Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05957809 |
| Other study ID # |
2023/68 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2023 |
| Est. completion date |
June 20, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
Feray Güngör, MSc |
| Phone |
02124141500 |
| Email |
feray.gungorr[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
the effectiveness of structured exercise training will be investigated for individuals with
MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the
study will be randomly divided into two groups a Structured Exercise Group (SEG) and a
Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG)
will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with
primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for
postural sway, muscle strength, mobility, dexterity, cognitive function, trunk
strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training
consisting of clinically supervised aerobic exercise and resistance training on unstable
surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes.
Stretching and mobility exercises will be added to warm up and cool down before and after the
program. CG will be on the waiting list during this process. At the end of 8 weeks, both
groups will be reassessed with their initial assessment. After the 8-week program, the SEG
physical activity recommendation will be given and the KG group will continue on the waiting
list, and a follow-up evaluation will be made in the 24th week. This study will allow the
comparison of newly diagnosed individuals with MS who do not have any physical or cognitive
effects on neurological examination and healthy controls with objective and detailed
evaluations, and will also reveal the evidence on the effects of planned structured exercises
specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the
change in the clinical status of individuals with MS who received or did not receive any
exercise training can be interpreted.
Description:
According to the data of the World Multiple Sclerosis (MS) atlas, the incidence of MS in our
country is 51-100/100.000 and it is estimated that there are over 70.000 individuals with MS.
MS continues to be the most common cause of non-traumatic neurological disability in young
adults with its increasing prevalence in our country as well as all over the world. The most
common problems seen in MS are deterioration of balance and postural control, decrease in
muscle strength, gait problems, and cognitive and emotional functions. These effects become
more visible in the later stages of the disease, but a limited number of studies reveal that
there is an insidious progression from the early period. The topographical model of MS
suggests that the burden of disease below the threshold is compensated by functional reserve,
presents no physical problems, and symptoms become evident once the clinical threshold is
crossed. Furthermore, the evidence suggests that disease activity may be continued even
during the relapse-remitting phase of the disease course, highlighting the need for the use
of sensitive outcome measures that can detect early disorders. Therefore, the involvement in
individuals with newly diagnosed MS is ignored because it is not reflected in activities of
daily living, is compensated by functional reserve because it is below the threshold value,
and cannot be detected in the non-objective clinical neurological examination. Rehabilitation
approaches for individuals with newly diagnosed MS are needed in order to benefit from the
protective effects of exercise and to prevent the effects from progressing. Therefore, within
the scope of our proposed project, the effectiveness of structured exercise training will be
investigated for individuals with MS who are newly diagnosed and have no clinical problems.
Individuals with MS included in the study will be randomly divided into two groups a
Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and
follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated
initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG,
and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity,
cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive
structured exercise training consisting of clinically supervised aerobic exercise and
resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session
duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool
down before and after the program. CG will be on the waiting list during this process. At the
end of 8 weeks, both groups will be reassessed with their initial assessment. After the
8-week program, the SEG physical activity recommendation will be given and the KG group will
continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This
study will allow the comparison of newly diagnosed individuals with MS who do not have any
physical or cognitive effects on neurological examination and healthy controls with objective
and detailed evaluations, and will also reveal the evidence on the effects of planned
structured exercises specific to individuals with newly diagnosed MS. During the 24-week
follow-up period, the change in the clinical status of individuals with MS who received or
did not receive any exercise training can be interpreted.
