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ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

NCT ID: NCT03201991

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-04-18

Brief Summary

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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

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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ALS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise Program

Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening.

Group Type OTHER

Resistance Exercise Program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Omar Jawdat, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003843

Identifier Type: -

Identifier Source: org_study_id