Electrical Stimulation During Immobilization (ESDIM)
This study is currently recruiting participants.
Verified March 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01513486
First received: January 6, 2012
Last updated: March 14, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 6, 2012 | ||||||||
| Last Updated Date | March 14, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
muscle mass, muscle fiber size [ Time Frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6) ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01513486 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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) ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Electrical Stimulation During Immobilization | ||||||||
| Official Title ICMJE | The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: immobilization | ||||||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01513486 | ||||||||
| Other Study ID Numbers ICMJE | MEC 11-3-073 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Lex Verdijk, Maastricht University Medical Center | ||||||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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