Trial · NCT01408901

Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD)

NCT01408901, Not applicable, Completed, Northwestern University; results first posted 2019-12-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD). Trials, record NCT01408901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01408901

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treadmill Exercise and GM-CSF Study to Improving Functioning in Peripheral Artery Disease (PAD)
NCT number: NCT01408901
Status: Completed
Phases: Not applicable
Enrollment: 210 participants, actual
Lead sponsor: Northwestern University
Conditions: Peripheral Arterial Disease
Interventions: Supervised Treadmill Exercise Therapy, Health education sessions (Control), granulocyte macrophage colony stimulating factor (GM-CSF)
First posted: 2011-08-03
Last updated: 2020-01-21
Results first posted: 2019-12-10

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Six-Minute Walk Performance at 12-week Follow-up	change from baseline to week 12	In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.
Secondary	Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up	change from baseline to week 12	The brachial artery is imaged 5 to 9 cm above the antecubital fossa using a linear array vascular ultrasound transducer. Three video sequences are obtained. The first verifies the location and baseline hemodynamic state of the brachial artery. The second begins 20 seconds before cuff inflation and continues for 10 seconds after inflation. The third begins 15 seconds before cuff release and continues for 90 seconds after deflation. Brachial artery FMD is calculated as the percent change in brachial artery diameter at 60 seconds and at 90 seconds after the release of the cuff.
Secondary	Change in Maximal Treadmill Walking Time at 12-week Follow-up	change from baseline to week 12	The Gardner graded treadmill exercise test is the standard, accepted treadmill protocol for measuring change in maximal treadmill walking time in response to interventions among PAD participants. In the Gardner exercise protocol, speed is maintained at 2.0 miles per hour (mph) and treadmill grade increases by 2.0% every two minutes. If patients cannot begin walking at 2.0 mph, treadmill speed is started at 0.50 mph and increased by 0.50 mph every 2 minutes until the participant reaches 2.0 mph, after which the treadmill grade is increased every two minutes.
Secondary	Change in CD34_CD45lo at 12-week Follow-up	change from baseline to week 12	Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software. The outcome is the absolute change in the percentages of cells.
Secondary	Change in CD34_CD45loCD133_ at 12-week Follow-up	change from baseline to week 12	Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software. The outcome is the absolute change in the percentages of cells.
Secondary	Change in CD34_CD45lo_CD31_ at 12-week Follow-up	change from baseline to week 12	Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software. The outcome is the absolute change in the percentages of cells.
Secondary	Change in CD34_CD45lo_CD31_CD133_ at 12-week Follow-up	change from baseline to week 12	Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software. The outcome is the absolute change in the percentages of cells.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Six-Minute Walk Performance at 12-week Follow-up	change from baseline to week 12	Data were imputed for participants who were lost to follow-up or who canceled the visit. Variables used for imputation were age, ankle brachial index, body mass index, sex, race, smoking status, baseline outcome values, leg symptoms, and comorbidities. SAS procedure MI was used to obtain 20 imputed data sets.	meters	MEAN
SECONDARY	Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up	change from baseline to week 12	Data were imputed for participants who were lost to follow-up or who canceled the visit. Variables used for imputation were age, ankle brachial index, body mass index, sex, race, smoking status, baseline outcome values, leg symptoms, and comorbidities. SAS procedure MI was used to obtain 20 imputed data sets.	percent change	MEDIAN
SECONDARY	Change in Maximal Treadmill Walking Time at 12-week Follow-up	change from baseline to week 12	Data were imputed for participants who were lost to follow-up or who canceled the visit. Variables used for imputation were age, ankle brachial index, body mass index, sex, race, smoking status, baseline outcome values, leg symptoms, and comorbidities. SAS procedure MI was used to obtain 20 imputed data sets.	minutes	MEAN
SECONDARY	Change in CD34_CD45lo at 12-week Follow-up	change from baseline to week 12	Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.	percentage of cells	MEAN
SECONDARY	Change in CD34_CD45loCD133_ at 12-week Follow-up	change from baseline to week 12	Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.	percentage of cells	MEAN
SECONDARY	Change in CD34_CD45lo_CD31_ at 12-week Follow-up	change from baseline to week 12	Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.	percentage of cells	MEAN
SECONDARY	Change in CD34_CD45lo_CD31_CD133_ at 12-week Follow-up	change from baseline to week 12	Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.	percentage of cells	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Six-Minute Walk Performance at 12-week Follow-up	A: GM-CSF + Supervised Treadmill Exercise Therapy	22.2	95% Confidence Interval 5.4 to 39.0	meters
Change in Six-Minute Walk Performance at 12-week Follow-up	B: GM-CSF + Attention Control Group	-6.4	95% Confidence Interval -23.0 to 10.1	meters
Change in Six-Minute Walk Performance at 12-week Follow-up	C: Placebo + Supervised Exercise Therapy	28.5	95% Confidence Interval 11.7 to 45.4	meters
Change in Six-Minute Walk Performance at 12-week Follow-up	D: Placebo + Attention Control Group	-5.0	95% Confidence Interval -22.3 to 12.2	meters
Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up	A: GM-CSF + Supervised Treadmill Exercise Therapy	-0.37	Inter-Quartile Range -2.50 to 1.28	percent change
Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up	B: GM-CSF + Attention Control Group	0.10	Inter-Quartile Range -1.49 to 1.18	percent change
Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up	C: Placebo + Supervised Exercise Therapy	0.14	Inter-Quartile Range -1.53 to 1.50	percent change
Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up	D: Placebo + Attention Control Group	-0.72	Inter-Quartile Range -2.02 to 1.64	percent change
Change in Maximal Treadmill Walking Time at 12-week Follow-up	A: GM-CSF + Supervised Treadmill Exercise Therapy	3.5	95% Confidence Interval 2.5 to 4.5	minutes
Change in Maximal Treadmill Walking Time at 12-week Follow-up	B: GM-CSF + Attention Control Group	-0.1	95% Confidence Interval -1.1 to 0.9	minutes

