HealthyLCTNCT00575107
A System for Lengthening Contraction Training of Muscle
A study testing Exercise in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
Evaluation of a new exercise machine designed to improve strength and speed of movement in the leg muscles. Investigators are trying to learn whether a new training method results in greater strength improvements as compared to a traditional method. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2009
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- healthy
- able to exercise 3 times per week for 16 weeks at Mobility Research Center
Who cannot join
- under- or overweight
- chronic disease that limits ability to exercise
- hips and legs limited by arthritis or pain
- presently engaged in a strenuous exercise program
- planned absence greater than one week.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of a new exercise machine designed to improve strength and speed of movement in the leg muscles. Investigators are trying to learn whether a new training method results in greater strength improvements as compared to a traditional method.
- Conditions
- Healthy
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Velocity-controlled variable resistance protocols enable trainees to load their muscles more optimally along the entire ROM in either or both of the shortening (VSC) and lengthening (VLC) phases of a training repetition
ExerciseOther
Standard training of leg extension
| Study group | Role | What they receive |
|---|---|---|
| VSC-VLC | Experimental | velocity-controlled variable resistance, lengthening contraction Receives: Other: Exercise |
| SC | Active comparator | Constant weight shortening contraction Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg strength
Measured: 16 weeks
Secondary outcomes (1)
Ability to rise from a chair
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- BioLogic Engineering, Inc.
- Investigators
- Neil Alexander, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575107
- Sponsor's protocol ID
- 2005-0319
- Acronym
- LCT
- Status last verified
- Jan 2010
- First submitted
- 14 Dec 2007
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A System for Lengthening Contraction Training of Muscle
- ClinicalTrials.gov ID
- NCT00575107
- Acronym / sponsor ID
- LCT / 2005-0319
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- BioLogic Engineering, Inc.
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Dec 2007 (estimated)
- 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.
Evaluation of a new exercise machine designed to improve strength and speed of movement in the leg muscles. Investigators are trying to learn whether a new training method results in greater strength improvements as compared to a traditional method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSC-VLC | Experimental | Other: Exercisevelocity-controlled variable resistance, lengthening contraction |
| SC | Active comparator | Other: ExerciseConstant weight shortening contraction |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- healthy
- able to exercise 3 times per week for 16 weeks at Mobility Research Center
Key exclusion criteria (5 listed)
- under- or overweight
- chronic disease that limits ability to exercise
- hips and legs limited by arthritis or pain
- presently engaged in a strenuous exercise program
- planned absence greater than one week.
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 |
|---|---|---|
| ExerciseVelocity-controlled variable resistance protocols enable trainees to load their muscles more optimally along the entire ROM in either or both of the shortening (VSC) and lengthening (VLC) phases of a training repetition | Other | VSC-VLC |
| ExerciseStandard training of leg extension | Other | SC |
Primary outcome
Leg strength
Time frame: 16 weeks
1 secondary outcome
Ability to rise from a chair
Time frame: 16 weeks
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 4 Aug 2011.
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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.
Neil Alexander, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy, run by University of Michigan 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 2 inclusion and 5 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 4 Aug 2011. 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?
Leg strength (time frame: 16 weeks). 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 4 Aug 2011.