ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Change in functional muscle strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exercise Program
Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening.
Intervention: Resistance Exercise Program (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported