Electrical Stimulation for Attenuating Muscle Atrophy
NCT02321163 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2016-02-25
Summary
Objectives: This study aims to examine the use of low frequency (2Hz), low amplitude (intensity just produce visible muscle contraction), and long duration (2x3 hrs/day) neuromuscular electrical simulation (NMES) in attenuating the effects of muscle atrophy resulted from disuse.
Design and subjects: The study is a randomized, double-blind, controlled, and parallel group study. Subjects with stable chronic obstructive pulmonary disease (COPD) will be included. Intervention: Subjects will be randomized to 3 groups to receive different NMES program over the quadriceps and calf muscles: (i) the proposed NMES program; (ii) conventional NMES program (50Hz, 30 min/day), or sham group for a period of 8 weeks.
Outcome measures:The effectiveness of the NMES will be evaluated by the improvement in muscle cross-sectional area (CSA), muscle performance (muscle strength, muscle shortening velocity and muscle activation testing), functional performance (6 min walk) and subjects' rating of the perceived acceptability of the stimulation protocol.
Data analysis: Baseline characteristics of the intervention and sham groups will be compared using one way ANOVA. Two-way mixed repeated measures analysis of variance will be performed to examine the differences between groups over time for all the outcome variables. The significance level is set at p \< 0.05.
Expected results: The investigators hypothesize that the proposed new paradigm of NMES would be more effective in improving muscle cross-sectional area (CSA), strength, endurance, and exercise tolerance.
Conditions
Interventions
- DEVICE
-
NMES new paradigm
stimulation frequency: 2 Hz; intensity: low amplitude; duration: 3 hours, 2 times per day for 8 weeks
- DEVICE
-
NMES conventional
stimulation frequency: 50 Hz; intensity: maximally tolerated; duration: 30 min per day for 8 weeks
- DEVICE
-
NMES no stimulation
Placebo, electrode pad on, no stimulation
Sponsors & Collaborators
-
The Hong Kong Polytechnic University
lead OTHER
Principal Investigators
-
Simon S Yeung, PhD · The Hong Kong Polytechnic University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2016-12-31
- Completion
- 2017-05-31
Countries
- Hong Kong
Study Locations
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