Trial Outcomes & Findings for The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial (NCT NCT01834144)
NCT ID: NCT01834144
Last Updated: 2018-09-20
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Measured at baseline, and 1, 8,16 and 52 weeks following randomization
Results posted on
2018-09-20
Participant Flow
Participant milestones
| Measure |
Moderate Intensity Exercise
150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)
Exercise Training
|
Moderate + Vigorous Intensity Exercise
150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)
Exercise Training
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study funding not renewed; do data analyzed
Baseline characteristics by cohort
| Measure |
Moderate Intensity Exercise
n=1 Participants
150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)
Exercise Training
|
Moderate + Vigorous Intensity Exercise
n=3 Participants
150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)
Exercise Training
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
0 years
STANDARD_DEVIATION 0 • n=1 Participants
|
0 years
STANDARD_DEVIATION 0 • n=3 Participants
|
0 years
STANDARD_DEVIATION 0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
Study funding not renewed; do data analyzed
|
0 Participants
Study funding not renewed; do data analyzed
|
0 Participants
Study funding not renewed; do data analyzed
|
|
Sex: Female, Male
Male
|
0 Participants
Study funding not renewed; do data analyzed
|
0 Participants
Study funding not renewed; do data analyzed
|
0 Participants
Study funding not renewed; do data analyzed
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Measured at baseline, and 1, 8,16 and 52 weeks following randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline, and 1, 8, 16 and 52 weeks following randomizationOutcome measures
Outcome data not reported
Adverse Events
Moderate Intensity Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate + Vigorous Intensity Exercise
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place