Trial Outcomes & Findings for Exploration of Blood Flow Regulation to Bone in Humans (NCT NCT04083794)
NCT ID: NCT04083794
Last Updated: 2024-06-17
Results Overview
Concentration of hemoglobin content assessed in response to several physical maneuvers (isometric handgrip exercise, cold pressor test, nitroglycerin, reactive hyperemia, leg dependency). Results are reported in tibial total hemoglobin content (μM). To date there are no absolute established values of tibial bone hemoglobin content and thus an absolute range (minimum and maximum) cannot be provided.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
1 day
Results posted on
2024-06-17
Participant Flow
The current study does not assign participants to arms; it is a cross-sectional assessment where all participants will undergo the same procedures. Upon enrollment, all participants underwent laboratory based assessments.
Participant milestones
| Measure |
Laboratory Based Assessments
The current study has no arms; it is a cross-sectional assessment where all participants will undergo the same procedures.
Laboratory based assessments: physical maneuvers to assess physiological responses in bone blood flow
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Laboratory Based Assessments
The current study has no arms; it is a cross-sectional assessment where all participants will undergo the same procedures.
Laboratory based assessments: physical maneuvers to assess physiological responses in bone blood flow
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
Baseline Characteristics
Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
Baseline characteristics by cohort
| Measure |
Laboratory Based Assessments
n=81 Participants
The current study has no arms; it is a cross-sectional assessment where all participants will undergo the same procedures.
Laboratory based assessments: this is a cross-sectional study including physical maneuvers to assess physiological responses in bone blood flow in young healthy adults and adults with spinal cord injury.
|
|---|---|
|
Age, Categorical
Uninjured controls · <=18 years
|
0 Participants
n=67 Participants • Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
|
|
Age, Categorical
Uninjured controls · Between 18 and 65 years
|
67 Participants
n=67 Participants • Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
|
|
Age, Categorical
Uninjured controls · >=65 years
|
0 Participants
n=67 Participants • Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
|
|
Age, Categorical
Spinal cord injury individuals · <=18 years
|
0 Participants
n=14 Participants • Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
|
|
Age, Categorical
Spinal cord injury individuals · Between 18 and 65 years
|
14 Participants
n=14 Participants • Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
|
|
Age, Categorical
Spinal cord injury individuals · >=65 years
|
0 Participants
n=14 Participants • Overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14)
|
|
Sex: Female, Male
Uninjured controls · Female
|
30 Participants
n=67 Participants • The overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14).
|
|
Sex: Female, Male
Uninjured controls · Male
|
37 Participants
n=67 Participants • The overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14).
|
|
Sex: Female, Male
Spinal cord injury individuals · Female
|
1 Participants
n=14 Participants • The overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14).
|
|
Sex: Female, Male
Spinal cord injury individuals · Male
|
13 Participants
n=14 Participants • The overall number (81) includes both uninjured controls (67) and spinal cord injured individuals (14).
|
|
Ethnicity (NIH/OMB)
Uninjured controls · Hispanic or Latino
|
5 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Ethnicity (NIH/OMB)
Uninjured controls · Not Hispanic or Latino
|
60 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Ethnicity (NIH/OMB)
Uninjured controls · Unknown or Not Reported
|
2 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Ethnicity (NIH/OMB)
Spinal cord injured individuals · Hispanic or Latino
|
2 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Ethnicity (NIH/OMB)
Spinal cord injured individuals · Not Hispanic or Latino
|
11 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Ethnicity (NIH/OMB)
Spinal cord injured individuals · Unknown or Not Reported
|
1 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · American Indian or Alaska Native
|
1 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · Asian
|
7 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · Black or African American
|
1 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · White
|
50 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · More than one race
|
1 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Uninjured controls · Unknown or Not Reported
|
7 Participants
n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · American Indian or Alaska Native
|
0 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · Asian
|
1 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · Black or African American
|
1 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · White
|
11 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · More than one race
|
1 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Race (NIH/OMB)
Spinal cord injured individuals · Unknown or Not Reported
|
0 Participants
n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Region of Enrollment
United States · Uninjured controls
|
67 Participants
n=81 Participants
|
|
Region of Enrollment
United States · Spinal cord injury individuals
|
14 Participants
n=81 Participants
|
|
Population
Uninjured controls
|
67 Participants
n=81 Participants
|
|
Population
Spinal cord injury individuals
|
14 Participants
n=81 Participants
|
|
Body Mass Index
Uninjured controls
|
23.1 kg/m^2
STANDARD_DEVIATION 2.9 • n=67 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
|
Body Mass Index
Spinal cord injury individuals
|
23.6 kg/m^2
STANDARD_DEVIATION 2.5 • n=14 Participants • The overall number (81) includes uninjured controls (67) and spinal cord injured individuals (14).
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 81 participants include 67 controls and 14 SCI across 2 protocols. Thus, most individuals completed only a subset of the total physiological maneuvers. After quality control, unusable data was discarded and outcome measures are reported only in the subgroup of individuals (# of participants analyzed for each group included for each test below) analyzed with appropriate data. Reasons for unusable data: spasticity (SCI), unable to complete certain physiological stimuli, motion artifacts.
Concentration of hemoglobin content assessed in response to several physical maneuvers (isometric handgrip exercise, cold pressor test, nitroglycerin, reactive hyperemia, leg dependency). Results are reported in tibial total hemoglobin content (μM). To date there are no absolute established values of tibial bone hemoglobin content and thus an absolute range (minimum and maximum) cannot be provided.
Outcome measures
| Measure |
Laboratory Based Assessments
n=81 Participants
The current study has no arms; it is a cross-sectional assessment where all participants will undergo the same procedures.
Laboratory based assessments: physical maneuvers to assess physiological responses in bone blood flow
|
|---|---|
|
Tibial Blood Perfusion
Spinal Cord Injury: Isometric handgrip exercise - maximum tibial total hemoglobin (N=14 analyzed)
|
0.54 μM (concentration)
Standard Deviation 1.66
|
|
Tibial Blood Perfusion
Uninjured controls: Isometric handgrip exercise - maximum tibial total hemoglobin (N=13 analyzed)
|
-1.47 μM (concentration)
Standard Deviation 3.86
|
|
Tibial Blood Perfusion
Uninjured controls: Cold pressor test - maximum tibial total hemoglobin (N=13 analyzed)
|
0.43 μM (concentration)
Standard Deviation 2.18
|
|
Tibial Blood Perfusion
Uninjured controls: Nitroglycerin response - maximum tibial total hemoglobin(N=16 analyzed)
|
2.08 μM (concentration)
Standard Deviation 0.88
|
|
Tibial Blood Perfusion
Uninjured controls: Reactive hyperemia - maximum tibial total hemoglobin (N=11 analyzed)
|
3.42 μM (concentration)
Standard Deviation 2.06
|
|
Tibial Blood Perfusion
Uninjured controls: Leg dependency - tibial total hemoglobin (N=14 analyzed)
|
1.55 μM (concentration)
Standard Deviation 8.55
|
Adverse Events
Laboratory Based Assessments
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. Adina E. Draghici
Spaulding Rehabilitation Hospital Cambridge
Phone: 617-758-5508
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place