Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT01521728

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-02-29

Brief Summary

The first questions asked by patients with a new diagnosis of Amyotrophic Lateral Sclerosis (ALS) often include: "Does exercise help slow the progression of the disease?", "Is there any harm in exercising?", or "What type of exercise (endurance or resistance) is most appropriate?" At this time, however, there is a lack of answers for people who suffer from an illness that affects their strength above all else. Yet the beneficial effects of exercise in both healthy people as well as people with other diseases have been extensively studied and resulted in recommendations about the types of exercise that are beneficial. In this study the investigators will ask participants with ALS to exercise in one of three ways: weightlifting (resistance exercise), stationary bicycling (endurance exercise), and range of motion exercise (the current "standard of care" for ALS patients). The investigators will use several different types of tests to determine whether one type of exercise is tolerated better and is safer than another. The investigators will also collect information about how the body responds to exercise in ALS. This study will help in the development of a larger national study to understand how exercise can be combined with other treatments to potentially improve strength and alter the course of the disease.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Resistance Exercise

Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.

Group Type: ACTIVE_COMPARATOR

Resistance Exercise

Intervention Type: OTHER

Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.

Endurance Exercise

Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.

Group Type: ACTIVE_COMPARATOR

Endurance Exercise

Intervention Type: OTHER

Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.

Stretching/Range-of-Motion Exercise

In ALS, stretching and range of motion are routinely recommended for the prevention of "frozen shoulder syndrome" and contractures resulting from weakness. The problem is compounded in ALS where upper motor neuron dysfunction may result in spasticity and incapacitating contractures with pain. Therefore, maintaining an aggressive program for stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.

Group Type: ACTIVE_COMPARATOR

Stretching/Range-of-Motion

Intervention Type: OTHER

Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.

Interventions

Resistance Exercise

Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.

Intervention Type: OTHER

Endurance Exercise

Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.

Intervention Type: OTHER

Stretching/Range-of-Motion

Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participants with familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the WFN El Escorial criteria

2. Participants who are ages 18-80, inclusive.

3. Slow Vital Capacity (SVC) must be equal to or greater than 70% of predicted value

4. ALSFRS-R score >30.

5. Patients who are currently on any medications must be on a stable dose for the past 30 days.

6. Participants must provide informed consent prior to completion of any study procedures.

Exclusion Criteria

1. Participants who are already performing >30 min. of endurance exercise/day for ≥ 3x/week (Borg scale-- "hard" or "somewhat hard") within 30 days of screening.

2. Participants who are already performing resistance exercise ≥ 3x/week within 30 days of screening.

3. Neurologic

• Participants with history of ALS symptoms over 5 years duration
• Inability to obtain consent (psychiatric or dementing illness)
• History of neuromuscular dysfunction not related to ALS

4. Cardiac

• Patents with clinically significant ECG abnormalities
• Uncontrolled hypertension (SBP>160 or DBP>110)
• Recent history of angina (within the last 2 years)
• Recent history of abnormal stress test (within the last 2 years)
• Symptomatic severe aortic stenosis
• Active endocarditis
• Symptomatic heart failure

5. Respiratory

• Subjects with a history of respiratory dysfunction not related to ALS (i.e. COPD)

6. General

• Subjects with chronic infectious disease including HIV, hepatitis B or C.
• History of substance abuse within the past year
• Patients who have a history of poor compliance to medical regimens or study requirements.
• Uncontrolled diabetes
• Recent embolism (within the last 6 months)
• Severe orthopedic conditions that would prohibit exercise

7. Pregnancy

• Female subjects who are pregnant or planning to become pregnant.
• Female subjects of childbearing potential who are not practicing contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALS Association

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Maragakis, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas M Maragakis, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

NA_00022650

Identifier Type: -

Identifier Source: org_study_id