Clinical trial NCT01504009: Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Nervous System Disease
Neurodegenerative Disease
Motor Neuron Disease
ALS
Muscle training
Muscle atrophy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2012-01-04
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Amyotrophic lateral sclerosis (ALS)

Exclusion Criteria:

* Late stage ALS

Primary outcomes:
measure: Improved muscle strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical, social and mental quality of life
timeFrame: 24 month
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Clinical Research, Odense University Hospital, University of Southern Denmark
state: Fyn
Study officials:
affiliation: Odense University Hospital
name: Henrik D Schroeder, MD
role: PRINCIPAL_INVESTIGATOR
References: