lower limb amputation
Conditions
Interventions
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 rehabilitatio
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - unilateral transtibial, knee exarticulation or transfemoral amputation - amputation was performed
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 th | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 con | — |
Countries
Netherlands
Outcome results
None listed