Trial Outcomes & Findings for Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors (NCT NCT02739620)
NCT ID: NCT02739620
Last Updated: 2023-04-11
Results Overview
Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Difference between values at baseline at 2 months
Results posted on
2023-04-11
Participant Flow
Participant milestones
| Measure |
NMES
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
Control group
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
Baseline Testing
|
12
|
10
|
|
Overall Study
Intervention Phase
|
10
|
10
|
|
Overall Study
Post-intervention Testing
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
NMES
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
Control group
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Baseline characteristics by cohort
| Measure |
NMES
n=12 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=10 Participants
Control group
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 5.5 • n=93 Participants
|
55.5 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
54.5 years
STANDARD_DEVIATION 7.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
10 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Weight
|
75.0 kilograms
STANDARD_DEVIATION 15.1 • n=93 Participants
|
71.2 kilograms
STANDARD_DEVIATION 14.2 • n=4 Participants
|
73.2 kilograms
STANDARD_DEVIATION 14.5 • n=27 Participants
|
|
Height
|
163.4 centimeters
STANDARD_DEVIATION 10.5 • n=93 Participants
|
161.6 centimeters
STANDARD_DEVIATION 6.9 • n=4 Participants
|
162.6 centimeters
STANDARD_DEVIATION 8.8 • n=27 Participants
|
|
Percentage of body fat
|
42.4 percent
STANDARD_DEVIATION 7 • n=93 Participants
|
39.9 percent
STANDARD_DEVIATION 5.9 • n=4 Participants
|
41.3 percent
STANDARD_DEVIATION 6.5 • n=27 Participants
|
|
Fat mass
|
31.9 kilograms
STANDARD_DEVIATION 10.6 • n=93 Participants
|
28.3 kilograms
STANDARD_DEVIATION 8.8 • n=4 Participants
|
30.2 kilograms
STANDARD_DEVIATION 9.8 • n=27 Participants
|
|
Fat-free mass
|
41.5 kilograms
STANDARD_DEVIATION 5.4 • n=93 Participants
|
41.3 kilograms
STANDARD_DEVIATION 6.4 • n=4 Participants
|
41.4 kilograms
STANDARD_DEVIATION 5.7 • n=27 Participants
|
|
Appendicular skeletal muscle mass
|
25.3 kilograms
STANDARD_DEVIATION 3.9 • n=93 Participants
|
24.7 kilograms
STANDARD_DEVIATION 5.2 • n=4 Participants
|
25.0 kilograms
STANDARD_DEVIATION 4.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: Difference between values at baseline at 2 monthsPopulation: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.
Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=8 Participants
Control group
|
|---|---|---|
|
Maximal Calcium-activated Tension Single Muscle Fiber Tension
Baseline testing
|
185 milliNewtons per millimeter^2
Standard Error 10
|
172 milliNewtons per millimeter^2
Standard Error 10
|
|
Maximal Calcium-activated Tension Single Muscle Fiber Tension
Post-intervention testing
|
172 milliNewtons per millimeter^2
Standard Error 9
|
168 milliNewtons per millimeter^2
Standard Error 10
|
PRIMARY outcome
Timeframe: Difference between values at baseline at 2 monthsPopulation: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=8 Participants
Control group
|
|---|---|---|
|
Cross-sectional Area of Skeletal Muscle Fibers
Baseline testing
|
2432 micrometers^2
Standard Error 246
|
2320 micrometers^2
Standard Error 261
|
|
Cross-sectional Area of Skeletal Muscle Fibers
Post-intervention testing
|
2694 micrometers^2
Standard Error 246
|
2381 micrometers^2
Standard Error 260
|
PRIMARY outcome
Timeframe: Difference between values at baseline at 2 monthsPopulation: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing and the fact that electron microscopy measures could not be completed on one volunteer because of insufficient muscle tissue.
Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=7 Participants
Control group
|
|---|---|---|
|
Intermyofibrillar Mitochondrial Content
Baseline testing
|
2.72 percentage of image area
Standard Error 0.24
|
2.62 percentage of image area
Standard Error 0.26
|
|
Intermyofibrillar Mitochondrial Content
Post-intervention testing
|
2.75 percentage of image area
Standard Error 0.25
|
2.56 percentage of image area
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Difference between values at baseline at 2 monthsPopulation: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.
Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis. The velocity of contraction is expressed relative to the length of the muscle fiber segment evaluated (as measured using a eyepiece micrometer during assessments) per second.
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=8 Participants
Control group
|
|---|---|---|
|
Single Muscle Fiber Contractile Velocity
Baseline testing
|
2.1 muscle lengths per second
Standard Error 0.08
|
1.92 muscle lengths per second
Standard Error 0.09
|
|
Single Muscle Fiber Contractile Velocity
Post-intervention testing
|
1.92 muscle lengths per second
Standard Error 0.9
|
1.73 muscle lengths per second
Standard Error 0.8
|
Adverse Events
NMES
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NMES
n=12 participants at risk
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=10 participants at risk
Control group
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
0.00%
0/12 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
NMES
n=12 participants at risk
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
|
Control
n=10 participants at risk
Control group
|
|---|---|---|
|
Infections and infestations
Febrile episode
|
0.00%
0/12 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place