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
6-Week Follow-Up	STARTED	A: GM-CSF + Supervised Treadmill Exercise Therapy	53
6-Week Follow-Up	STARTED	B: GM-CSF + Attention Control Group	53
6-Week Follow-Up	STARTED	C: Placebo + Supervised Exercise Therapy	53
6-Week Follow-Up	STARTED	D: Placebo + Attention Control Group	51
6-Week Follow-Up	COMPLETED	A: GM-CSF + Supervised Treadmill Exercise Therapy	50
6-Week Follow-Up	COMPLETED	B: GM-CSF + Attention Control Group	51
6-Week Follow-Up	COMPLETED	C: Placebo + Supervised Exercise Therapy	50
6-Week Follow-Up	COMPLETED	D: Placebo + Attention Control Group	47
6-Week Follow-Up	NOT COMPLETED	A: GM-CSF + Supervised Treadmill Exercise Therapy	3
6-Week Follow-Up	NOT COMPLETED	B: GM-CSF + Attention Control Group	2

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Aching or soreness in feet	Musculoskeletal and connective tissue disorders	A: GM-CSF + Supervised Treadmill Exercise Therapy	38	53	126
other	Aching or soreness in feet	Musculoskeletal and connective tissue disorders	B: GM-CSF + Attention Control Group	36	53	103
other	Aching or soreness in feet	Musculoskeletal and connective tissue disorders	C: Placebo + Supervised Exercise Therapy	29	53	100
other	Aching or soreness in feet	Musculoskeletal and connective tissue disorders	D: Placebo + Attention Control Group	22	51	61
other	Aching or soreness in thighs	Musculoskeletal and connective tissue disorders	A: GM-CSF + Supervised Treadmill Exercise Therapy	27	53	74
other	Aching or soreness in thighs	Musculoskeletal and connective tissue disorders	B: GM-CSF + Attention Control Group	27	53	53
other	Aching or soreness in thighs	Musculoskeletal and connective tissue disorders	C: Placebo + Supervised Exercise Therapy	26	53	92
other	Aching or soreness in thighs	Musculoskeletal and connective tissue disorders	D: Placebo + Attention Control Group	21	51	53
other	Aching or soreness in lower back	Musculoskeletal and connective tissue disorders	A: GM-CSF + Supervised Treadmill Exercise Therapy	34	53	120
other	Aching or soreness in lower back	Musculoskeletal and connective tissue disorders	B: GM-CSF + Attention Control Group	37	53	115

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	A: GM-CSF + Supervised Treadmill Exercise Therapy	2	53
Total, all-cause mortality	B: GM-CSF + Attention Control Group	1	53
Total, all-cause mortality	C: Placebo + Supervised Exercise Therapy	0	53
Total, all-cause mortality	D: Placebo + Attention Control Group	0	51
Total, other adverse events	A: GM-CSF + Supervised Treadmill Exercise Therapy	52	53
Total, other adverse events	B: GM-CSF + Attention Control Group	49	53
Total, other adverse events	C: Placebo + Supervised Exercise Therapy	50	53
Total, other adverse events	D: Placebo + Attention Control Group	48	51
Total, serious adverse events	A: GM-CSF + Supervised Treadmill Exercise Therapy	17	53
Total, serious adverse events	B: GM-CSF + Attention Control Group	13	53

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24080099	BACKGROUND	PubMed
24982117	BACKGROUND	PubMed
25908727	BACKGROUND	PubMed
26324152	BACKGROUND	PubMed
29141087	RESULT	PubMed
30418100	DERIVED	PubMed
30661439	DERIVED	PubMed
32390569	DERIVED	PubMed
32416309	DERIVED	PubMed
34075780	DERIVED	PubMed

1 to 10 of 13

See all 13 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL107510	PROgenitor Cell Release Plus Exercise To Improve Functional Performance In PAD	MCDERMOTT, MARY MCGRAE	NORTHWESTERN UNIVERSITY AT CHICAGO	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2011 to 2015

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01408901

GET https://conductscience.org/api/trials/v1/NCT01408901/flow?page=2

API reference For AI assistants