Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Aerobic exercise training; Other: Standard physical therapy (Stretching/Range-of-motion)

• Registration Number: NCT01650818
• Lead Sponsor: Fondazione Salvatore Maugeri

Brief Summary

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).

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-08
• Last Update Posted: 2013-09-10
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise training	Aerobic exercise training	-
Standard physical therapy	Standard physical therapy (Stretching/Range-of-motion)	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in peak oxygen consumption (peak VO2)	3 months	Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing

Secondary Outcome Measures

Name	Time	Method
Aerobic training safety and tolerability	3 months	Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program
Change from baseline in quality of life	3 months	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	3 months	Evaluate the effects of aerobic training on the ALSFRS-R score
Change from baseline in lower limbs muscle strength	3 months	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	3 months	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	3 months	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	3 months	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)

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno; 🇮🇹 Veruno, Italy