Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— ENDURANCE  

Official title:

Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650818
• Other study ID #: CEC641
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2012
• Last updated: September 8, 2013
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2013
• Source: Fondazione Salvatore Maugeri
• Contact: Fabrizio Pisano, MD
• Phone: +39-0322-884723
• Email: fabrizio.pisano[@]fsm.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno	Veruno

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Mezzani A, Pisano F, Cavalli A, Tommasi MA, Corrà 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in peak oxygen consumption (peak VO2)	Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing	3 months	No
Secondary	Aerobic training safety and tolerability	Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program	3 months	Yes
Secondary	Change from baseline in quality of life	Evaluate the effects of aerobic training on quality of life, as assessed by McGill questionary	3 months	No
Secondary	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	3 months	No
Secondary	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	3 months	No
Secondary	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	3 months	No
Secondary	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	3 months	No
Secondary	Change from baseline in circulating inflammatory markers, growth factors and descriptors of skeletal muscle damage	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)	3 months	No