Status:
COMPLETED
Effect of Aerobic Training vs Balance Training on Fatigue Symptom in Multiple Sclerosis Patient (FATI-gate)
Lead Sponsor:
Istituto Auxologico Italiano
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
Fatigue and impaired balance frequently affect patients with Multiple Sclerosis (MS). This is an open, prospective randomised crossover trial aimed at clarifying whether an improvement in balance cont...
Detailed Description
Fatigue is known to affect patients with Multiple Sclerosis (MS), with a prevalence ranging from 55% to 83%, thus contributing to the level of disability, compromising the Quality of Life, and increas...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary and secondary progressive MS forms are allowed;
- Expanded Disability Status Scale (EDSS) between 2 and 6, included;
- Fatigue as indicated by a total score of mFIS ≥ 20/84;
- Balance impairment as indicated by a performance at the Equitest Sensory Organisation Test below age-matched normal values (95th percentile of control values).
- Exclusion criteria:
- Any of the following in the month before enrolment: an MS relapse; current corticosteroids therapy because of MS; change in medicines prescribed against fatigue; attending an intensive physical therapy program;
- New or active lesions on a brain or spinal cord MRI scan in the 12 months before the study enrolment;
- Angioplasty for chronic cerebrospinal venous insufficiency in the six months before enrolment;
- Any musculoskeletal disease or any additional neurological disorder which causes by itself a balance or gait impairment;
- Any other condition causing fatigue by itself;
- Any unstable cardiological disease.
Exclusion
Key Trial Info
Start Date :
February 17 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06051019
Start Date
February 17 2016
End Date
December 30 2019
Last Update
September 22 2023
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