ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

Amyotrophic Lateral Sclerosis Clinical Trial

— ADVANCE  

Official title:

ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201991
• Other study ID #: STUDY00003843
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: December 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional muscle strength	determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise	Week 12