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Amyotrophic Lateral SclerosisPhase 1/2NCT00160004

The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

A Phase 1/2 study of Amyotrophic Lateral Sclerosis, run by Radboud University Medical Center at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are usually supported by a multidisciplinary team. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyotrophic Lateral Sclerosis
How many people
20 participants
Where
1 siteNetherlands
Study dates
Mar 2006to Dec 2008
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older dan 18 years Written Informed Consent Don't use walking adds such as a cane Patients must met El Escorial criteria for probable or definite ALS

Who cannot join

  • Patients who are depending on intermittent or continuous mechanical ventilation Patients who are not able to understand and conform to the instructions Patients who already perform an exercise programme that can compare with our study Patients who have severe cardiopulmonary problems, DM or other problems concerning connective tissue.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Department of Allied health Occupations, Radboud University Nijmegen Medical Centre

    Nijmegen, Gelderland, 6500 HB

Other trials in Netherlands

About this study

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are usually supported by a multidisciplinary team. One of the members of this team is the physical therapist. The aim of physical therapy might be to enhance or to preserve cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to high intensive exercise programme might lead to overuse weakness (an undesired fast progression of muscle weakness). The primary objective of this study is therefore to investigate whether regular moderate to high intensity exercise program in ALS can maintain or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to investigate whether such a programme leads to overuse weakness and if there is a positive influence on patient's disability, fatigue and quality of life.

Being tested
Intensive Controlled Exercise
Keywords
Amyotrophic Lateral Sclerosis, Exercise, Fatigue, Quality-of-life
Medical subject headings
Amyotrophic Lateral Sclerosis, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Controlled ExerciseBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory fitness measured with Astrand submaximal test

Secondary outcomes (5)

  1. Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)

  2. Functional status measured with ALS-FRS-r Rating scale

  3. Quality of life with ALS-AQ40 Questionnaire

  4. Fatigue measured with CIS Questionnaire

  5. Pulmonary function measured with FVC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startMar 2006
  3. Study completionDec 2008

Why it stopped: problems with including patients and a large multicenter Trial is now starting as follow-up

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160004
Sponsor's protocol ID
ALSICEJ1
Status last verified
Jun 2009
First submitted
9 Sep 2005
Last updated
8 Jun 2009
Results posted
No

Publications

  • Drory VE, Goltsman E, Reznik JG, Mosek A, Korczyn AD. The value of muscle exercise in patients with amyotrophic lateral sclerosis. J Neurol Sci. 2001 Oct 15;191(1-2):133-7. doi: 10.1016/s0022-510x(01)00610-4.

    PubMed 11677004

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Amyotrophic Lateral Sclerosis, run by Radboud University Medical Center at 1 site in Netherlands.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Jun 2009. 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 Netherlands. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: problems with including patients and a large multicenter Trial is now starting as follow-up). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory fitness measured with Astrand submaximal test. 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 NCT00160004, 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 8 Jun 2009; AzTrials last refreshed its copy on 6 Nov 2026.

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