Amyotrophic Lateral Sclerosis
Conditions
Keywords
Amyotrophic lateral sclerosis, Aerobic training, Peak oxygen consumption, Quality of life
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.
Interventions
OTHERAerobic 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
OTHERStandard 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
Sponsors
Fondazione Salvatore Maugeri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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) |
| 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 |
Countries
Italy
Contacts
Primary ContactFabrizio Pisano, MD
Outcome results
None listed