Peripheral Arterial Disease
Conditions
Brief summary
The purpose of this study is to compare the effects of polestriding (walking with poles) and traditional walking on physical endurance in subjects with poor circulation in their legs. Another goal is to evaluate the effectiveness of a walking program in increasing the amount of oxygen in the calf muscles and therefore improving overall physical activity and quality of life.
Detailed description
Peripheral Arterial Disease (PAD/PVD) is caused by decreased blood flow to the legs. The most common symptom is intermittent claudication pain during walking that is relieved by rest. Walking is the primary treatment prescribed for PAD rehabilitation. Polestriding uses muscles of the upper and lower body in a continuous movement. Walking with poles increases stride length, cadence and walking speed and decreases ground reaction forces on the joints. Subjects in this study will participate in a walking program with or without poles. Dr. Collins' research focuses on physical activity interventions to improve the functional status of persons with chronic illness. Several rehabilitation studies have tested the efficacy of walking exercise for patients with PAD. Studies on polestriding indicate that it may be superior to traditional walking, but these two methods have never been compared. Approximately 30% of patients with coronary artery disease have PAD as their only symptom. As the population ages and more people are affected by this debilitating condition, nurse-initiated rehabilitative therapies, such as polestriding, need to be explored. The consent form explains the purpose of the study in addition to the procedures, risks, benefits, options, confidentiality, costs, and compensation. Participants are also asked to sign a HIPPA authorization.
Interventions
BEHAVIORALWalking with poles
Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
BEHAVIORALWalking exercise
Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
Sponsors
National Institute of Nursing Research (NINR)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Peripheral Vascular Disease * Cramping/Claudication Pain in legs while walking * Ankle Brachial Index (measure of circulation by doppler) .90 or less
Exclusion criteria
* Ulcers or sores on feet or legs * Unable to walk or confined to a wheelchair * Amputations or severe arthritis pain in shoulders, knees, or hips * Medical conditions which would exclude subject from participating in an exercise program * Vascular Surgery within the last six months, or planning vascular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test | Baseline and 24 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Claudication Pain During Constant Work Rate Treadmill Test | At 24 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Walking With Poles Patients exercised using walking poles, 3 times weekly for 24 weeks. | 51 |
| Traditional Walking Group Patients exercised for 24 weeks as part of a traditional walking training group. | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Compliance | 4 | 6 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Medical | 14 | 5 |
| Overall Study | Moved | 0 | 1 |
Baseline characteristics
| Characteristic | Traditional Walking Group | Walking With Poles | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 34 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 17 Participants | 39 Participants |
| Age Continuous | 68.0 years STANDARD_DEVIATION 8.5 | 71.4 years STANDARD_DEVIATION 9.1 | 69.7 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 52 participants | 51 participants | 103 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 49 Participants | 47 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 52 | 3 / 51 |
| serious Total, serious adverse events | 4 / 51 | 6 / 52 |
Outcome results
Primary
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test
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).
Time frame: Baseline and 24 weeks
Population: Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking With Poles | Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test | 15.15 minutes | Standard Deviation 12.31 |
| Traditional Walking Group | Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test | 21.40 minutes | Standard Deviation 16.46 |
Comparison: Observed power for our primary analysis was 0.64.p-value: 0.033ANCOVA
Secondary
Onset of Claudication Pain During Constant Work Rate 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.
Time frame: At 24 weeks
Population: Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking With Poles | Onset of Claudication Pain During Constant Work Rate Treadmill Test | 9.3 minutes | Standard Deviation 12.1 |
| Traditional Walking Group | Onset of Claudication Pain During Constant Work Rate Treadmill Test | 6.8 minutes | Standard Deviation 4.8 |
p-value: 0.109ANCOVA