Trial Outcomes & Findings for Novel Intervention to Influence Muscle Plasticity in Veterans (NCT NCT01093014)
NCT ID: NCT01093014
Last Updated: 2016-03-10
Results Overview
Muscle force evoked during high-force muscle stimulation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
up to 1 year
Results posted on
2016-03-10
Participant Flow
Participant milestones
| Measure |
Arm 1: High-force Muscle Stimulation
High-force muscle stimulation
|
Arm 2: Low-force Muscle Stimulation
Low-force muscle stimulation
|
Arm 3: Sequential Low-force and High-force Muscle Stimulation
Sequential low-force and high-force muscle stimulation
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
12
|
|
Overall Study
COMPLETED
|
12
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Intervention to Influence Muscle Plasticity in Veterans
Baseline characteristics by cohort
| Measure |
Arm 1: High-force Muscle Stimulation
n=12 Participants
High-force muscle stimulation
|
Arm 2: Low-force Muscle Stimulation
n=9 Participants
Low-force muscle stimulation
|
Arm 3: Sequential Low-force and High-force Muscle Stimulation
n=12 Participants
Sequential low-force and high-force muscle stimulation
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.33 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 32.3 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearMuscle force evoked during high-force muscle stimulation
Outcome measures
| Measure |
Arm 1: High-force Muscle Stimulation
n=12 Participants
High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 2: Low-force Muscle Stimulation
Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 3: Sequential Low-force and High-force Muscle Stimulation
n=12 Participants
Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
|
|---|---|---|---|
|
HF Muscle Force
|
23.9 Newtons (N)
Standard Deviation 5.9
|
—
|
30.9 Newtons (N)
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: up to 1 yearMuscle force evoked during low-force muscle stimulation
Outcome measures
| Measure |
Arm 1: High-force Muscle Stimulation
High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 2: Low-force Muscle Stimulation
n=9 Participants
Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 3: Sequential Low-force and High-force Muscle Stimulation
n=12 Participants
Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
|
|---|---|---|---|
|
LF Muscle Force
|
—
|
26.72 N (newtons)
Standard Deviation 19.03
|
27.58 N (newtons)
Standard Deviation 4.41
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.
Messenger ribonucleic acid (mRNA) expression fold-change for myostatin (MSTN). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.
Outcome measures
| Measure |
Arm 1: High-force Muscle Stimulation
n=3 Participants
High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 2: Low-force Muscle Stimulation
Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 3: Sequential Low-force and High-force Muscle Stimulation
n=6 Participants
Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
|
|---|---|---|---|
|
Skeletal Muscle Gene Regulation: MSTN
|
.56 fold-change
Standard Deviation .06
|
—
|
.67 fold-change
Standard Deviation .40
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.
Messenger ribonucleic acid (mRNA) expression fold-change for peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PPARGC1A). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.
Outcome measures
| Measure |
Arm 1: High-force Muscle Stimulation
n=3 Participants
High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 2: Low-force Muscle Stimulation
Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Arm 3: Sequential Low-force and High-force Muscle Stimulation
n=6 Participants
Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
|
|---|---|---|---|
|
Skeletal Muscle Gene Expression: PPARGC1A
|
5.46 fold-change
Standard Deviation .64
|
—
|
4.97 fold-change
Standard Deviation 3.5
|
Adverse Events
Arm 1: High-force Muscle Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Low-force Muscle Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Sequential Low-force and High-force Muscle Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard K. Shields PhD, PT
University of Iowa / Iowa City VA Medical Center
Phone: 319-335-9791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place