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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Line Jensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01504009
First received: January 2, 2012
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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 Intervention
Amyotrophic Lateral Sclerosis
Other: Muscle training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Improved muscle strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Physical, social and mental quality of life [ Time Frame: 24 month ] [ Designated as safety issue: No ]
    SF-36, Barthel-20, ALSFRS-r and own designed questionaire (physical activity).


Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Muscle strength Other: Muscle training
12 weeks of strength training 2-3 times/week
Other Names:
  • Strength training
  • Rehabilitation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Amyotrophic lateral sclerosis (ALS)

Exclusion Criteria:

  • Late stage ALS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504009

Locations
Denmark
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
Investigators
Principal Investigator: Henrik D Schroeder, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Line Jensen, PhD-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01504009     History of Changes
Other Study ID Numbers: ALS-2011.05
Study First Received: January 2, 2012
Last Updated: January 4, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Nervous System Disease
Neurodegenerative Disease
Motor Neuron Disease
ALS
Muscle training
Muscle atrophy

Additional relevant MeSH terms:
Sclerosis
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

ClinicalTrials.gov processed this record on September 18, 2014