In this randomized controlled trial we study whether physical fitness, physical activity and mobility improve more in recent lower limb amputees that receive an aerobic exercise program of 12 weeks next to the regular rehabilitation program compared…
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Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical Fitness
At T0 and T1 physical fitness will be assessed by a maximal exercise test with
expiratory gas analysis. VO2 max will be determined on a Cruiser ergometer
(Enraf-Nonius, Delft, the Netherlands, 2011), which is a combined arm leg
ergometer. The participant sits on a comfortable seat (low seat height) and
places the foot of the unaffected limb against a non-moving, adjustable
footrest in front. The stump of the amputated limb is placed on a special
support connected to the seat. When a patient with an amputation uses the
Cruiser ergometer without wearing a prosthesis, the residual limb can be
positioned securely on another support especially made for patients with an
amputation. The footrest is used to push the sliding seat backwards and the
patient can move the seat forwards again by pulling the two-lever arm. In this
cyclic process, the sound leg, trunk, and arms are used to provide power output
into the ergometer, and thus the patient exercises (an)aerobically. The
ergometer is set to operate at a constant power between 35 and 60 rpm. Subjects
are instructed to maintain 50 rpm. The accuracy of the Cruiser ergometer is ±
10% for power output and ± 2 rpm for speed. Gas exchange is measured using a
breath-by-breath gas analysis system. At start of the test, expiratory gas
analysis is performed in subjects at rest during three minutes. An educated
ergometry laboratory technician performs the test under supervision of a
physician. Safety will be monitored by means of a 12-lead electrocardiogram
(ECG) and standard cuff blood pressure measurements before and after the
exercise test. The exercise test starts with a workload of 10 Watt and the load
will be increased every minute by 5, 10 or 15 Watt depending on the subject*s
fitness.
Reasons for ending the test are severe fatigue, dyspnoea or not being able to
maintain a cycling rate of 50 rpm on the Cruiser. For safety reasons the
ergometry laboratory technician can discontinue the test in case of ECG
abnormalities or other indications for cardiovascular problems. The
cardiorespiratory variables for physical fitness (VO2 max, RCP, AT) are
measured with Oxycon software.
Secondary outcome
Physical activity
Physical activity is measured by accelerometer and a questionnaire at T0, T1
and T2. Patients will be fitted with an accelerometer (Sensewear-BodyMedia,
Pittsburgh Philadelphia USA). An accelerometer is a small lightweight physical
activity monitor. The subjects will be instructed to wear the accelerometer for
seven consecutive days. Accelerometry has been shown to be a reasonably valid
method to objectively assess physical activity in adults. The accelerometer
will be programmed to measure the time someone*s activity level is * 4
metabolic equivalents. The Metabolic Equivalent Task (MET) is a physiological
measure expressing the energy cost of physical activities. 1 MET is equal to
the energy produced per unit surface area of an average person sealed at rest.
In the Netherlands > 4 MET is considered as moderate-intensive exercise for
adults.
The SQUASH (Short QUestionnaire to ASsess Health enhancing physical activity)
is a commonly used instrument in the Netherlands to assess physical activity.
It was developed by the Dutch National Institute of Public Health and the
Environment (RIVM) to measure physical activity with respect to occupation,
leisure time, household, transportation means and other daily activities. The
SQUASH was designed to give an indication of the habitual activity level and
was structured in such a way that it would be possible to assess compliance to
physical activity guidelines. It has been shown to be valid in measuring
physical activity among the Dutch population.
Mobility
At T0, T1 and T2 we use the Special Interest Group in Amputation Medicine
(SIGAM) scale to measure mobility. This scale, proposed by the British Society
of Rehabilitation Medicine, is a self-administered questionnaire comprising 21
closed questions (yes or no responses). It evaluates walking in terms of help
from others, walking aids, walking distance and ability to walk on different
surfaces and in different meteorological conditions. This questionnaire can be
analysed simply by using a defined algorithm that provides perfect
reproducibility of analysis. This questionnaire also shows good validity as
compared with the Timed Walking Test and the Rivermead Mobility Index and good
sensitivity to change. Therefore, the scale seems appropriate to obtain an
objective clinical description of functional mobility in patients with
lower-limb amputation. We use the Dutch version (SIGAM-WAP).
Background summary
Lower limb amputees experience a decline in physical fitness due to limited
physical activity prior to and after the amputation, cardiovascular disease,
sedentary behavior and smoking habits. Studies demonstrated that
cardiorespiratory fitness in amputees was clearly lower than in able-bodied
individuals. This causes problems in walking with a prosthesis because energy
expenditure in walking with a prosthesis is much higher than in walking with
two sound legs. To walk with a prosthesis at a functional level of activity, it
is very important that the amputee is able to meet the high energy expenditure
demands. Ascending levels of amputation appear to be associated with increased
energy expenditure in walking.
The burden on the cardiorespiratory system of amputees is considerably high,
especially in patients with an amputation due to vascular disease. If it is
possible to improve the physical fitness of the amputee, a reduction of the
burden on the cardiorespiratory system of the amputee can be expected.
Therefore, improvement of physical fitness seems to be an important factor
related to functional outcome of the amputee.
There is strong evidence that aerobic exercise training can result in
improvement in cardiorespiratory fitness and in functional gains. The American
College of Sports Medicine (ACSM) guidelines for persons with chronic diseases
and disabilities, including people with a lower limb amputation recommend that
achieving an aerobic training effect requires exercising of large muscle groups
at a frequency of 3-5 times a week, for a duration of 20-60 minutes at an
intensity of 40-70% heart rate reserve. To provoke an adaptation in
cardiorespiratory fitness it is important to respect these guidelines and apply
them in the rehabilitation program.
Aerobic exercise training may increase the functional walking ability of
amputees. In regular rehabilitation programs physical fitness of amputees is
trained in daily walking courses, sports and during fitness exercises. However,
an individually tailored cardiovascular aerobic exercise program based on the
outcomes of a maximal exercise test is not daily practice.
Whether the current rehabilitation programs are strenuous enough for the
patient to improve cardiorespiratory fitness is unclear. In a study involving
patients after stroke, limb amputation and spinal cord in a clinical
rehabilitation setting was found that these patients experience adequate
cardiorespiratory strain to potentially induce an aerobic training effect. On
the other hand, in a study on lower limb amputees was shown that a training
program that only covers walking training with a prosthesis, did not improve
maximal aerobic capacity to the level of able-bodied persons. After providing
the lower limb amputees with a 12 week aerobic exercise training amputees the
anaerobic threshold (AT) and maximum oxygen uptake (VO2max) increased
significantly compared to their levels before the training, respectively 36.5
and 26.0%, and were similar to able-bodied subjects. However, in this research
only young traumatic amputees were included which is not reflective for the
general amputee population.
Study objective
In this randomized controlled trial we study whether physical fitness, physical
activity and mobility improve more in recent lower limb amputees that receive
an aerobic exercise program of 12 weeks next to the regular rehabilitation
program compared to lower limb amputees that receive only the regular
rehabilitation program. In this study we include lower limb amputees with
different causes of amputation including cardiovascular patients. We
hypothesize that a 12-week cardiovascular aerobic exercise program will lead to
a clinical relevant and significant improvement of physical fitness. Due to
better physical fitness patients will be able to increase their activity level
and mobility.
Primary Objective:
To study the effect of an aerobic exercise program of 12 weeks in recent lower
limb amputees on physical fitness.
Secondary Objective(s):
To study the effect of an aerobic exercise program of 12 weeks in recent lower
limb amputees on physical activity and mobility.
Study design
The study is a randomized controlled study with two arms. Recent unilateral
transtibial, knee exarticulation and transfemoral lower limb amputees referred
for inpatient or outpatient rehabilitation in the UMCG Center for
Rehabilitation will be asked to participate in the study. The participants will
be randomized into the regular rehabilitation program group or the group that
receives an additional cardiovascular aerobic exercise program of 12 weeks.
Stratification will be done for cause of amputation (vascular versus other
cause for amputation), since we expect cardiovascular disease to have an
important influence on the physical fitness. Follow-up measurements will be
performed at 12 and 24 weeks after inclusion.
Intervention
In the intervention group an aerobic exercise program is added to the standard
rehabilitation program. The aerobic exercise program consists of a supervised
training of 12 weeks in the rehabilitation center. The intervention is fully
tailored and based on the patient*s individual aerobic capacity. Before the
exercise training, a symptom-limited maximal exercise test on the combined
arm-leg ergometer, named Cruiser ergometer, will be performed to determine the
respiratory capacity threshold (RCT). The intensity of aerobic training is
prescribed on the basis of RCT. All patients start at 50% intensity according
to the RCT and intensity increases over the ensuing weeks (week 1-4: 50%, week
5-6: 60%, week 7-10: 70% and week 11-12: 75%). When RCT is not reached the
anaerobic threshold (AT) is used for prescription of training intensity with
similar percentages.
Training sessions are performed three times per week for 30 minutes per session
on the Cruiser ergometer and are supervised by experienced physiotherapists.
The aerobic exercise training will include a warm-up before and a cool-down
after the training. After 12 weeks the intervention is finish and patient who
have not reached their rehabilitation goals will continue the regular
rehabilitation program.
Study burden and risks
Subjects included in the intervention group perform aerobic training 3 x 30
minutes per week during 12 weeks . This training is planned during their
regular rehabilitation program. No extra visits to the rehabilitation center
are required. All subjects perform a maximum exercise test at the start and at
12 weeks after inclusion. This test provides important clinical data that form
the foundation for an effective and safe exercise prescription. In case of
abnormalities on the maximum exercise test subjects are referred to a
cardiologist. Risk that a SAE will occur is not higher than in care as usual.
Subjects in the intervention group can benefit from participating in the study
when the aerobic exercise training results in better physical fitness. In
addition, counselling on sports activities during and after finishing the
rehabilitation program can support the subjects in maintaining a healthy and
active life style. We perform the study in recent lower limb amputees since in
this group we expect physical fitness to be reduced importantly due to
immobility. The measurement at 24 weeks will be combined with a regular control
to the rehabilitation center.
Dilgtweg 5
Haren 9750RA
NL
Dilgtweg 5
Haren 9750RA
NL
Listed location countries
Age
Inclusion criteria
- unilateral transtibial, knee exarticulation or transfemoral amputation
- amputation was performed < 6 weeks before inclusion
- motivated for rehabilitation
- intent of functioning with a lower limb prosthesis
- cause of amputation: vascular, infection, trauma or cancer
Exclusion criteria
- serious wound healing problems of the stump that impede the regular rehabilitation program
- severe psychiatric illness
- not able to perform a maximal exercise test, according to ACSM guidelines (e.g. recent cardiovascular event, acute pulmonary embolism, blood pressure systolic > 200 mmHg / diastolic 120 mmHg (www.ACSM.org)
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 | NL65000.042.18 |