks associated with participation:
All exercise tests will be supervised by a physician, who is familiar with
normal and abnormal response during exercises and is able to prevent adverse
events. All personnel are trained to perform cardiopulmonary resuscitation
(CPR). A defibrillator is available. According to the survey of Myers et al.
(2000), the risks and ratio of serious events is very low in subjects with a
risk of coronary artery disease during exercise testing, 1.2/10.000. Their
conclusion was that exercise testing is a very safe diagnostic tool for this
population.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
* Lower limb amputation, more proximal than the foot
* Subjects are at the beginning of their rehabilitation program
* The amputees follow an outpatient rehabilitation program.
* Subjects are 18 years old or older
* Subjects signed the participation agreement form.
Exclusion criteria
The subjects will be excluded from this study if there is evidence or serious suspicion of coronary disease, stress or test related pain in the chest, untreated symptomatic arrhythmia*s (ventricular tachycardia or any rhythm significantly compromising cardiac function), 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 | NL36816.042.11 |