Back to resultsALS Study Determining Various Biomarkers and Strength Comparison After Exercise (ADVANCE)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise Program
Sponsored by
About this trial
This is an interventional prevention trial for Amyotrophic Lateral Sclerosis focused on measuring ALS
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise Program
Arm Description
Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening.
Outcomes
Primary Outcome Measures
Change in functional muscle strength
determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise
Secondary Outcome Measures
Full Information
NCT ID
NCT03201991
First Posted
June 26, 2017
Last Updated
December 17, 2019
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03201991
Brief Title
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
Acronym
ADVANCE
Official Title
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Program
Arm Type
Other
Arm Description
Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Program
Intervention Description
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 Measure Information:
Title
Change in functional muscle strength
Description
determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Jawdat, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
We'll reach out to this number within 24 hrs