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OpenTrials
Completed

NCT Number: NCT01504009

Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS)

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Amyotrophic lateral sclerosis (ALS)

Exclusion criteria

  • Late stage ALS

Treatment and study plan

Muscle training

Other

12 weeks of strength training 2-3 times/week

Other names: Strength training, Rehabilitation

Primary outcomes

  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 outcomes

  1. Physical, social and mental quality of life

    Time frame: 24 month

    SF-36, Barthel-20, ALSFRS-r and own designed questionaire (physical activity).

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

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

Acronym: ALS-project

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Jan 4, 2012
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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