Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

NCT ID: NCT01650818

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis; Aerobic training; Peak oxygen consumption; Quality of life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Aerobic exercise training

Group Type: EXPERIMENTAL

Aerobic exercise training

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Mezzani

MD, FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Mezzani, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Fabrizio Pisano, MD

Role: STUDY_DIRECTOR

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Locations

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Veruno, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabrizio Pisano, MD

Role: CONTACT

Phone: +39-0322-884723

Email: fabrizio.pisano@fsm.it

Facility Contacts

Alessandro Mezzani, MD, FESC

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 21830991 (View on PubMed)

Other Identifiers

CEC641

Identifier Type: -

Identifier Source: org_study_id