Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

NCT01650818 | Unknown DMC

• 1 other identifier: CEC641
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Aerobic training safety and tolerability

  3 months

• Change from baseline in quality of life

  3 months

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

  3 months

• Change from baseline in lower limbs muscle strength

  3 months

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

  3 months

Study Arms (2)

Aerobic exercise training

EXPERIMENTAL

Other: Aerobic exercise training

Standard physical therapy

ACTIVE COMPARATOR

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

Interventions

Aerobic exercise training 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

Aerobic exercise training

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

Standard physical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

Veruno, 28010, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 21830991 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alessandro Mezzani, MD

  Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

  PRINCIPAL INVESTIGATOR

• Fabrizio Pisano, MD

  Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno

  STUDY DIRECTOR

Central Study Contacts

Fabrizio Pisano, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FESC

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

IT (1)