Aerobic Exercise Training in Amyotrophic Lateral Sclerosis (ENDURANCE)

This study is currently recruiting participants.
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

July 24, 2012
September 8, 2013
January 2012
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01650818 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Aerobic Exercise Training in Amyotrophic Lateral Sclerosis
Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Amyotrophic Lateral Sclerosis
  • 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
  • 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
  • Experimental: Aerobic exercise training
    Intervention: Other: Aerobic exercise training
  • Active Comparator: Standard physical therapy
    Intervention: Other: Standard physical therapy (Stretching/Range-of-motion)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Fabrizio Pisano, MD +39-0322-884723 fabrizio.pisano@fsm.it
Italy
 
NCT01650818
CEC641
Yes
Alessandro Mezzani, Fondazione Salvatore Maugeri
Fondazione Salvatore Maugeri
Not Provided
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
Fondazione Salvatore Maugeri
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP