Effect of Aerobic Training vs Balance Training on Fatigue Symptom in Multiple Sclerosis Patient (FATI-gate)

NCT06051019 | Completed

• 1 other identifier: 24C601
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

fatigue; balance; multiple sclerosis; aerobic training; balance training

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

Study Arms (2)

Aerobic training (FIRST), then balance training (SECOND)

EXPERIMENTAL

Crossover trial: aerobic training (first treatment), then balance training (second treatment).

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).

Other: Aerobic training; Other: Balance training

Interventions

Aerobic training OTHER

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).

Aerobic training (FIRST), then balance training (SECOND); Balance training (FIRST), then aerobic training (SECOND)

Balance training OTHER

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.

Aerobic training (FIRST), then balance training (SECOND); Balance training (FIRST), then aerobic training (SECOND)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Related Publications (20)

• 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.

  PMID: 10871830 BACKGROUND

• 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.

  PMID: 25392337 BACKGROUND

• 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.

  PMID: 12474995 BACKGROUND

• Giesser BS. Exercise in the management of persons with multiple sclerosis. Ther Adv Neurol Disord. 2015 May;8(3):123-30. doi: 10.1177/1756285615576663.

  PMID: 25941539 BACKGROUND

• Giovannoni G. Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):2-3. doi: 10.1136/jnnp.2005.074948.

  PMID: 16361582 BACKGROUND

• Hebert 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.

  PMID: 23200463 BACKGROUND

• Hebert 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.

  PMID: 21680771 BACKGROUND

• Khan 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.

  PMID: 25309504 BACKGROUND

• Kos 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.

  PMID: 15732270 BACKGROUND

• Kurtzke 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.

  PMID: 6685237 BACKGROUND

• Larson 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.

  PMID: 24453758 BACKGROUND

• Mayo 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.

  PMID: 23809312 BACKGROUND

• Mills 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.

  PMID: 21135018 BACKGROUND

• Mostert 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.

  PMID: 11990874 BACKGROUND

• Rampello 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.

  PMID: 17405806 BACKGROUND

• Rota V, Perucca L, Simone A, Tesio L. Walk ratio (step length/cadence) as a summary index of neuromotor control of gait: application to multiple sclerosis. Int J Rehabil Res. 2011 Sep;34(3):265-9. doi: 10.1097/MRR.0b013e328347be02.

  PMID: 21629125 BACKGROUND

• Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.

  PMID: 15824337 BACKGROUND

• Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

  PMID: 21205966 BACKGROUND

• Tesio L, Perucca L, Franchignoni FP, Battaglia MA. A short measure of balance in multiple sclerosis: validation through Rasch analysis. Funct Neurol. 1997 Sep-Oct;12(5):255-65.

  PMID: 9439943 BACKGROUND

• Tesio L, Rota V, Longo S, Grzeda MT. Measuring standing balance in adults: reliability and minimal real difference of 14 instrumental measures. Int J Rehabil Res. 2013 Dec;36(4):362-74. doi: 10.1097/MRR.0000000000000037.

  PMID: 24185405 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Perucca, MD

  Istituto Auxologico Italiano

  STUDY CHAIR

• Antonio Caronni, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

• Stefano Scarano, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

• Antonio Robecchi Majnardi, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

• Giovanna Russo, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: September 22, 2023
• Study Start: February 17, 2016
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 22, 2023

Record last verified: 2023-09