Multiple SclerosisFATI-gateNCT06051019
Effect of Aerobic Training vs Balance Training on Fatigue Symptom in Multiple Sclerosis Patient (FATI-gate)
A study testing Aerobic training and Balance training in people with Multiple Sclerosis, run by Istituto Auxologico Italiano.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aerobic training and Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2016to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Comparison Between the Effects on Fatigue of Aerobic Training Versus Balance Training in Patients With Multiple Sclerosis: a Randomised Crossover Trial.
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.
Read the 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).
- Conditions
- Multiple Sclerosis
- Being tested
- Aerobic training, Balance training
- Keywords
- fatigue, balance, multiple sclerosis, aerobic training, balance training
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training (FIRST), then balance training (SECOND) | Experimental | Crossover trial: aerobic training (first treatment), then balance training (second treatment). Receives: Other: Aerobic training; Other: Balance training |
| Balance training (FIRST), then aerobic training (SECOND) | Experimental | Crossover trial: balance training (first treatment), then aerobic training (second treatment). Receives: Other: Aerobic training; Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Scale Italian version
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.
Measured: 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
Secondary outcomes (3)
Equiscale
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.
Measured: 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
Equitest® Sensory Organization Test
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.
Measured: 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
Gait speed
Gait speed measured from the 10-meter walking test.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start17 Feb 2016
- Primary completion30 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Perucca, MD, Study chair, Istituto Auxologico ItalianoAntonio Caronni, MD, Principal investigator, Istituto Auxologico ItalianoStefano Scarano, MD, Principal investigator, Istituto Auxologico ItalianoAntonio Robecchi Majnardi, MD, Principal investigator, Istituto Auxologico ItalianoGiovanna Russo, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051019
- Sponsor's protocol ID
- 24C601
- Acronym
- FATI-gate
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bakshi R, Shaikh ZA, Miletich RS, Czarnecki D, Dmochowski J, Henschel K, Janardhan V, Dubey N, Kinkel PR. Fatigue in multiple sclerosis and its relationship to depression and neurologic disability. Mult Scler. 2000 Jun;6(3):181-5. doi: 10.1177/135245850000600308.
PubMed 10871830Brichetto 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.
PubMed 25392337Flachenecker 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.
PubMed 12474995Giesser BS. Exercise in the management of persons with multiple sclerosis. Ther Adv Neurol Disord. 2015 May;8(3):123-30. doi: 10.1177/1756285615576663.
PubMed 25941539Giovannoni G. Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):2-3. doi: 10.1136/jnnp.2005.074948.
PubMed 16361582Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.
PubMed 23200463Hebert JR, Corboy JR, Manago MM, Schenkman M. Effects of vestibular rehabilitation on multiple sclerosis-related fatigue and upright postural control: a randomized controlled trial. Phys Ther. 2011 Aug;91(8):1166-83. doi: 10.2522/ptj.20100399. Epub 2011 Jun 16.
PubMed 21680771Khan F, Amatya B, Galea M. Management of fatigue in persons with multiple sclerosis. Front Neurol. 2014 Sep 15;5:177. doi: 10.3389/fneur.2014.00177. eCollection 2014.
PubMed 25309504Kos D, Kerckhofs E, Carrea I, Verza R, Ramos M, Jansa J. Evaluation of the Modified Fatigue Impact Scale in four different European countries. Mult Scler. 2005 Feb;11(1):76-80. doi: 10.1191/1352458505ms1117oa.
PubMed 15732270Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
PubMed 6685237Larson RD. Psychometric properties of the modified fatigue impact scale. Int J MS Care. 2013 Spring;15(1):15-20. doi: 10.7224/1537-2073.2012-019.
PubMed 24453758Mayo NE, Bayley M, Duquette P, Lapierre Y, Anderson R, Bartlett S. The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. BMC Neurol. 2013 Jun 28;13:69. doi: 10.1186/1471-2377-13-69.
PubMed 23809312Mills RJ, Young CA. The relationship between fatigue and other clinical features of multiple sclerosis. Mult Scler. 2011 May;17(5):604-12. doi: 10.1177/1352458510392262. Epub 2010 Dec 6.
PubMed 21135018Mostert S, Kesselring J. Effects of a short-term exercise training program on aerobic fitness, fatigue, health perception and activity level of subjects with multiple sclerosis. Mult Scler. 2002 Apr;8(2):161-8. doi: 10.1191/1352458502ms779oa.
