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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521728
• Other study ID #: NA_00022650
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: April 18, 2016
• Start date: January 2012
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• 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.
• 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.
• Stretching/Range-of-Motion
Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	ALS Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Vital Capacity	Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)	6 months	No
Secondary	ALS Functional Rating Scores	Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)	6 months	No
Secondary	Muscle Strength	Evaluate the effect of resistance and endurance exercise on measures of muscle strength	6 months	No
Secondary	Spasticity	Evaluate the effect of resistance and endurance exercise on spasticity	6 months	No
Secondary	Fatigue	Evaluate the effect of resistance and endurance exercise on fatigue	6 months	No
Secondary	Quality of Life	Evaluate the effect of resistance and endurance exercise on patient quality of life	6 months	No