To evaluate the long term changes in quadriceps muscle function in patients with PPS in comparison with control subjects. To correlate changes in muscle strength, functioning and symptoms with changes in motor unit size. To evaluate long-term…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in maximal quadriceps strength and motor unit size since baseline
measurements 10 years ago.
Secondary outcome
Secondary parameters are changes in walking capacity, daily walking activity,
physical functioning, fatigue and additional motor unit characteristics.
Background summary
New muscle weakness is a frequent complaint among patients with
Postpoliomyelitis Syndrome (PPS).Currently, there is contradictory evidence as
to the rate of progression and cause of muscle weakness in post-polio syndrome.
High-quality long term studies are scarce and although they have looked at
changes in symptomatic patients they did not focus on changes in symptomatic
muscles. For a better understanding of the pathophysiology and progression of
muscle weakness in PPS, changes in motor units and muscle strength of large
symptomatic muscles important for physical functioning need to be studied. In
1999 we investigated motor unit characteristics and muscle strength of
symptomatic quadriceps muscles in 60 patients with post polio syndrome (PPS)
and 20 healthy control subjects. Investigating changes in muscle strength and
motor units in this cohort after 10 years will provide unique data on long-term
changes in neuromuscular function in PPS that will contribute to a better
understanding of the progression and pathophysiology of PPS.
The hypotheses are as follows: 1) muscle strength and motor unit size of
symptomatic quadriceps muscles decline in post-polio syndrome patients at a
faster rate than in age-and sex-matched control subjects; 2) a decline in motor
unit size is associated with a decline in muscle strength and functional
abilities and an increase in symptoms of PPS; 3) motor unit characteristics
besides size will show more long term changes associated with dysfunction in
PPS patients than in controls.
Study objective
To evaluate the long term changes in quadriceps muscle function in patients
with PPS in comparison with control subjects. To correlate changes in muscle
strength, functioning and symptoms with changes in motor unit size. To evaluate
long-term changes in a variety of motor unit characteristics other than size.
Study design
Prospective cohort study. Long term follow-up.
Study burden and risks
There is no direct benefit to the participants of the study. Possible burden
can be the time invested (2 visits, in total 3-4 hours, travelling to Amsterdam
and Nijmegen, possibly getting muscle soreness after the muscle strength tests
and possibly finding the electrical stimulation test unpleasant. These
complaints, that can be caused by the testing procedure, are all temporary and
none are harmful in the long-term. There are no specific risks associated with
the study.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
(1) All PPS subjects who participated in the trial by Horemans et al in 1999-2000*
(2) All controls who participated in the study described by Drost et al in the same period**;* Horemans HL, Nollet F, Beelen A et al. Pyridostigmine in postpolio syndrome: no decline in fatigue and limited functional improvement. J Neurol Neurosurg Psychiatry. 2003;74:1655-1661
**Drost G, Stegeman DF, Schillings ML et al. Motor unit characteristics in healthy subjects and those with postpoliomyelitis syndrome: a high-density surface EMG study. Muscle Nerve. 2004;30:269-276.
Exclusion criteria
All participants of the trials of Horemans et al and Drost et al are eligible for participation unless they suffer from:
(1) Legal incompetence (incapacity), e.g. due to dementia
(2) Motor neuron disease or neurological disease that affects voluntary control of the quadriceps muscle under investigation.
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 | NL31665.018.10 |