Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02874677 |
| Other study ID # |
RC-P0048 |
| Secondary ID |
2016-A00745-46 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 7, 2017 |
| Est. completion date |
January 14, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Lille Catholic University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous
system. In France, it concerns approximately 80 000 patients and represents one of the most
frequent neurological affections in young adults. Effort deconditioning of people affected by
MS is already proven, but it is not just linked to the disease itself. The decrease of
capacities to produce an effort is aggravated by neurovegetative and cardiovascular
disorders. The limitation or the complete stop of physical activity is often linked to the
fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance
disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated
by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and
alter significantly the quality of life.
Some reeducation programs were proposed in hospitalization with some efficiency on functional
capacities. It is now admitted that physical exercise is not noxious, and allows the
implementation of effort reeducation for MS. Randomized controlled studies have shown in MS
patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of
life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort
reeducation on treadmill. Unfortunately, the efficiency of these programs on walking
endurance are controversial.
During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1)
corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows
the precise determination of the limit from which the body is incapable of producing the
necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a
level of load with enough intensity for the subject to support the test without dyspnea. A
VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to
effort due to dyspnea and excessive muscular fatigue. This indication is very informative
about the quality of life of patients.
The goal of this study is to apply a personalized reeducation concerning the working load
pre-hyperventilation to deconditioned subjects, easily worried by effort induced
breathlessness and fatigue in order to get the optimization of the aerobic function. The
hypothesis is that reeducation at this level improves the distance of walking and the quality
of life of patients affected by MS.
Description:
Multiple sclerosis is a disease affecting the white matter of the central nervous system. In
France, it concerns approximately 80 000 patients and represents one of the most frequent
neurological affections in young adults. There are several symptoms, including pyramidal
syndrome, sensory syndrome, visual disorders, fatigue, bladder-sphincter disorders, etc. It
is an unpredictable chronic disease. Most of the time, it evolves by relapse at the
beginning, then, after a few years, the disease becomes secondarily progressive. In some
cases, the evolution is directly progressive.
Efforts oriented to the deconditioning of people affected by multiple sclerosis are already
proven, but they are not only linked to the disease itself. The decrease of capacities to
produce an effort is aggravated by neurovegetative and cardiovascular disorders.
The limitation, even the complete stop, of physical activity is often linked to the fear of a
handicap aggravation. Causes of stop are multiple, including fatigue (general and muscular)
and balance disorders, even if the handicap level is low (average EDSS = 2).
Walking disorders generated by this pathology are frequent and represent the first symptom of
the disease (10 to 20 % of cases). These walking disorders quickly appear and alter
significantly the quality of life.
After several years of evolution, functional effects are more and more pronounced. The
walking perimeter is estimated at 500 meters without help after 7 years of evolution on
average, and no more than 100 meters after 15 years of evolution. At this stage, 50 % of
patients need a technical help to move.
Some reeducation programs were proposed in hospitalization with some efficiency on functional
capacities. It is now admitted that physical exercise is not noxious, and allows the
implementation of effort reeducation for this pathology. Randomized controlled studies have
shown in multiple sclerosis patients an improvement of physical abilities, of O2max (aerobic
capacity), a decrease of fatigue and an improvement of quality of life.
Actually, the cyclo-ergometer is the most common device used for the effort reeducation.
Another approach is the use of a treadmill, based on the improvement of the walking reflex
modeling and the enhancement of the specific walking work, thanks to a high frequency of
repetitions. This device seems more adapted for the improvement of walking disorders than the
cyclo-ergometer.
For this pathology, only a few studies estimated the effect of effort reeducation on
treadmill. Unfortunately, the efficiency of these programs on walking endurance is not well
known and results are controversial. Indeed, only two randomized, controlled trials showed
improvements of the walking speed and the energy cost of walking.
However, the impact on the 2-Minute Walk Test (2MWT) was contradictory, probably due to the
population studied (different EDSS and age) and the training duration (4 weeks Vs 8 weeks).
Moreover, in these studies, the effort intensity is most of time determined from an arbitrary
percentage of the theoretical maximal heart rate (HR) or the VO2max.
The heart rate corresponding to the level of load of the ventilatory threshold (VT) described
by Wasserman and al (1973) could be more efficient to measure the intensity of reeducation,
compared to a heart rate (HR) determined from an arbitrary percentage. Four reasons are
highlighted:
1. The ventilatory threshold represents a well defined metabolic level (individualized
measure)
2. According to the subjects, ventilator threshold is not a constant percentage of "O2max",
and suggests that it is also an individualized measure.
3. During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1)
corresponds to a greater increasing of CO2 compared to O2. The identification of this
threshold allows the precise determination of the limit from which the body is incapable
of producing the necessary energy to realize an effort using the aerobic metabolism.
4. The VT1 is situated at a level of load with enough intensity for the subject to support
the test without dyspnea. A VT1 lower than 40 % of the theoretical VO2 max is considered
as a marker of maladjustment to effort due to dyspnea and excessive muscular fatigue.
This indication is very informative about the quality of life of patients.
