Amyotrophic Lateral SclerosisADVANCENCT03201991
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
A study testing Resistance Exercise Program in people with Amyotrophic Lateral Sclerosis, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Resistance Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 18 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Resistance Exercise Program
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise ProgramOther
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 group | Role | What they receive |
|---|---|---|
| Exercise Program | Other | Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening. Receives: Other: Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional muscle strength
determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 May 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Jawdat, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201991
- Sponsor's protocol ID
- STUDY00003843
- Acronym
- ADVANCE
- Status last verified
- Dec 2019
- First submitted
- 26 Jun 2017
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
- ClinicalTrials.gov ID
- NCT03201991
- Acronym / sponsor ID
- ADVANCE / STUDY00003843
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Other | Other: Resistance Exercise ProgramParticipants will be asked to take part in an exercise program that is focused on quadriceps strengthening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise ProgramThe 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. | Other | Exercise Program |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Jawdat, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Program in people with Amyotrophic Lateral Sclerosis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional muscle strength (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.