PubMed 11990874Rampello A, Franceschini M, Piepoli M, Antenucci R, Lenti G, Olivieri D, Chetta A. Effect of aerobic training on walking capacity and maximal exercise tolerance in patients with multiple sclerosis: a randomized crossover controlled study. Phys Ther. 2007 May;87(5):545-55. doi: 10.2522/ptj.20060085. Epub 2007 Apr 3.
PubMed 17405806
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effects on Fatigue of Aerobic Training Versus Balance Training in Patients With Multiple Sclerosis: a Randomised Crossover Trial.
- ClinicalTrials.gov ID
- NCT06051019
- Acronym / sponsor ID
- FATI-gate / 24C601
- Conditions
- Multiple Sclerosis
- Keywords
- fatigue, balance, multiple sclerosis, aerobic training, balance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic training (FIRST), then balance training (SECOND) | Experimental | Other: Aerobic training, Other: Balance trainingCrossover trial: aerobic training (first treatment), then balance training (second treatment). |
| Balance training (FIRST), then aerobic training (SECOND) | Experimental | Other: Aerobic training, Other: Balance trainingCrossover trial: balance training (first treatment), then aerobic training (second treatment). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingAerobic 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). | Other | Aerobic training (FIRST), then balance training (SECOND), Balance training (FIRST), then aerobic training (SECOND) |
| Balance trainingBalance 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. | Other | Aerobic training (FIRST), then balance training (SECOND), Balance training (FIRST), then aerobic training (SECOND) |
Primary outcome
Modified Fatigue Impact Scale Italian version
Time frame: 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.
3 secondary outcomes
Equiscale
Time frame: 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
Equitest® Sensory Organization Test
Time frame: 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
Gait speed
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 10871830Bakshi R, Shaikh ZA, Miletich RS, Czarnecki D, Dmochowski J, Henschel K, Janardhan V, Dubey N, Kinkel PR. Fatigue in multiple sclerosis and its relationship to depression and neurologic disability. Mult Scler. 2000 Jun;6(3):181-5. doi: 10.1177/135245850000600308.
- Background: PubMed 25392337Brichetto 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.
- Background: PubMed 12474995Flachenecker 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.
- Background: PubMed 25941539Giesser BS. Exercise in the management of persons with multiple sclerosis. Ther Adv Neurol Disord. 2015 May;8(3):123-30. doi: 10.1177/1756285615576663.
- Background: PubMed 16361582Giovannoni G. Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):2-3. doi: 10.1136/jnnp.2005.074948.
- Background: PubMed 23200463Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.
- Background: PubMed 21680771Hebert JR, Corboy JR, Manago MM, Schenkman M. Effects of vestibular rehabilitation on multiple sclerosis-related fatigue and upright postural control: a randomized controlled trial. Phys Ther. 2011 Aug;91(8):1166-83. doi: 10.2522/ptj.20100399. Epub 2011 Jun 16.
- Background: PubMed 25309504Khan F, Amatya B, Galea M. Management of fatigue in persons with multiple sclerosis. Front Neurol. 2014 Sep 15;5:177. doi: 10.3389/fneur.2014.00177. eCollection 2014.
- Background: PubMed 15732270Kos D, Kerckhofs E, Carrea I, Verza R, Ramos M, Jansa J. Evaluation of the Modified Fatigue Impact Scale in four different European countries. Mult Scler. 2005 Feb;11(1):76-80. doi: 10.1191/1352458505ms1117oa.
- Background: PubMed 6685237Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
- Background: PubMed 24453758Larson RD. Psychometric properties of the modified fatigue impact scale. Int J MS Care. 2013 Spring;15(1):15-20. doi: 10.7224/1537-2073.2012-019.
- Background: PubMed 23809312Mayo NE, Bayley M, Duquette P, Lapierre Y, Anderson R, Bartlett S. The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. BMC Neurol. 2013 Jun 28;13:69. doi: 10.1186/1471-2377-13-69.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Perucca, MD study chair
Istituto Auxologico Italiano
Antonio Caronni, MD principal investigator
Istituto Auxologico Italiano
Stefano Scarano, MD principal investigator
Istituto Auxologico Italiano
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Balance training in people with Multiple Sclerosis, run by Istituto Auxologico Italiano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Impact Scale Italian version (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051019, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.