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Aerobic Exercise Training in Amyotrophic Lateral Sclerosis (ENDURANCE)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aerobic exercise training
Standard physical therapy (Stretching/Range-of-motion)
Sponsored by
Fondazione Salvatore Maugeri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis, Aerobic training, Peak oxygen consumption, Quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of VerunoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercise training

Standard physical therapy

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in peak oxygen consumption (peak VO2)
Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing

Secondary Outcome Measures

Aerobic training safety and tolerability
Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program
Change from baseline in quality of life
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
Evaluate the effects of aerobic training on the ALSFRS-R score
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
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
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
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)

Full Information

First Posted
July 24, 2012
Last Updated
September 8, 2013
Sponsor
Fondazione Salvatore Maugeri
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1. Study Identification

Unique Protocol Identification Number
NCT01650818
Brief Title
Aerobic Exercise Training in Amyotrophic Lateral Sclerosis
Acronym
ENDURANCE
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic lateral sclerosis, Aerobic training, Peak oxygen consumption, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise training
Arm Type
Experimental
Arm Title
Standard physical therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Aerobic exercise training
Intervention Description
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
Intervention Name(s)
Standard physical therapy (Stretching/Range-of-motion)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in peak oxygen consumption (peak VO2)
Description
Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Aerobic training safety and tolerability
Description
Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program
Time Frame
3 months
Title
Change from baseline in quality of life
Description
Evaluate the effects of aerobic training on quality of life, as assessed by McGill questionary
Time Frame
3 months
Title
Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score
Description
Evaluate the effects of aerobic training on the ALSFRS-R score
Time Frame
3 months
Title
Change from baseline in lower limbs muscle strength
Description
Evaluate the effects of aerobic training on isometric muscle strength of lower limbs, as assessed by isometric dynamometry
Time Frame
3 months
Title
Change from baseline in upper and lower motor neurons function at the upper and lower limbs level
Description
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
Time Frame
3 months
Title
Change from baseline in ventilatory function
Description
Evaluate the effects of aerobic training on ventilatory function, as assessed by spirometry and measurement of maximal inspiratory and expiratory pressures
Time Frame
3 months
Title
Change from baseline in circulating inflammatory markers, growth factors and descriptors of skeletal muscle damage
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrizio Pisano, MD
Phone
+39-0322-884723
Email
fabrizio.pisano@fsm.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Mezzani, MD
Organizational Affiliation
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabrizio Pisano, MD
Organizational Affiliation
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
City
Veruno
ZIP/Postal Code
28010
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Mezzani, MD, FESC
Phone
3403119299
Email
alessandro.mezzani@fsm.it
First Name & Middle Initial & Last Name & Degree
Alessandro Mezzani, MD, FESC

12. IPD Sharing Statement

Citations:
PubMed Identifier
21830991
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.
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Aerobic Exercise Training in Amyotrophic Lateral Sclerosis

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