Trial Outcomes & Findings for Blood Flow, Muscle Regeneration and Sarcopenia (NCT NCT01035060)
NCT ID: NCT01035060
Last Updated: 2013-01-09
Results Overview
Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.
Recruitment status
COMPLETED
Target enrollment
68 participants
Primary outcome timeframe
Baseline, 2 days post-injury, 7 days post-injury
Results posted on
2013-01-09
Participant Flow
From September 2010 through December 2011, community-dwelling persons were recruited to participate through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.
Participant milestones
| Measure |
Older Adults
Persons aged ≥ 70 years
|
Young Adults
Persons aged 18-30 years
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
29
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
24
|
14
|
Reasons for withdrawal
| Measure |
Older Adults
Persons aged ≥ 70 years
|
Young Adults
Persons aged 18-30 years
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
7
|
|
Overall Study
Did not quality after 2nd screening
|
14
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Blood Flow, Muscle Regeneration and Sarcopenia
Baseline characteristics by cohort
| Measure |
Older Adults
n=39 Participants
|
Young Adults
n=29 Participants
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
29 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 days post-injury, 7 days post-injuryChange in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.
Outcome measures
| Measure |
Older Adults
n=15 Participants
Age \> 70 years
|
Young Adults
n=15 Participants
Age 18-35 years
|
|---|---|---|
|
Muscle Satellite Cells
Adjusted Baseline
|
3.2 Number of Pax7+ cells/muscle fiber
Standard Error 0.0
|
3.2 Number of Pax7+ cells/muscle fiber
Standard Error 0.0
|
|
Muscle Satellite Cells
Adjusted 2 days post-injury
|
4.0 Number of Pax7+ cells/muscle fiber
Standard Error .4
|
3.8 Number of Pax7+ cells/muscle fiber
Standard Error 0.4
|
|
Muscle Satellite Cells
Adjusted 7 days post-injury
|
4.0 Number of Pax7+ cells/muscle fiber
Standard Error 0.3
|
3.7 Number of Pax7+ cells/muscle fiber
Standard Error 0.3
|
Adverse Events
Younger Adults
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Older Adults
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Younger Adults
n=29 participants at risk
|
Older Adults
n=39 participants at risk
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/29 • 14 months
Data collected during study visits from September 2010 to December 2011
|
2.6%
1/39 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.00%
0/29 • 14 months
Data collected during study visits from September 2010 to December 2011
|
2.6%
1/39 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
Other adverse events
| Measure |
Younger Adults
n=29 participants at risk
|
Older Adults
n=39 participants at risk
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Skeletal Muscle Soreness
|
0.00%
0/29 • 14 months
Data collected during study visits from September 2010 to December 2011
|
10.3%
4/39 • Number of events 4 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
General disorders
Pain/Bruising
|
13.8%
4/29 • Number of events 5 • 14 months
Data collected during study visits from September 2010 to December 2011
|
2.6%
1/39 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.4%
1/29 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
0.00%
0/39 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
Musculoskeletal and connective tissue disorders
Broken Toe
|
3.4%
1/29 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
0.00%
0/39 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/29 • 14 months
Data collected during study visits from September 2010 to December 2011
|
2.6%
1/39 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
General disorders
Mild swelling
|
3.4%
1/29 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
0.00%
0/39 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/29 • 14 months
Data collected during study visits from September 2010 to December 2011
|
2.6%
1/39 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
|
Skin and subcutaneous tissue disorders
Minor Rash
|
0.00%
0/29 • 14 months
Data collected during study visits from September 2010 to December 2011
|
2.6%
1/39 • Number of events 1 • 14 months
Data collected during study visits from September 2010 to December 2011
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place