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Completed

NCT Number: NCT03201991

ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

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

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Exercise Program

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: ADVANCE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2017
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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