Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

— ALS-project  

Official title:

Investigating the Effect of Muscle Training in Patients With Amyotrophic Lateral Sclerosis and Looking Into the Mechanisms Behind Development of Muscle Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504009
• Other study ID #: ALS-2011.05
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: June 13, 2016
• Start date: May 2011
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with Amyotrophic lateral sclerosis (ALS)

Exclusion Criteria:

• Late stage ALS

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Muscle training
12 weeks of strength training 2-3 times/week

Locations

Country	Name	City	State
Denmark	Department of Clinical Research, Odense University Hospital, University of Southern Denmark	Odense C	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved muscle strength	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.	12 weeks	No
Secondary	Physical, social and mental quality of life	SF-36, Barthel-20, ALSFRS-r and own designed questionaire (physical activity).	24 month	No