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

December 17, 2019 updated by: University of Kansas Medical Center
The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Omar Jawdat, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003843

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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