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ALS Study Determining Various Biomarkers and Strength Comparison After Exercise (ADVANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201991
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Resistance Exercise Program Not Applicable

Detailed Description:
Study participation lasts a total of three months and includes two study visits. Subjects are asked to undergo strength testing, physical exams, lab draws, and muscle biopsies at each study visit. Muscle biopsies are done in the quadriceps muscle. In between study visits, subjects are asked to maintain a weekly exercise regimen given to them by the study physical therapist.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018


Arm Intervention/treatment
Exercise Program
Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening.
Other: Resistance Exercise Program
The resistance exercise program will involve three sets of 10 repetitions of each exercise in levels 1 and 2 every day. Participants will be given instructions to follow.




Primary Outcome Measures :
  1. Change in functional muscle strength [ Time Frame: Week 12 ]
    determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria
  • Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation
  • Ipsilateral quadriceps femoris strength: >=4
  • Ambulatory with or without assistance
  • Revised ALS Functional Rating Scale (ALSFRS-R) Score > 30
  • Forced expiratory vital capacity (FVC) >50% of predicted

Exclusion Criteria:

  • ALSFRS-R ≤ 30
  • Quadriceps femoris strength <4
  • Unable to walk or uses wheelchair as primary means of mobility
  • More than mild atrophy of quadriceps
  • Bleeding disorder or uptake of anticoagulants
  • Unwilling to comply with exercise and needle muscle biopsy
  • Not a good research candidate according to the medical opinion of investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201991


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Omar Jawdat, MD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03201991    
Other Study ID Numbers: STUDY00003843
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
ALS
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases