Trial Outcomes & Findings for Exercise to Reduce Obesity in Spinal Cord Injury (NCT NCT00270855)

NCT ID: NCT00270855

Last Updated: 2017-11-17

Results Overview

Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: baseline, 16 weeks
• Results posted on: 2017-11-17

Participant Flow

Participant milestones

Measure	Arm Crank Ergometer Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Overall Study STARTED	15	14
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Measure	Arm Crank Ergometer Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Overall Study Withdrawal by Subject	8	8

Baseline Characteristics

Exercise to Reduce Obesity in Spinal Cord Injury

Baseline characteristics by cohort

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise	Total n=13 Participants Total of all reporting groups
Bone Mineral Density	1.138 g/cm^2 STANDARD_DEVIATION 0.104 • n=5 Participants	1.293 g/cm^2 STANDARD_DEVIATION 0.135 • n=7 Participants	1.209 g/cm^2 STANDARD_DEVIATION 0.140 • n=5 Participants
Total Cholesterol	176 mg/dl STANDARD_DEVIATION 29 • n=5 Participants	167 mg/dl STANDARD_DEVIATION 49 • n=7 Participants	172 mg/dl STANDARD_DEVIATION 38 • n=5 Participants
HDL-Cholesterol	35.7 mg/dl STANDARD_DEVIATION 6.4 • n=5 Participants	37.8 mg/dl STANDARD_DEVIATION 8.3 • n=7 Participants	36.7 mg/dl STANDARD_DEVIATION 7.1 • n=5 Participants
Age, Continuous	42 Years STANDARD_DEVIATION 10 • n=5 Participants	39 Years STANDARD_DEVIATION 14 • n=7 Participants	40.5 Years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
% Body Fat	38.9 Percent Body Fat STANDARD_DEVIATION 6.9 • n=5 Participants	41.6 Percent Body Fat STANDARD_DEVIATION 7.1 • n=7 Participants	40.75 Percent Body Fat STANDARD_DEVIATION 7.4 • n=5 Participants
Fat Mass (Kg)	29.6 Kg STANDARD_DEVIATION 6.4 • n=5 Participants	33.4 Kg STANDARD_DEVIATION 11.0 • n=7 Participants	31.5 Kg STANDARD_DEVIATION 8.7 • n=5 Participants
Fat-Free Mass (kg)	49.6 Kg STANDARD_DEVIATION 9.1 • n=5 Participants	49.5 Kg STANDARD_DEVIATION 11.2 • n=7 Participants	49.55 Kg STANDARD_DEVIATION 10.15 • n=5 Participants
Glucose Effectiveness (Sg)	0.023 min^-1 STANDARD_DEVIATION 0.01 • n=5 Participants	0.017 min^-1 STANDARD_DEVIATION 0.01 • n=7 Participants	0.02 min^-1 STANDARD_DEVIATION 0.01 • n=5 Participants
Insulin Sensitivity (Si)	3.0 μu/ml STANDARD_DEVIATION 2.0 • n=5 Participants	2.7 μu/ml STANDARD_DEVIATION 2.0 • n=7 Participants	2.85 μu/ml STANDARD_DEVIATION 2 • n=5 Participants
Exercise Energy Expenditure (Kcal/session)	128.3 Kcal/session STANDARD_DEVIATION 35.4 • n=5 Participants	80.7 Kcal/session STANDARD_DEVIATION 32.6 • n=7 Participants	101 Kcal/session STANDARD_DEVIATION 34 • n=5 Participants
Resting Metabolic Rate	1442 Kcal/d STANDARD_DEVIATION 348 • n=5 Participants	1710 Kcal/d STANDARD_DEVIATION 974 • n=7 Participants	1565 Kcal/d STANDARD_DEVIATION 689 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in % Body Fat	-1.83 Percent Body Fat Standard Deviation 2.72	-1.68 Percent Body Fat Standard Deviation 0.98

PRIMARY outcome

Timeframe: Baseline, 16 Weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Fat Mass	-1.84 Kg Standard Deviation 1.99	-1.02 Kg Standard Deviation 2.55

PRIMARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Fat-Free Mass	0.90 Kg Standard Deviation 3.49	1.86 Kg Standard Deviation 2.42

PRIMARY outcome

Timeframe: Baseline, 16-weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Glucose Effectiveness (Sg)	0.00 min^-1 Standard Deviation 0.02	0.01 min^-1 Standard Deviation 0.01

PRIMARY outcome

Timeframe: Baseline, 16-weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Insulin Sensitivity (Si)	10.1 min^-1 Standard Deviation 25.3	5.28 min^-1 Standard Deviation 12.4

PRIMARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
%Body Fat Between Groups	37.1 Percent Body Fat Standard Deviation 5.6	39.9 Percent Body Fat Standard Deviation 6.8

PRIMARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Fat Mass Between Groups	29.6 kg Standard Deviation 6.4	33.4 kg Standard Deviation 11.0

PRIMARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Fat Free Mass Between Groups	50.5 kg Standard Deviation 10.4	51.3 kg Standard Deviation 12.8

PRIMARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Insulin Sensitivity (Si) Between Groups	13.7 min^-1 Standard Deviation 0.02	8.4 min^-1 Standard Deviation 12.9

PRIMARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Glucose Effectiveness (Sg) Between Groups	.03 min^-1 Standard Deviation 0.009	0.02 min^-1 Standard Deviation 0.009

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Lower Limb Bone Mineral Density	0.02 g*(cm^2)^-1 Standard Deviation 0.03	-0.01 g*(cm^2)^-1 Standard Deviation 0.02

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Lower Limb Bone Mineral Content	-0.07 grams Standard Deviation 0.14	-0.06 grams Standard Deviation 0.09

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Triglycerides	-1.14 mg/dL Standard Deviation 22.6	-12.33 mg/dL Standard Deviation 8.19

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in High Density Lipoprotein Cholesterol (HDL)	-2.29 mg/dL Standard Deviation 3.55	0.07 mg/dL Standard Deviation 2.63

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Low Density Lipoprotein Cholesterol (LDL)	0.14 mg/dL Standard Deviation 20.7	1.43 mg/dL Standard Deviation 24.3

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Total Cholesterol (TC)	-1.14 mg/dL Standard Deviation 22.6	-12.33 mg/dL Standard Deviation 8.19

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)	0.24 Ratio Standard Deviation 0.59	-0.22 Ratio Standard Deviation 0.79

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Lower Limb Bone Mineral Density Between Groups	1.15 g*(cm^2)^-1 Standard Deviation 0.12	1.28 g*(cm^2)^-1 Standard Deviation 0.12

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Lower Limb Bone Mineral Content Between Groups	3.37 grams Standard Deviation 0.64	2.88 grams Standard Deviation 0.55

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Triglycerides Between Groups	87.33 mg/dL Standard Deviation 46.7	103.6 mg/dL Standard Deviation 65.16

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
High Density Lipoprotein Cholesterol (HDL) Between Groups	33.43 mg/dL Standard Deviation 5.1	37.8 mg/dL Standard Deviation 8.3

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Low Density Lipoprotein Cholesterol (LDL) Between Groups	118.3 mg/dL Standard Deviation 32.2	107.3 mg/dL Standard Deviation 35.2

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of TC between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Total Cholesterol (TC) Between Groups	172.0 mg/dL Standard Deviation 28.6	163.7 mg/dL Standard Deviation 38.9

SECONDARY outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups	5.3 Ratio Standard Deviation 1.4	4.5 Ratio Standard Deviation 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Change in Resting Metabolic Rate	-131.7 kcal/day Standard Deviation 393	-322.0 kcal/day Standard Deviation 963

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention

Outcome measures

Measure	Arm Cycling Ergometer n=7 Participants Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	FESLCE n=6 Participants Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Resting Metabolic Rate Between Groups	1309.06 kcal/day Standard Deviation 167.9	1387.8 kcal/day Standard Deviation 392.3

Adverse Events

Arm Cycling Ergometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FESLCE

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

Dr. David Gater

Penn State Hershey Medical Center

Phone: 7175314263

Email: dgater@hmc.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place