Sport Therapy and Osteopathy Manipulative Treatment in ALS (ME_E_SLA)

September 14, 2015 updated by: University of Milano Bicocca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active; sport therapy
active exercise carefully calibrated on residual capacities.
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.
Experimental: passive; osteopathic treatment
manipulative treatment according to osteopathic principles.
Other: Osteopathic treatment
Frequency: 60 min weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks
appearance of side effects during the period of intervention administration
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of pain at 12 weeks
Time Frame: 12 weeks
Brief Pain Inventory (BPI)
12 weeks
change of quality of life at 12 weeks
Time Frame: 12 weeks
McGill Quality of Life
12 weeks
change of the neurological functional status at 12 weeks
Time Frame: 12 weeks
ALS Functional Rating Scale-revised (ALSFRS-R)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Collaborators

Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy

Investigators

  • Principal Investigator: Francesca Lanfranconi, MD, University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME_E_SLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Clinical Trials on Sport therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe