Trial Outcomes & Findings for FES Rowing for Skeletal Health After SCI (NCT NCT02008149)
NCT ID: NCT02008149
Last Updated: 2019-10-25
Results Overview
Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
0, 16, 29 and 43 weeks
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
FES-Rowers
Individuals with complete SCI participating in a 90-session FES-rowing program.
|
Standard-of-Care Controls
Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
|
Experienced FES-Rower
An individual with more than 10 years of FES-Rowing experience.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
1
|
|
Overall Study
COMPLETED
|
4
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FES Rowing for Skeletal Health After SCI
Baseline characteristics by cohort
| Measure |
FES-Rowers
n=7 Participants
Individuals with complete SCI participating in a 90-session FES-rowing program.
|
Standard-of-Care Controls
n=1 Participants
Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
|
Experienced FES-Rower
n=1 Participants
An individual with more than 10 years of FES-Rowing experience.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 Years
n=99 Participants
|
24 Years
n=107 Participants
|
59 Years
n=206 Participants
|
35 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Baseline Bone Mineral Density
|
216.1 g/cm^3
n=99 Participants
|
227.3 g/cm^3
n=107 Participants
|
251.2 g/cm^3
n=206 Participants
|
221.3 g/cm^3
n=7 Participants
|
PRIMARY outcome
Timeframe: 0, 16, 29 and 43 weeksPopulation: The only participant in the Stanford-of-Care Control group self-withdrew after 12 weeks of participation, after having a baseline measurement and one other bone density measurement. The participant in the Experienced FES-Rower group was only measured at baseline.
Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning.
Outcome measures
| Measure |
FES-Rowers
n=7 Participants
Individuals with complete SCI participating in a 90-session FES-rowing program.
|
Standard-of-Care Controls
n=1 Participants
Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
|
Experienced FES-Rower
n=1 Participants
An individual with more than 10 years of FES-Rowing experience.
|
|---|---|---|---|
|
Bone Mineral Density
Bone Mineral Density at 16 wks
|
184.0 g/cm^3
Interval 127.8 to 238.5
|
—
|
—
|
|
Bone Mineral Density
Bone Mineral Density at 29 wks
|
174.9 g/cm^3
Interval 97.2 to 229.6
|
—
|
—
|
|
Bone Mineral Density
Bone Mineral Density at 43 wks
|
188.5 g/cm^3
Interval 141.8 to 229.5
|
—
|
—
|
Adverse Events
FES-Rowers
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard-of-Care Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experienced FES-Rower
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FES-Rowers
n=7 participants at risk
Individuals with complete SCI participating in a 90-session FES-rowing program.
|
Standard-of-Care Controls
n=1 participants at risk
Individuals with complete SCI undergoing bone density scanning at four time points over 9 months.
|
Experienced FES-Rower
n=1 participants at risk
An individual with more than 10 years of FES-Rowing experience.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place