search
Back to results

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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise
Endurance Exercise
Stretching/Range-of-Motion
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Exercise, Resistance, Endurance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Resistance Exercise

Endurance Exercise

Stretching/Range-of-Motion Exercise

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Vital Capacity
Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)
ALS Functional Rating Scores
Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)
Muscle Strength
Evaluate the effect of resistance and endurance exercise on measures of muscle strength
Spasticity
Evaluate the effect of resistance and endurance exercise on spasticity
Fatigue
Evaluate the effect of resistance and endurance exercise on fatigue
Quality of Life
Evaluate the effect of resistance and endurance exercise on patient quality of life

Full Information

First Posted
January 24, 2012
Last Updated
April 18, 2016
Sponsor
Johns Hopkins University
Collaborators
ALS Association
search

1. Study Identification

Unique Protocol Identification Number
NCT01521728
Brief Title
Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
Official Title
Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
ALS Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, Exercise, Resistance, Endurance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Endurance Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stretching/Range-of-Motion Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
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
Intervention Name(s)
Endurance Exercise
Intervention Description
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
Intervention Name(s)
Stretching/Range-of-Motion
Intervention Description
Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.
Primary Outcome Measure Information:
Title
Resistance Exercise Tolerability
Description
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.
Time Frame
6 months
Title
Endurance Exercise Tolerability
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Vital Capacity
Description
Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)
Time Frame
6 months
Title
ALS Functional Rating Scores
Description
Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)
Time Frame
6 months
Title
Muscle Strength
Description
Evaluate the effect of resistance and endurance exercise on measures of muscle strength
Time Frame
6 months
Title
Spasticity
Description
Evaluate the effect of resistance and endurance exercise on spasticity
Time Frame
6 months
Title
Fatigue
Description
Evaluate the effect of resistance and endurance exercise on fatigue
Time Frame
6 months
Title
Quality of Life
Description
Evaluate the effect of resistance and endurance exercise on patient quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Subjects with a history of respiratory dysfunction not related to ALS (i.e. COPD) 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 Pregnancy Female subjects who are pregnant or planning to become pregnant. Female subjects of childbearing potential who are not practicing contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas M Maragakis, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs