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| Name | Class |
|---|---|
| Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy | UNKNOWN |
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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.
Single blind pilot trial assessing the efficacy and side effects of active training or osteopathic manipulative treatment in ALS.
Interventions will be administered for three months (plus one month without intervention) by specialized personnel.
Primary outcome measures will include: exercise tolerance and muscle oxygen extraction capacity, side effects. Secondary outcome measures will include: pain, QoL and disease progression scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active; sport therapy | Experimental | active exercise carefully calibrated on residual capacities. |
|
| passive; osteopathic treatment | Experimental | manipulative treatment according to osteopathic principles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sport therapy | Other | Frequency: 60 min three times/week
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of pain at 12 weeks | Brief Pain Inventory (BPI) | 12 weeks |
| change of quality of life at 12 weeks | McGill Quality of Life | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesca Lanfranconi, MD | University of Milano Bicocca | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24367951 | Background | 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. | |
| 6856684 | 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. |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Osteopathic treatment | Other | Frequency: 60 min weekly |
|
| change of the neurological functional status at 12 weeks | ALS Functional Rating Scale-revised (ALSFRS-R) | 12 weeks |
| 8826494 | 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. |
| 23868282 | 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. |
| 19968977 | 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. |
| 21972798 | 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. |
| 10964037 | 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. |
| 23728653 | 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. |
| 17548549 | 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. |
| 19491245 | 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. |
| 11677004 | 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. |
| 12783429 | 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. |
| 15116368 | 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. |
| 10540010 | 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. |
| 14561497 | 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. |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012046 | Rehabilitation |