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Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS) (ALS-project)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504009
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : June 14, 2016
Odense University Hospital
Information provided by (Responsible Party):
Line Jensen, University of Southern Denmark

Brief Summary:

Patients with neuropathic diseases are experiencing increasing muscle weakness, loss of muscle strength and functional abilities during their illness. In healthy people, regular exercise is the best way to maintain or improve muscle strength, endurance and general health status and thereby maintain functioning abilities. Previously, patients with neuromuscular diseases were advised to avoid any kind of physical exercise. However, lately a number of studies have evaluated the effect of training in patients with neuromuscular diseases, and positive effects on the functional abilities have been found. Based on these findings we want to investigate the mechanisms leading to development of muscle atrophy and loss of functional abilities, and to explore the opportunities of reducing muscle wasting and thereby improve the course of the disease development through strength training.

The main objective is to investigate the effects of strength training on slowing disease progression and reduce the decline in muscle strength and function in patients with amyotrophic lateral sclerosis (ALS). In addition, the aim is to carry out detailed studies of biological processes in muscle tissue in order to unveil mechanisms leading to muscle atrophy, and to examine effects of a strength training program. The goal is to be able to incorporate strength training in the treatment program of these patients in order to maintain muscle strength and function in the individual for as long as possible.

Minimum 10 patients with the disease are included in the study. Through a 12 week period the patients will participate in strength training 2-3 times per week. Muscles biopsies will be taken (i) 12 weeks before commencement of strength training program, (ii) at the beginning of training and (iii) after 12 weeks of strength training. Patients will function as their own controls. Blood samples will be collected simultaneously in order to follow the development of the strength training. Furthermore, participants will be assessed through at number of functional tests and questionnaires evaluating their strength, balance and social/ psychological status.

Subjects are recruited through their association with Odense University Hospital. In the present study, the participants become part of a social network, while participating in organized training sessions, and thus have a possibility to make contact with other ALS patients in the same situation as themselves.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Muscle Training in Patients With Amyotrophic Lateral Sclerosis and Looking Into the Mechanisms Behind Development of Muscle Atrophy
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Muscle strength Other: Muscle training
12 weeks of strength training 2-3 times/week
Other Names:
  • Strength training
  • Rehabilitation

Primary Outcome Measures :
  1. Improved muscle strength [ Time Frame: 12 weeks ]
    Measured by Power Rig, KinCom (RFD, Interpolated twich), Calf Press exercises as well as Sway analysis and functional assesments (Timed-up-go + chair rise) Immunohistochemical, genearray, ELISA and Western Blotting analysis techniques are used to gain further data/insight.

Secondary Outcome Measures :
  1. Physical, social and mental quality of life [ Time Frame: 24 month ]
    SF-36, Barthel-20, ALSFRS-r and own designed questionaire (physical activity).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with Amyotrophic lateral sclerosis (ALS)

Exclusion Criteria:

  • Late stage ALS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01504009

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Department of Clinical Research, Odense University Hospital, University of Southern Denmark
Odense C, Fyn, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
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Principal Investigator: Henrik D Schroeder, MD Odense University Hospital

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Responsible Party: Line Jensen, PhD-student, University of Southern Denmark Identifier: NCT01504009    
Other Study ID Numbers: ALS-2011.05
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data has been and will be published. Individual participant data may not be available.
Keywords provided by Line Jensen, University of Southern Denmark:
Nervous System Disease
Neurodegenerative Disease
Motor Neuron Disease
Muscle training
Muscle atrophy
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases