Amyotrophic Lateral SclerosisENDURANCENCT01650818
Aerobic Exercise Training in Amyotrophic Lateral Sclerosis
A study testing Aerobic exercise training and Standard physical therapy (Stretching/Range-of-motion) in people with Amyotrophic Lateral Sclerosis, run by Fondazione Salvatore Maugeri at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Aerobic exercise training and Standard physical therapy (Stretching/Range-of-motion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Veruno, 28010
Alessandro Mezzani, MD, FESC, 3403119299, alessandro.mezzani@fsm.it
Alessandro Mezzani, MD, FESC
About this study
Official title: Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention
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).
Read the 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
- Being tested
- Aerobic exercise training, Standard physical therapy (Stretching/Range-of-motion)
- Keywords
- Amyotrophic lateral sclerosis, Aerobic training, Peak oxygen consumption, Quality of life
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
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)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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training | Experimental | Not described Receives: Other: Aerobic exercise training |
| Standard physical therapy | Active comparator | Not described Receives: Other: Standard physical therapy (Stretching/Range-of-motion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in peak oxygen consumption (peak VO2)
Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing
Measured: 3 months
Secondary outcomes (7)
Aerobic training safety and tolerability
Evaluate aerobic training safety and tolerability in terms of adverse events incidence and adherence to training program
Measured: 3 months
Change from baseline in quality of life
Evaluate the effects of aerobic training on quality of life, as assessed by McGill questionary
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Mezzani, Fondazione Salvatore Maugeri
- Investigators
- Alessandro Mezzani, MD, Principal investigator, Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of VerunoFabrizio Pisano, MD, Study director, Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650818
- Sponsor's protocol ID
- CEC641
- Acronym
- ENDURANCE
- Status last verified
- Sep 2013
- First submitted
- 24 Jul 2012
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21830991
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise traiNing in Amyotrophic Lateral Sclerosis: a ranDomized Trial Comparing Home-based Aerobic endUrance tRAiNing vs. Usual physiCal Therapy intErvention
- ClinicalTrials.gov ID
- NCT01650818
- Acronym / sponsor ID
- ENDURANCE / CEC641
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, Aerobic training, Peak oxygen consumption, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training | Experimental | Other: Aerobic exercise training |
| Standard physical therapy | Active comparator | Other: Standard physical therapy (Stretching/Range-of-motion) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingIntensity: 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 | Other | Aerobic exercise training |
| 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 | Other | Standard physical therapy |
Primary outcome
Change from baseline in peak oxygen consumption (peak VO2)
Time frame: 3 months
Evaluate the effects of aerobic training on peak VO2, as assessed by cardiopulmonary exercise testing
7 secondary outcomes
Aerobic training safety and tolerability
Time frame: 3 months
Change from baseline in quality of life
Time frame: 3 months
Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score
Time frame: 3 months
Change from baseline in lower limbs muscle strength
Time frame: 3 months
Change from baseline in upper and lower motor neurons function at the upper and lower limbs level
Time frame: 3 months
Change from baseline in ventilatory function
Time frame: 3 months
Change from baseline in circulating inflammatory markers, growth factors and descriptors of skeletal muscle damage
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Background: PubMed 21830991Mezzani 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Mezzani, MD principal investigator
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Fabrizio Pisano, MD study director
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training and Standard physical therapy (Stretching/Range-of-motion) in people with Amyotrophic Lateral Sclerosis, run by Fondazione Salvatore Maugeri at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Pisano, MD (+39-0322-884723, fabrizio.pisano@fsm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in peak oxygen consumption (peak VO2) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013; AzTrials last refreshed its copy on 31 Oct 2026.