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Aerobic Exercise Training in Amyotrophic Lateral Sclerosis (ENDURANCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Fondazione Salvatore Maugeri
Sponsor:
Information provided by (Responsible Party):
Alessandro Mezzani, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT01650818
First received: July 24, 2012
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to compare the safety and the effects of moderate-intensity aerobic endurance training to those of an usual physical therapy intervention on exercise capacity and quality of life in patients with amyotrophic lateral sclerosis (ALS).


Condition Intervention
Amyotrophic Lateral Sclerosis
Other: Aerobic exercise training
Other: Standard physical therapy (Stretching/Range-of-motion)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • Change from baseline in peak oxygen consumption (peak VO2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing


Secondary Outcome Measures:
  • Aerobic training safety and tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program

  • Change from baseline in quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on quality of life, as assessed by McGill questionary

  • Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on the ALSFRS-R score

  • Change from baseline in lower limbs muscle strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on isometric muscle strength of lower limbs, as assessed by isometric dynamometry

  • Change from baseline in upper and lower motor neurons function at the upper and lower limbs level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on upper and lower motor neurons function at the upper and lower limbs level, as determined by compound muscle action potential and neurophysiological index and motor evoked potentials

  • Change from baseline in ventilatory function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on ventilatory function, as assessed by spirometry and measurement of maximal inspiratory and expiratory pressures

  • Change from baseline in circulating inflammatory markers, growth factors and descriptors of skeletal muscle damage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Evaluate the effects of aerobic training on circulating inflammatory markers and growth factors (CRP, TNF-alfa, IL-6, Angiogenin, Angiopoietin 1 and 2, Thrombospondin, VEGF, BDNF, IGF-1) and markers of skeletal muscle damage (CPK)


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic exercise training Other: Aerobic exercise training
Intensity: heart rate corresponding to 40% peak VO2. Frequency: 5 sessions/week. Duration: 5 min warm-up + 20 min training + 5 min cool-down during the 1st month; 5 min warm-up + 30 min training + 5 min cool-down during the 2nd and 3rd month
Active Comparator: Standard physical therapy Other: Standard physical therapy (Stretching/Range-of-motion)
Intensity: N/A. Frequency: 5 sessions/week. Duration: 5 min warm-up + 20 min training + 5 min cool-down during the 1st month; 5 min warm-up + 30 min training + 5 min cool-down during the 2nd and 3rd month

Detailed Description:

Scarce evidence is available regarding aerobic exercise training of patients with ALS. Some studies using transgenic mouse models of familial ALS have shown markedly slowed disease progression, improved functional capacity, and extension of survival in animals undergoing aerobic exercise training. In humans, only one non-randomized study has shown that moderate-intensity aerobic exercise training was of little beneficial effect in a small group of patients with Kennedy disease, a rare X-linked progressive neuromuscular disease involving lower motorneurons, presenting a pathophysiological picture quite different from that of ALS. To the best of our knowledge, the safety and the effects of aerobic exercise training on functional capacity and quality of life of patients with ALS have not been systematically evaluated as yet in a randomized, controlled trial with an adequate sample size.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of definite ALS, probable ALS, or probable-laboratory supported ALS according to the El Escorial criteria or diagnosis of progressive muscular atrophy.
  • Ability to perform a baseline symptom-limited cardiopulmonary exercise test with attainment of peak power and respiratory exchange ratio of >= 50 W and >= 1.00, respectively.
  • Time since symptoms onset <= 18 months.
  • Forced vital capacity >= 70% of predicted.
  • Informed written consent.

Exclusion Criteria:

  • Coexisting neurological disease.
  • Coexisting extra-neurological disease significantly affecting exercise capacity.
  • Coexisting malignancy.
  • Ongoing/planned pregnancy.
  • Involvement in formal endurance and/or strength training program.
  • Enrolment in any other clinical trial.
  • Cognitive impairment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650818

Contacts
Contact: Fabrizio Pisano, MD +39-0322-884723 fabrizio.pisano@fsm.it

Locations
Italy
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno Recruiting
Veruno, Italy, 28010
Contact: Alessandro Mezzani, MD, FESC    3403119299    alessandro.mezzani@fsm.it   
Principal Investigator: Alessandro Mezzani, MD, FESC         
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Alessandro Mezzani, MD Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Study Director: Fabrizio Pisano, MD Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
  More Information

No publications provided

Responsible Party: Alessandro Mezzani, MD, FESC, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT01650818     History of Changes
Other Study ID Numbers: CEC641
Study First Received: July 24, 2012
Last Updated: September 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
Amyotrophic lateral sclerosis
Aerobic training
Peak oxygen consumption
Quality of life

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on November 25, 2014