Trial Outcomes & Findings for Polestriding Versus Walking for Subjects With Poor Leg Circulation (NCT NCT00719355)

NCT ID: NCT00719355

Last Updated: 2013-02-12

Results Overview

Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 146 participants
• Primary outcome timeframe: Baseline and 24 weeks
• Results posted on: 2013-02-12

Participant Flow

Patients were recruited at University of Illinois at Chicago, the Edward Hines Jr., VA Hospital, through radio and print advertising. 146 patients were enrolled in the study and 103 were randomized.

Patients were screened prior to randomization. Patients were disqualified from the study due to coronary arterial disease, they changed their mind, other medical reasons or it was found that they did not have periphaeral arterial disease.

Participant milestones

Measure	Walking With Poles Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group Patients exercised for 24 weeks as part of a traditional walking training group.
Overall Study STARTED	51	52
Overall Study Completed 6 Weeks	49	48
Overall Study Completed 12 Weeks	43	46
Overall Study Completed 24 Weeks	34	43
Overall Study Completed 32 Weeks	33	39
Overall Study COMPLETED	33	39
Overall Study NOT COMPLETED	18	13

Reasons for withdrawal

Measure	Walking With Poles Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group Patients exercised for 24 weeks as part of a traditional walking training group.
Overall Study Death	0	1
Overall Study Medical	14	5
Overall Study Compliance	4	6
Overall Study Moved	0	1

Baseline Characteristics

Polestriding Versus Walking for Subjects With Poor Leg Circulation

Baseline characteristics by cohort

Measure	Walking With Poles n=51 Participants Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group n=52 Participants Patients exercised for 24 weeks as part of a traditional walking training group.	Total n=103 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	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Age Continuous	71.4 years STANDARD_DEVIATION 9.1 • n=5 Participants	68.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	69.7 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	52 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.

Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).

Outcome measures

Measure	Walking With Poles n=49 Participants Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group n=48 Participants Patients exercised for 24 weeks as part of a traditional walking training group.
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test	15.15 minutes Standard Deviation 12.31	21.40 minutes Standard Deviation 16.46

SECONDARY outcome

Timeframe: At 24 weeks

Population: Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.

Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.

Outcome measures

Measure	Walking With Poles n=49 Participants Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group n=48 Participants Patients exercised for 24 weeks as part of a traditional walking training group.
Onset of Claudication Pain During Constant Work Rate Treadmill Test	9.3 minutes Standard Deviation 12.1	6.8 minutes Standard Deviation 4.8

Adverse Events

Walking With Poles

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Traditional Walking Group

Serious events: 6 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Walking With Poles n=52 participants at risk；n=51 participants at risk Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group n=51 participants at risk；n=52 participants at risk Patients exercised for 24 weeks as part of a traditional walking training group.
Vascular disorders Death	0.00% 0/51 • Adverse events were collected for 32 weeks (the duration of the study).	1.9% 1/52 • Number of events 1 • Adverse events were collected for 32 weeks (the duration of the study).
Respiratory, thoracic and mediastinal disorders Hospitalization respiratory	3.9% 2/51 • Number of events 2 • Adverse events were collected for 32 weeks (the duration of the study).	1.9% 1/52 • Number of events 1 • Adverse events were collected for 32 weeks (the duration of the study).
Renal and urinary disorders Hospitalization renal disease	0.00% 0/51 • Adverse events were collected for 32 weeks (the duration of the study).	1.9% 1/52 • Number of events 1 • Adverse events were collected for 32 weeks (the duration of the study).
Cardiac disorders Hospitalization cardiac related	5.9% 3/51 • Number of events 3 • Adverse events were collected for 32 weeks (the duration of the study).	1.9% 1/52 • Number of events 1 • Adverse events were collected for 32 weeks (the duration of the study).
Gastrointestinal disorders Hospitalization bowel obstruction	0.00% 0/51 • Adverse events were collected for 32 weeks (the duration of the study).	1.9% 1/52 • Number of events 1 • Adverse events were collected for 32 weeks (the duration of the study).
Endocrine disorders Hospitalization low blood sugar	0.00% 0/51 • Adverse events were collected for 32 weeks (the duration of the study).	1.9% 1/52 • Number of events 1 • Adverse events were collected for 32 weeks (the duration of the study).

Other adverse events

Measure	Walking With Poles n=52 participants at risk；n=51 participants at risk Patients exercised using walking poles, 3 times weekly for 24 weeks.	Traditional Walking Group n=51 participants at risk；n=52 participants at risk Patients exercised for 24 weeks as part of a traditional walking training group.
Social circumstances Fall	3.8% 2/52 • Number of events 2 • Adverse events were collected for 32 weeks (the duration of the study).	5.9% 3/51 • Number of events 3 • Adverse events were collected for 32 weeks (the duration of the study).

Additional Information

Eileen G. Collins PhD, RN

University of Illinois at Chicago

Phone: 312-413-5621

Email: ecollins@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place