Trial Outcomes & Findings for Exercise Mode and Acute Bone Resorption (NCT NCT04815824)
NCT ID: NCT04815824
Last Updated: 2025-07-20
Results Overview
CTX is a blood marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Before to up to 48 hours after acute exercise bout
Results posted on
2025-07-20
Participant Flow
Participant milestones
| Measure |
Stationary Cycling First, Then Treadmill Walking
All participants will complete one, 60-minute bout of stationary cycling. Approximately one week later, participants will complete a 60-minute bout of treadmill walking.
|
Treadmill Walking First, Then Stationary Cycling
All participants will complete one, 60-minute bout of treadmill walking. Approximately one week later, participants will complete a 60-minute bout of stationary cycling.
|
|---|---|---|
|
First Intervention (60 Minutes)
STARTED
|
5
|
4
|
|
First Intervention (60 Minutes)
COMPLETED
|
5
|
4
|
|
First Intervention (60 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
5
|
4
|
|
Washout (1 Week)
COMPLETED
|
5
|
4
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (60 Minutes)
STARTED
|
5
|
4
|
|
Second Intervention (60 Minutes)
COMPLETED
|
5
|
4
|
|
Second Intervention (60 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Mode and Acute Bone Resorption
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
All participants complete both a stationary cycling and a treadmill walking exercise bout, but the order was randomized.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
|
Cardiorespiratory Fitness (VO2peak)
|
25.8 mL/kg/min
STANDARD_DEVIATION 3.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Before to up to 48 hours after acute exercise boutCTX is a blood marker of bone resorption. Reference range is 0.1-0.8 ng/mL with lower concentrations suggesting less bone resorption.
Outcome measures
| Measure |
Stationary Cycling
n=9 Participants
All participants will complete one, 60-minute bout of stationary cycling
Exercise Mode: Stationary cycling or treadmill walking
|
Treadmill Walking
n=9 Participants
All participants will complete one, 60-minute bout of treadmill walking
Exercise Mode: Stationary cycling or treadmill walking
|
|---|---|---|
|
C-telopeptide of Type I Collagen (CTX) Change
|
0.09 ng/mL
Standard Error 0.06
|
0.08 ng/mL
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Before to up to 48 hours after acute exercise boutPINP is a blood marker of bone formation. Reference range is 19-80 ng/mL with lower concentrations suggesting less bone formation.
Outcome measures
| Measure |
Stationary Cycling
n=9 Participants
All participants will complete one, 60-minute bout of stationary cycling
Exercise Mode: Stationary cycling or treadmill walking
|
Treadmill Walking
n=9 Participants
All participants will complete one, 60-minute bout of treadmill walking
Exercise Mode: Stationary cycling or treadmill walking
|
|---|---|---|
|
Procollagen of Type I N-terminal Propeptide (P1NP) Change
|
-3.1 ng/mL
Standard Error 7.8
|
-1.5 ng/mL
Standard Error 7.1
|
Adverse Events
Stationary Cycling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treadmill Walking
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. Sarah Wherry
VA Eastern Colorado Health Care System
Phone: 303-704-8054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place