Effect of Aerobic Training vs Balance Training on Fatigue Symptom in Multiple Sclerosis Patient (FATI-gate)
NCT ID: NCT06051019
Last Updated: 2023-09-22
Study Results
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Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2016-02-17
2019-12-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Aerobic training (FIRST), then balance training (SECOND)
Crossover trial: aerobic training (first treatment), then balance training (second treatment).
Aerobic training
Aerobic training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Sessions will be performed with the assistance or supervision of a physical therapist and will consist of the following steps: 1) warm up with a stationary bike (no load, 10 min, 60 cycles/min); 2) upper and lower limb stretching (10 min); 3) 10 min rest in a sitting position; 4) first exercise bout: stationary bike, 15 min, 60 cycles/min (the load will be modulated so that the participant's heart rate is between 60 and 70% of the estimated maximum heart rate, and the patient perceives moderate fatigue on the Borg Rating of Perceived Exertion; 5) upper and lower limb stretching (10 min); 6) 10 min rest in a sitting position; 7) second exercise bout (same parameters as the first exercise bout); 8) upper and lower limb stretching (10 min).
Balance training
Balance training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Treatments will be performed with a physical therapist and will consist of the following exercises: 1) standing with feet together, 2) standing with closed eyes, 3) standing on unstable surfaces, 4) standing while performing upper limbs movements; 5) standing while performing head rotations; 6) walking on a treadmill at alternating speeds; 7) leg press and chest press exercises for training trunk balance during ballistic movements of the upper and lower limbs. These constituents of balance training can be combined in the same task according to the participant's ability.
Balance training (FIRST), then aerobic training (SECOND)
Crossover trial: balance training (first treatment), then aerobic training (second treatment).
Aerobic training
Aerobic training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Sessions will be performed with the assistance or supervision of a physical therapist and will consist of the following steps: 1) warm up with a stationary bike (no load, 10 min, 60 cycles/min); 2) upper and lower limb stretching (10 min); 3) 10 min rest in a sitting position; 4) first exercise bout: stationary bike, 15 min, 60 cycles/min (the load will be modulated so that the participant's heart rate is between 60 and 70% of the estimated maximum heart rate, and the patient perceives moderate fatigue on the Borg Rating of Perceived Exertion; 5) upper and lower limb stretching (10 min); 6) 10 min rest in a sitting position; 7) second exercise bout (same parameters as the first exercise bout); 8) upper and lower limb stretching (10 min).
Balance training
Balance training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Treatments will be performed with a physical therapist and will consist of the following exercises: 1) standing with feet together, 2) standing with closed eyes, 3) standing on unstable surfaces, 4) standing while performing upper limbs movements; 5) standing while performing head rotations; 6) walking on a treadmill at alternating speeds; 7) leg press and chest press exercises for training trunk balance during ballistic movements of the upper and lower limbs. These constituents of balance training can be combined in the same task according to the participant's ability.
Interventions
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Aerobic training
Aerobic training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Sessions will be performed with the assistance or supervision of a physical therapist and will consist of the following steps: 1) warm up with a stationary bike (no load, 10 min, 60 cycles/min); 2) upper and lower limb stretching (10 min); 3) 10 min rest in a sitting position; 4) first exercise bout: stationary bike, 15 min, 60 cycles/min (the load will be modulated so that the participant's heart rate is between 60 and 70% of the estimated maximum heart rate, and the patient perceives moderate fatigue on the Borg Rating of Perceived Exertion; 5) upper and lower limb stretching (10 min); 6) 10 min rest in a sitting position; 7) second exercise bout (same parameters as the first exercise bout); 8) upper and lower limb stretching (10 min).
Balance training
Balance training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Treatments will be performed with a physical therapist and will consist of the following exercises: 1) standing with feet together, 2) standing with closed eyes, 3) standing on unstable surfaces, 4) standing while performing upper limbs movements; 5) standing while performing head rotations; 6) walking on a treadmill at alternating speeds; 7) leg press and chest press exercises for training trunk balance during ballistic movements of the upper and lower limbs. These constituents of balance training can be combined in the same task according to the participant's ability.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Principal Investigators
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Laura Perucca, MD
Role: STUDY_CHAIR
Istituto Auxologico Italiano
Antonio Caronni, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
Stefano Scarano, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
Antonio Robecchi Majnardi, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
Giovanna Russo, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
References
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Brichetto G, Piccardo E, Pedulla L, Battaglia MA, Tacchino A. Tailored balance exercises on people with multiple sclerosis: A pilot randomized, controlled study. Mult Scler. 2015 Jul;21(8):1055-63. doi: 10.1177/1352458514557985. Epub 2014 Nov 12.
Flachenecker P, Kumpfel T, Kallmann B, Gottschalk M, Grauer O, Rieckmann P, Trenkwalder C, Toyka KV. Fatigue in multiple sclerosis: a comparison of different rating scales and correlation to clinical parameters. Mult Scler. 2002 Dec;8(6):523-6. doi: 10.1191/1352458502ms839oa.
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Other Identifiers
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24C601
Identifier Type: -
Identifier Source: org_study_id
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