Electrical Stimulation During Immobilization

Neuromuscular Electrical Stimulation Clinical Trial

— ESDIM  

Official title:

The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513486
• Other study ID #: MEC 11-3-073
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: May 20, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male

• Aged from 18-35 years

• 18.5 < BMI < 30 kg/m2

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Disuse Atrophy
• Immobilization
• Neuromuscular Electrical Stimulation

Intervention

Behavioral:
• immobilization

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle mass, muscle fiber size		three days before immobilization, and directly after immobilization (day of cast removal; day 6)	No
Secondary	muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension		three days before immobilization, and directly after immobilization (day of cast removal; day 6)	No