Clinical trial NCT01650818: Aerobic Exercise Training in Amyotrophic Lateral Sclerosis
Official title: Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
Aerobic training
Peak oxygen consumption
Quality of life
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in peak oxygen consumption (peak VO2)
timeFrame: 3 months
Secondary outcomes:
measure: Aerobic training safety and tolerability
timeFrame: 3 months
measure: Change from baseline in quality of life
timeFrame: 3 months
measure: Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score
timeFrame: 3 months
measure: Change from baseline in lower limbs muscle strength
timeFrame: 3 months
measure: Change from baseline in upper and lower motor neurons function at the upper and lower limbs level
timeFrame: 3 months
measure: Change from baseline in ventilatory function
timeFrame: 3 months
measure: Change from baseline in circulating inflammatory markers, growth factors and descriptors of skeletal muscle damage
timeFrame: 3 months
Other outcomes:
Locations:
city: Veruno
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Study officials:
affiliation: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
name: Alessandro Mezzani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
name: Fabrizio Pisano, MD
role: STUDY_DIRECTOR
References:
citation: Mezzani A, Pisano F, Cavalli A, Tommasi MA, Corra U, Colombo S, Grassi B, Marzorati M, Porcelli S, Morandi L, Giannuzzi P. Reduced exercise capacity in early-stage amyotrophic lateral sclerosis: Role of skeletal muscle. Amyotroph Lateral Scler. 2012 Jan;13(1):87-94. doi: 10.3109/17482968.2011.601463. Epub 2011 Aug 11.