Effect of Aerobic Training vs Balance Training on Fatigue Symptom in Multiple Sclerosis Patient (FATI-gate)
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Aerobic trainingOther: Balance training
- Registration Number
- NCT06051019
- Lead Sponsor
- Istituto Auxologico Italiano
- 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 control after balance training would also improve fatigue in patients with MS. Balance training will be compared to aerobic training, which is known to be effective on fatigue.
- 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 increasing the overall treatment costs. For these reasons, fatigue is considered a main target for pharmacological and non-pharmacological therapies for MS.
The physiopathology of fatigue in MS is still not completely understood, and previous research has shown correlations with reduced motor performance, disease progression and depression. Some possible mechanisms of fatigue in MS have been hypothesised but not yet proven, such as structural alterations in the central nervous system, altered immune function in the brain, impaired pituitary gland function, and changes in cardiac or muscle activity.
Patients with MS also frequently show balance impairments, with prevalence peaking at 87.9%, and previous studies have suggested a causal relationship between fatigue and balance deficits.
Therapeutic exercise has shown a key role in contrasting the functional decline and disability secondary to MS. Several studies have evaluated the effects of different types of training, such as balance training and aerobic training, on balance impairment and the overall patient's functional performance.
In the literature, it is not uncommon to observe improvements in fatigue after the administration of exercise therapy targeted at the balance impairment. However, the literature has not yet clarified whether an improvement in balance control after balance training would also result in an improvement in the scales used to measure fatigue.
The aim of this open prospective randomised crossover trial is to compare the effects of two different types of therapeutic exercise, aerobic training (AT) and balance training (BT), in modifying the intensity of fatigue in patients with MS. AT and BT will be administered at different times to the same patients (crossover trial). Both AT and BT will consist of 15 treatment sessions (5 sessions per week). Patients with MS will be randomly assigned to AT or BT in the first treatment period and then switched to the other type of training in the second treatment period. The time interval between the two time periods will last 60 days, during which the patients will not perform any physical exercise.
In each treatment period, the participants will perform three measurement sessions: before intervention (T0), at the end of intervention (T1), and 30 days after the end of intervention (T2).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Balance training (FIRST), then aerobic training (SECOND) Balance training Crossover trial: balance training (first treatment), then aerobic training (second treatment). Aerobic training (FIRST), then balance training (SECOND) Aerobic training Crossover trial: aerobic training (first treatment), then balance training (second treatment). Aerobic training (FIRST), then balance training (SECOND) Balance training Crossover trial: aerobic training (first treatment), then balance training (second treatment). Balance training (FIRST), then aerobic training (SECOND) Aerobic training Crossover trial: balance training (first treatment), then aerobic training (second treatment).
- Primary Outcome Measures
Name Time Method Modified Fatigue Impact Scale Italian version The Modified Fatigue Impact Scale was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention Modified Fatigue Impact Scale (mFIS) Italian version: The Modified Fatigue Impact Scale is a self-administered questionnaire comprising 21 items assessing how often fatigue interferes with everyday life. Modified Fatigue Impact Scale score ranges from 0 to 84, with higher scores indicating more fatigue.
- Secondary Outcome Measures
Name Time Method Equiscale The Equiscale was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention Equiscale: The Equiscale is an eight-item rating scale developed to measure balance in Multiple Sclerosis. Each item is scored on three categories. Scores range from 0 to 16, with higher scores indicating better balance.
Equitest® Sensory Organization Test The Sensory Organization Test was computed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention Equitest Sensory Organization Test (SOT): The Equitest Sensory Organization Test is a posturography test, assessing six different balance conditions. From the six balance tasks, a composite score is obtained from the amplitude of the centre of mass sway during standing, ranging from 0 (i.e., falling) to 100 (i.e., perfect stability), with higher scores indicating better balance.
Gait speed The gait speed was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention Gait speed measured from the 10-meter walking test.