Study Purpose:
The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Resistance Exercise Program
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Omar Jawdat, MD, University of Kansas Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Kansas Medical Center
Kansas City, Kansas, 66160 United States
Full Study Summary:
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.
Study Sponsor:
University of Kansas Medical Center
Participant Duration:
12 weeks
Estimated Enrollment:
9
Estimated Study Start Date:
05 / 01 / 2017
Estimated Study Completion Date:
04 / 18 / 2018
Posting Last Modified Date:
12 / 19 / 2019
Date Study Added to neals.org:
06 / 28 / 2017
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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
University of Kansas Medical Center
Kansas City, Kansas
66160
United States