ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03201991

Acronym

ADVANCE

Enrollment

Registered

2017-06-28

Start date

2017-05-01

Completion date

2018-04-18

Last updated

2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS

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.

Interventions

OTHERResistance 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026