Sport Therapy and Osteopathy Manipulative Treatment in ALS
NCT ID: NCT02548663
Last Updated: 2015-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2014-06-30
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Video-Based Proprioceptive Exercise Program in ALS
NCT07292545
Effect of Functional Exercise in Patients With Spinal Bulbar Muscular Atrophy
NCT01369901
Study of the Effects Strengthening Exercises in Individuals With ALS
NCT00204464
Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis
NCT05309447
Photobiomodulation Therapy Treatment on Facial Paralysis
NCT05585333
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
active; sport therapy
active exercise carefully calibrated on residual capacities.
Sport therapy
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.
passive; osteopathic treatment
manipulative treatment according to osteopathic principles.
Osteopathic treatment
Frequency: 60 min weekly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sport therapy
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.
Osteopathic treatment
Frequency: 60 min weekly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* early stages of disease
* able to perform exercise with major muscle groups.
Exclusion Criteria
* tracheostomy
* coronaropathy
* ongoing infectious diseases
* cognitive deficits.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy
UNKNOWN
University of Milano Bicocca
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesca Lanfranconi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Milano Bicocca
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ME_E_SLA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.