The aim of the study is to assess physical fitness of people in rehabilitation after lower limb amputation and to assess their physical strain during the regular rehabilitation program and specific (physical therapy) sessions of this program.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
beenamputatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aerobic capacity in terms of maximal oxygen uptake (ml/kg/min)
Aerobic strain in terms of heart rate reserve (%heart rate reserve)
Secondary outcome
Exercise capacity in terms of maximal mechanical power, and minimal and maximal
heart rate
Aerobic strain in terms of rating of perceived exertion (Borg scale) and
activity diary.
Walking ability in terms of the SIGAM mobility scales and items scored on the
LCI-5 questionnaire.
Participation in terms of items scored on the USER-P questionnaire.
Background summary
People with a lower limb amputation have a large risk of physical
deconditioning before, during or after amputation. Although the importance of
physical fitness for functioning after amputation is well acknowledged, little
objective data is available on the level of physical fitness and the chage
thereof in people who undergo rehabilitation after lower limb amputation. In
addition, it is unknown what level of physical strain is imposed during regular
rehabilitation and whether this complies with guidelines for improving physical
fitness.
Study objective
The aim of the study is to assess physical fitness of people in rehabilitation
after lower limb amputation and to assess their physical strain during the
regular rehabilitation program and specific (physical therapy) sessions of
this program. Physical strain will be compared to accepted training guidelines
for improving physical fitness. Additionally, it will be investigated how
physical fitness is related to walking ability and general functioning after
rehabilitation.
Study design
Patients will undergo peak exercise capacity testing at two instants during
rehabilitation: at the start and end of the rehabilitation program. In
addition, physical strain imposed on the these patients will be monitored
during a full week at the beginning and end of the rehabilitation program.
Furthermore, a telephone interview will be done half a year and a year after
discharge form clinical rehabilitation to evaluate their functioning on that
moment.
Study burden and risks
The study will take place within the regular rehabilitation program of the
participating patients.
The exercise tests will be administered by experienced therapists and if
necessary supervised by a medical doctor. Absolute and relative contra
indications for maximal exercise test as postulated by the ACSM will be
applied.
During the exercise tests cardiovascular stress will be monitored through blood
pressure and ECG. Safety, feasibility and validity of the protocol has recently
been established (Wezenberg et al 2012). In case of emergency a crash team is
stand by according to regular procedures in both rehabilitation centers.
the assessment of physical strain during rehabilitation with the use of heart
rate monitors will impose negligible burden to the patient.
The burden of the telephone interview done at two moments respectively half a
year and a year after discharge will be a time investment of 10 minutes.
van der Boechorststraat 9
Amsterdam 1081 BT
NL
van der Boechorststraat 9
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Patients with a unilateral amputation of part of the lower limb that will be admitted to the in- or outpatient clinic of the participating rehabilitation centers
Exclusion criteria
serious cardiovascular, neurological or musculoskeletal pathology that imposes a contra-indiaction for the execution of a maximal exercise test.
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 | NL43218.029.13 |