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

NCT01521728 | Completed DMC

• 1 other identifier: NA_00022650
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Keywords

ALS; Exercise; Resistance; Endurance

Outcome Measures

Primary Outcomes (2)

• Resistance Exercise Tolerability

  Evaluate the tolerability of RESISTANCE exercise in ALS subjects as measured by their ability to complete a 6 month study of a resistance exercise regimen.

  6 months

• Endurance Exercise Tolerability

  Evaluate the tolerability of ENDURANCE exercise in ALS subjects as measured by their ability to complete a 6 month study of an endurance exercise regimen.

  6 months

Secondary Outcomes (6)

• Vital Capacity

  6 months

• ALS Functional Rating Scores

  6 months

• Muscle Strength

  6 months

• Spasticity

  6 months

• Fatigue

  6 months

Study Arms (3)

Resistance Exercise

ACTIVE COMPARATOR

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.

Other: Resistance Exercise

Endurance Exercise

ACTIVE COMPARATOR

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.

Other: Endurance Exercise

Stretching/Range-of-Motion Exercise

ACTIVE COMPARATOR

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.

Other: Stretching/Range-of-Motion

Interventions

Resistance Exercise 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.

Resistance Exercise

Endurance Exercise 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.

Endurance Exercise

Stretching/Range-of-Motion OTHER

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

Stretching/Range-of-Motion Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the WFN El Escorial criteria
• Participants who are ages 18-80, inclusive.
• Slow Vital Capacity (SVC) must be equal to or greater than 70% of predicted value
• ALSFRS-R score \>30.
• Patients who are currently on any medications must be on a stable dose for the past 30 days.
• Participants must provide informed consent prior to completion of any study procedures.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• ALS Association: collaborator

Study Sites (4)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Activity

Interventions

Resistance Training; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nicholas M Maragakis, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

US (4)