Sport Therapy and Osteopathy Manipulative Treatment in ALS (ME_E_SLA)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sport therapy
Osteopathic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, sport therapy, osteopathic manual treatment, muscle oxidative metabolism
Eligibility Criteria
Inclusion Criteria:
- diagnosis of ALS
- early stages of disease
- able to perform exercise with major muscle groups.
Exclusion Criteria:
- non-invasive ventilation (NIV)
- tracheostomy
- coronaropathy
- ongoing infectious diseases
- cognitive deficits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
active; sport therapy
passive; osteopathic treatment
Arm Description
active exercise carefully calibrated on residual capacities.
manipulative treatment according to osteopathic principles.
Outcomes
Primary Outcome Measures
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)
appearance of side effects during the period of intervention administration
Secondary Outcome Measures
change of pain at 12 weeks
Brief Pain Inventory (BPI)
change of quality of life at 12 weeks
McGill Quality of Life
change of the neurological functional status at 12 weeks
ALS Functional Rating Scale-revised (ALSFRS-R)
Full Information
NCT ID
NCT02548663
First Posted
September 2, 2015
Last Updated
September 14, 2015
Sponsor
University of Milano Bicocca
Collaborators
Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02548663
Brief Title
Sport Therapy and Osteopathy Manipulative Treatment in ALS
Acronym
ME_E_SLA
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Milano Bicocca
Collaborators
Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
amyotrophic lateral sclerosis, sport therapy, osteopathic manual treatment, muscle oxidative metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active; sport therapy
Arm Type
Experimental
Arm Description
active exercise carefully calibrated on residual capacities.
Arm Title
passive; osteopathic treatment
Arm Type
Experimental
Arm Description
manipulative treatment according to osteopathic principles.
Intervention Type
Other
Intervention Name(s)
Sport therapy
Intervention Description
Frequency: 60 min three times/week
20 min: aerobic training on bicycle ergometer.
20 min: strength training at 60% of maximal load.
20 min: proprioception and stretching exercises.
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment
Intervention Description
Frequency: 60 min weekly
Primary Outcome Measure Information:
Title
change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks
Description
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)
Time Frame
12 weeks
Title
appearance of side effects during the period of intervention administration
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change of pain at 12 weeks
Description
Brief Pain Inventory (BPI)
Time Frame
12 weeks
Title
change of quality of life at 12 weeks
Description
McGill Quality of Life
Time Frame
12 weeks
Title
change of the neurological functional status at 12 weeks
Description
ALS Functional Rating Scale-revised (ALSFRS-R)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of ALS
early stages of disease
able to perform exercise with major muscle groups.
Exclusion Criteria:
non-invasive ventilation (NIV)
tracheostomy
coronaropathy
ongoing infectious diseases
cognitive deficits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Lanfranconi, MD
Organizational Affiliation
University of Milano Bicocca
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
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Citation
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Sport Therapy and Osteopathy Manipulative Treatment in ALS
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