NCT02548663

Sport Therapy and Osteopathy Manipulative Treatment in ALS

Sport Therapy for Contrasting the Deterioration of Muscle Oxidative Metabolism in Patients Affected by Amyotrophic Lateral Sclerosis (ALS) - Project ME_E_SLA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
OTHER	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.
OTHER	Osteopathic treatment	Frequency: 60 min weekly

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2015-09-14
• Last updated: 2015-09-15