Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

Fondazione Salvatore Maugeri40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Aerobic exercise trainingOTHER

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

Standard physical therapy (Stretching/Range-of-motion)OTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Veruno, Italy

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in peak oxygen consumption (peak VO2)

Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing

Time frame: 3 months

Secondary Outcomes

Aerobic training safety and tolerability

Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program

Time frame: 3 months

Change from baseline in quality of life

Evaluate the effects of aerobic training on quality of life, as assessed by McGill questionary

Time frame: 3 months

Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score

Evaluate the effects of aerobic training on the ALSFRS-R score

Time frame: 3 months

Change from baseline in lower limbs muscle strength

Evaluate the effects of aerobic training on isometric muscle strength of lower limbs, as assessed by isometric dynamometry

Time frame: 3 months

Change from baseline in upper and lower motor neurons function at the upper and lower limbs level

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

Time frame: 3 months

Change from baseline in ventilatory function

Evaluate the effects of aerobic training on ventilatory function, as assessed by spirometry and measurement of maximal inspiratory and expiratory pressures

Central Contacts

Fabrizio Pisano, MD

CONTACT

+39-0322-884723 fabrizio.pisano@fsm.it

Data from ClinicalTrials.gov

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