Disuse AtrophyESDIMNCT01513486
Electrical Stimulation During Immobilization
A study testing immobilization in people with Disuse Atrophy and Immobilization, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Disuse Atrophy, Immobilization, Neuromuscular Electrical Stimulation
- What is being tested?
- immobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Jan 2013
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Who cannot join
- Smoking
- Performing regular resistance training in the previous 6 months
- Hypertension (according to WHO criteria) [46] and/or cardiovascular disease
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
- Use of any prescribed medication
- Type 2 diabetes mellitus
Show all 10Show fewer
- Any family history of thrombosis
- All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- Myocardial infarction within the last 3 years
- Use of anti-coagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men
In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.
- Being tested
- immobilization
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immobilizationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Immobilization with NMES | Experimental | Immobilization with daily NMES Receives: Behavioral: immobilization |
| Immobilization without NMES | Placebo comparator | Immobilization without daily NMES Receives: Behavioral: immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass, muscle fiber size
Measured: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Secondary outcomes (1)
muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
Measured: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disuse AtrophyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex Verdijk, Maastricht University Medical Center
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513486
- Sponsor's protocol ID
- MEC 11-3-073
- Acronym
- ESDIM
- Status last verified
- May 2013
- First submitted
- 6 Jan 2012
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men
- ClinicalTrials.gov ID
- NCT01513486
- Acronym / sponsor ID
- ESDIM / MEC 11-3-073
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Jan 2012 (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.
In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilization with NMES | Experimental | Behavioral: immobilizationImmobilization with daily NMES |
| Immobilization without NMES | Placebo comparator | Behavioral: immobilizationImmobilization without daily NMES |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Key exclusion criteria (10 listed)
- Smoking
- Performing regular resistance training in the previous 6 months
- Hypertension (according to WHO criteria) [46] and/or cardiovascular disease
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
- Use of any prescribed medication
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 |
|---|---|---|
| immobilization | Behavioural | Immobilization with NMES, Immobilization without NMES |
Primary outcome
muscle mass, muscle fiber size
Time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
1 secondary outcome
muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
Time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
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 22 May 2013.
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Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
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Cross-education of Skill and Strength in Healthy People Subjected to an Upper-limb Disuse Model
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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.
Luc JC van Loon, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immobilization in people with Disuse Atrophy and Immobilization, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 10 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 22 May 2013. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
muscle mass, muscle fiber size (time frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)). 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 22 May 2013.