Trial Outcomes & Findings for Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics. (NCT NCT01440634)

Last Updated: 2015-12-29

Results Overview

Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked.

Recruitment status

COMPLETED

Study phase

Target enrollment

347 participants

Primary outcome timeframe

6 months

Results posted on

2015-12-29

Participant Flow

Patients were recruited at community centers. Enrollment was performed between february 2008 and June 2011.

Patients that denied to be randomized and/or to follow the schedule for the research procedures was excluded of the study.

Participant milestones

Participant milestones
Measure	Supervised Exercise It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.	Standard of Care Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
Cross Sectional Phase STARTED	0	347
Cross Sectional Phase COMPLETED	0	347
Cross Sectional Phase NOT COMPLETED	0	0
Randomization Phase STARTED	30	24
Randomization Phase COMPLETED	24	14
Randomization Phase NOT COMPLETED	6	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supervised Exercise n=24 Participants It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.	Standard of Care n=14 Participants Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.	Total n=38 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Age, Continuous	75 years n=5 Participants	79.5 years INTER_QUARTILE_RANGE 11.08 • n=7 Participants	79.5 years INTER_QUARTILE_RANGE 11.08 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	14 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Supervised Exercise n=30 Participants It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.	Standard of Care n=24 Participants Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
Effect of an Exercise Intervention on Walking Ability (Functional Outcome)	301.4 meters Standard Deviation 140.3	185.1 meters Standard Deviation 164.1

Adverse Events

Supervised Exercise

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Supervised Exercise n=30 participants at risk It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.	Standard of Care n=24 participants at risk Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
General disorders Death	3.3% 1/30 • Number of events 1	0.00% 0/24

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos H Timaran

UT Southwestern Medical Center

Phone: 2146450533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place