Sport Therapy and Osteopathy Manipulative Treatment in ALS (ME_E_SLA)
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|ClinicalTrials.gov Identifier: NCT02548663|
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : September 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Other: Sport therapy Other: Osteopathic treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Sport Therapy for Contrasting the Deterioration of Muscle Oxidative Metabolism in Patients Affected by Amyotrophic Lateral Sclerosis (ALS) - Project ME_E_SLA|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2015|
Experimental: active; sport therapy
active exercise carefully calibrated on residual capacities.
Other: Sport therapy
Frequency: 60 min three times/week
Experimental: passive; osteopathic treatment
manipulative treatment according to osteopathic principles.
Other: Osteopathic treatment
Frequency: 60 min weekly
- change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks [ Time Frame: 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)
- appearance of side effects during the period of intervention administration [ Time Frame: 12 weeks ]
- change of pain at 12 weeks [ Time Frame: 12 weeks ]Brief Pain Inventory (BPI)
- change of quality of life at 12 weeks [ Time Frame: 12 weeks ]McGill Quality of Life
- change of the neurological functional status at 12 weeks [ Time Frame: 12 weeks ]ALS Functional Rating Scale-revised (ALSFRS-R)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548663
|Principal Investigator:||Francesca Lanfranconi, MD||University of Milano Bicocca|