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The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Terminated
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Intensive Controlled Exercise
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Exercise, Fatigue, Quality-of-life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Older dan 18 years Written Informed Consent Don't use walking adds such as a cane Patients must met El Escorial criteria for probable or definite ALS Exclusion Criteria: Patients who are depending on intermittent or continuous mechanical ventilation Patients who are not able to understand and conform to the instructions Patients who already perform an exercise programme that can compare with our study Patients who have severe cardiopulmonary problems, DM or other problems concerning connective tissue.

Sites / Locations

  • Department of Allied health Occupations, Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness measured with Astrand submaximal test

Secondary Outcome Measures

Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
Functional status measured with ALS-FRS-r Rating scale
Quality of life with ALS-AQ40 Questionnaire
Fatigue measured with CIS Questionnaire
Pulmonary function measured with FVC

Full Information

First Posted
September 9, 2005
Last Updated
June 5, 2009
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00160004
Brief Title
The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
Official Title
The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
problems with including patients and a large multicenter Trial is now starting as follow-up
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

Brief Summary
Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are usually supported by a multidisciplinary team. One of the members of this team is the physical therapist. The aim of physical therapy might be to enhance or to preserve cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to high intensive exercise programme might lead to overuse weakness (an undesired fast progression of muscle weakness). The primary objective of this study is therefore to investigate whether regular moderate to high intensity exercise program in ALS can maintain or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to investigate whether such a programme leads to overuse weakness and if there is a positive influence on patient's disability, fatigue and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Exercise, Fatigue, Quality-of-life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Intensive Controlled Exercise
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness measured with Astrand submaximal test
Secondary Outcome Measure Information:
Title
Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
Title
Functional status measured with ALS-FRS-r Rating scale
Title
Quality of life with ALS-AQ40 Questionnaire
Title
Fatigue measured with CIS Questionnaire
Title
Pulmonary function measured with FVC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older dan 18 years Written Informed Consent Don't use walking adds such as a cane Patients must met El Escorial criteria for probable or definite ALS Exclusion Criteria: Patients who are depending on intermittent or continuous mechanical ventilation Patients who are not able to understand and conform to the instructions Patients who already perform an exercise programme that can compare with our study Patients who have severe cardiopulmonary problems, DM or other problems concerning connective tissue.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, PhD
Organizational Affiliation
Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Allied health Occupations, Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
11677004
Citation
Drory VE, Goltsman E, Reznik JG, Mosek A, Korczyn AD. The value of muscle exercise in patients with amyotrophic lateral sclerosis. J Neurol Sci. 2001 Oct 15;191(1-2):133-7. doi: 10.1016/s0022-510x(01)00610-4.
Results Reference
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The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

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