1. To determine the reproducibility of the ECWT and the 6MWT to assess the physical strain of walking in patients with PPS and in healthy control subjects.2. To evaluate the one-year course of the physical strain of walking among patients with PPS…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are speed (in m/min), the 6-minute walking
distance (6MWD in m), heart rate (HR in b/min), and EC walking (in J/kg/m), as
measured with the ECWT. From the 6MWT, speed, 6MWD, and HR will be calculated.
Secondary outcome
Secondary study parameters are the patient*s perceived exertion score (as
measured with the Borg scale), and the patient*s perceived fatigue (as measured
with the FSS, DEFS and CIS).
FSS = Fatigue Severity Scale
DEFS = Dutch Exertion Fatigue Scale
CIS = Checklist Individual Strength
Background summary
Survivors of poliomyelitis may develop new neuromuscular symptoms later on in
life, including new muscle weakness, fatigue and muscle pain. These new
symptoms are referred to as the postpoliomyelitis syndrome (PPS). PPS may cause
increasing difficulties with mobility, by a reduced walking speed and an
increased physical strain of walking, which can be up to 3 times higher,
compared to healthy controls. In the literature, two distinct walking capacity
tests are commonly used to assess the physical strain of walking, including the
6-minute walk test (6MWT) and the energy cost of walking test (ECWT). However,
the reproducibility of both these tests in PPS patients has never been
compared.
Study objective
1. To determine the reproducibility of the ECWT and the 6MWT to assess the
physical strain of walking in patients with PPS and in healthy control subjects.
2. To evaluate the one-year course of the physical strain of walking among
patients with PPS and healthy control subjects, as quantified with the ECWT and
the 6MWT.
3. To determine the relationship between the physical strain of walking and
perceived fatigue in patients with PPS.
Study design
An intra-rater (i.e. between occasions) test-retest reproducibility study will
be conducted at the outpatient clinic of the department of Rehabilitation in
the Academic Medical Center in Amsterdam.
Study burden and risks
Measurements with the ECWT and 6MWT will be performed twice within 2 weeks (at
T0 = 0 weeks (test), at T1 = 2 weeks (retest)). The duration of these tests
will be approximately 45 minutes. Furthermore, at the first visit the patient
is asked to fill in three fatigue questionnaires (FSS, DEFS, and CISr20). The
duration for completing these questionnaires is 10 minutes. Possible medical
risks related to performing the tests are considered minimal. Also, the load
for the patients is low; per visit two sub-maximal walking tests will be
performed (comparable to walking in daily-life), with bouts of (seated) rest in
between the different parts of the experiment.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Patients:
-a confirmed history of paralytic poliomyelitis
-capable of walking independently for more than 150m without any supportive devices
-aged between 18 and 75 years;Control subjects:
-healthy volunteers, matched for age, gender, body weight and height.
Exclusion criteria
Patients en control subjects:
-cognitive impairment
-insufficient mastery of the Dutch language
-impairments that could contra indicate performing a 6-minute walk 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL39153.018.11 |
| OMON | NL-OMON22236 |