Sport Therapy and Osteopathy Manipulative Treatment in ALS

NCT02548663 | Completed

• 1 other identifier: ME_E_SLA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project assessed muscle oxidative metabolism and fatigue in patients affected by amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized cardiovascular and strength training. Muscle oxidative metabolism and strength will be assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit recruitment and related fatigue. The investigators will also assess the effects of training on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill Quality of Life questionnaires, using the validated Italian versions. Patients will be assessed longitudinally before (time T0) and after three months of individualized training (time T1). After one month of de-training (time T2) the investigators will assess the hypothetic persistence of any treatment-related effect. The effect of three months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis; sport therapy; osteopathic manual treatment; muscle oxidative metabolism

Outcome Measures

Primary Outcomes (2)

• change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks

  exercise tolerance assessed by Cardio pulmonary Exercise Test (CPET); oxygen extraction on vastus lateralis, respiratory muscle and hand thenar eminence muscles assessed by Near Infrared Spectroscopy (NIRS)

  12 weeks

• appearance of side effects during the period of intervention administration

  12 weeks

Secondary Outcomes (3)

• change of pain at 12 weeks

  12 weeks

• change of quality of life at 12 weeks

  12 weeks

• change of the neurological functional status at 12 weeks

  12 weeks

Study Arms (2)

active; sport therapy

EXPERIMENTAL

active exercise carefully calibrated on residual capacities.

Other: Sport therapy

passive; osteopathic treatment

EXPERIMENTAL

manipulative treatment according to osteopathic principles.

Other: Osteopathic treatment

Interventions

Sport therapy OTHER

Frequency: 60 min three times/week 1. 20 min: aerobic training on bicycle ergometer. 2. 20 min: strength training at 60% of maximal load. 3. 20 min: proprioception and stretching exercises.

active; sport therapy

Osteopathic treatment OTHER

Frequency: 60 min weekly

passive; osteopathic treatment

Eligibility Criteria

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

You may qualify if:

• diagnosis of ALS
• early stages of disease
• able to perform exercise with major muscle groups.

You may not qualify if:

• non-invasive ventilation (NIV)
• tracheostomy
• coronaropathy
• ongoing infectious diseases
• cognitive deficits.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy: collaborator

Related Publications (15)

• Arbesman M, Sheard K. Systematic review of the effectiveness of occupational therapy-related interventions for people with amyotrophic lateral sclerosis. Am J Occup Ther. 2014 Jan-Feb;68(1):20-6. doi: 10.5014/ajot.2014.008649.

  PMID: 24367951 BACKGROUND

• Bohannon RW. Results of resistance exercise on a patient with amyotrophic lateral sclerosis. A case report. Phys Ther. 1983 Jun;63(6):965-8. doi: 10.1093/ptj/63.6.965.

  PMID: 6856684 BACKGROUND

• Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5.

  PMID: 8826494 BACKGROUND

• Carilho R, de Carvalho M, Swash M, Pinto S, Pinto A, Costa J. Vascular endothelial growth factor and amyotrophic lateral sclerosis: the interplay with exercise and noninvasive ventilation. Muscle Nerve. 2014 Apr;49(4):545-50. doi: 10.1002/mus.23955.

  PMID: 23868282 BACKGROUND

• Carreras I, Yuruker S, Aytan N, Hossain L, Choi JK, Jenkins BG, Kowall NW, Dedeoglu A. Moderate exercise delays the motor performance decline in a transgenic model of ALS. Brain Res. 2010 Feb 8;1313:192-201. doi: 10.1016/j.brainres.2009.11.051. Epub 2009 Dec 5.

  PMID: 19968977 BACKGROUND

• Chio A, Canosa A, Gallo S, Moglia C, Ilardi A, Cammarosano S, Papurello D, Calvo A. Pain in amyotrophic lateral sclerosis: a population-based controlled study. Eur J Neurol. 2012 Apr;19(4):551-5. doi: 10.1111/j.1468-1331.2011.03540.x. Epub 2011 Oct 4.

  PMID: 21972798 BACKGROUND

• Colombo R, Mazzini L, Mora G, Parenzan R, Creola G, Pirali I, Minuco G. Measurement of isometric muscle strength: a reproducibility study of maximal voluntary contraction in normal subjects and amyotrophic lateral sclerosis patients. Med Eng Phys. 2000 Apr;22(3):167-74. doi: 10.1016/s1350-4533(00)00024-2.

  PMID: 10964037 BACKGROUND

• Dal Bello-Haas V, Florence JM. Therapeutic exercise for people with amyotrophic lateral sclerosis or motor neuron disease. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD005229. doi: 10.1002/14651858.CD005229.pub3.

  PMID: 23728653 BACKGROUND

• Bello-Haas VD, Florence JM, Kloos AD, Scheirbecker J, Lopate G, Hayes SM, Pioro EP, Mitsumoto H. A randomized controlled trial of resistance exercise in individuals with ALS. Neurology. 2007 Jun 5;68(23):2003-7. doi: 10.1212/01.wnl.0000264418.92308.a4.

  PMID: 17548549 BACKGROUND

• Deforges S, Branchu J, Biondi O, Grondard C, Pariset C, Lecolle S, Lopes P, Vidal PP, Chanoine C, Charbonnier F. Motoneuron survival is promoted by specific exercise in a mouse model of amyotrophic lateral sclerosis. J Physiol. 2009 Jul 15;587(Pt 14):3561-72. doi: 10.1113/jphysiol.2009.169748. Epub 2009 Jun 2.

  PMID: 19491245 BACKGROUND

• Drory VE, Goltsman E, Reznik JG, Mosek A, Korczyn AD. The value of muscle exercise in patients with amyotrophic lateral sclerosis. J Neurol Sci. 2001 Oct 15;191(1-2):133-7. doi: 10.1016/s0022-510x(01)00610-4.

  PMID: 11677004 BACKGROUND

• Kirkinezos IG, Hernandez D, Bradley WG, Moraes CT. Regular exercise is beneficial to a mouse model of amyotrophic lateral sclerosis. Ann Neurol. 2003 Jun;53(6):804-7. doi: 10.1002/ana.10597.

  PMID: 12783429 BACKGROUND

• Mahoney DJ, Rodriguez C, Devries M, Yasuda N, Tarnopolsky MA. Effects of high-intensity endurance exercise training in the G93A mouse model of amyotrophic lateral sclerosis. Muscle Nerve. 2004 May;29(5):656-62. doi: 10.1002/mus.20004.

  PMID: 15116368 BACKGROUND

• Pinto AC, Alves M, Nogueira A, Evangelista T, Carvalho J, Coelho A, de Carvalho M, Sales-Luis ML. Can amyotrophic lateral sclerosis patients with respiratory insufficiency exercise? J Neurol Sci. 1999 Oct 31;169(1-2):69-75. doi: 10.1016/s0022-510x(99)00218-x.

  PMID: 10540010 BACKGROUND

• Veldink JH, Bar PR, Joosten EA, Otten M, Wokke JH, van den Berg LH. Sexual differences in onset of disease and response to exercise in a transgenic model of ALS. Neuromuscul Disord. 2003 Nov;13(9):737-43. doi: 10.1016/s0960-8966(03)00104-4.

  PMID: 14561497 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Francesca Lanfranconi, MD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 14, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09