An interventional study of Daily Step-based Exercise and Symptom-based Exercise in Peripheral Artery Disease, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
Peripheral artery disease (PAD) is caused by blockages in the leg arteries. PAD limits patients' walking ability and quality of life. For patients with PAD, home exercise programs can improve walking ability and quality of life. In many patient populations, walking more than 5,000 steps a day is associated with better health. Currently, the benefit of walking more than 5,000 steps a day in patients with PAD has not been well studied.
The purpose of this clinical trial is to compare two different home exercise programs in patients with PAD: walking at least 5,000 steps a day with the help of fitness monitors vs. walking 45 consecutive minutes for 3 to 5 days a week (a common exercise prescription for PAD). This study has the potential to demonstrate that, with the help of fitness monitors, walking at least 5,000 steps a day can improve walking ability and quality of life for patients with PAD.
Peripheral artery disease (PAD) is the third leading cause of cardiovascular morbidity, following coronary artery disease and stroke. Symptoms of PAD include claudication, decreased exercise capacity, progressive functional impairment, and decreased quality of life. Structured exercise therapy is a cornerstone of treating symptomatic PAD. Guidelines recommend a symptom-based exercise program that uses claudication to moderate walking sessions.
Home exercise programs have demonstrated efficacy in improving walking ability and quality of life for symptomatic PAD patients. In the general population and patients with certain chronic diseases, walking more than 5,000 steps a day has been associated with better health. The efficacy of walking more than 5,000 steps a day has not been well studied in symptomatic PAD patients.
The EASY FIT Trial is a single-center prospective randomized controlled trial comparing the effectiveness of a daily step-based exercise program (walking at least 5,000 steps a day) vs. a guideline-recommended symptom-based exercise program (walking 45 consecutive minutes for 3 to 5 days a week), on improving walking ability and quality of life in patients with symptomatic PAD. The study will enroll and randomize 40 patients with symptomatic PAD (20 to each exercise program).The results of this study have the potential to create an effective, safe, feasible, and sustainable exercise program that can help PAD patients have greater walking ability and better quality of life.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 20 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
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Diagnosis of lower extremity PAD based on at least 1 of the following criteria:
Symptomatic lower extremity PAD, characterized by 1 of the following:
Exclusion Criteria:
The experimental group will receive the following 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day (based on evidence that at least 5,000 a day is associated with better health). The Fitbit Fitness Monitor used for tracking. * Week 1: walk at least 3,000 steps every day. * Week 2: walk at least 3,500 steps every day. * Week 3: walk at least 4,000 steps every day. * Week 4: walk at least 4,500 steps every day. * Weeks 5-12: walk at least 5,000 steps every day.
Behavioral: Daily Step-based Exercise · Other: Fitbit Fitness Monitor
The active comparator group (ie. control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines). * Walk on a flat surface at a constant speed until there is mild to moderate pain * Rest until the pain has completely ceased * Resume walking at the same speed * Increase the speed when you can walk 8 minutes without stopping for leg symptoms * Continue this exercise routine for 45 consecutive minutes, 3 to 5 days a week.
Behavioral: Symptom-based Exercise · Other: Fitbit Fitness Monitor
A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.
A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.
Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
Change in the Mean Daily Walking Distance Over 7 Consecutive Days
At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.
Time frame: Baseline, Month 3
Change in the Peripheral Artery Questionnaire (PAQ) Summary Score
At baseline, both groups will be asked to complete the Peripheral Artery Questionnaire (PAQ), which is a quality-of-life survey with a summary score ranging from 0 to 100 (with 100 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the PAQ again. The change in the summary score at 3 months will the secondary outcome.
Time frame: Baseline, Month 3
Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score
At baseline, both groups will be asked to complete the Vascular Quality of Life Questionnaire (VascuQol), which is a quality-of-life survey with a summary score ranging from 25 to 175 (with 175 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the VascuQol survey again. The change in the summary score at 3 months will the secondary outcome.
Time frame: Baseline, Month 3
| Milestone | Daily Step-based Exercise Group | Symptom-based Exercise Group |
|---|---|---|
| Started | 11 | 9 |
| Completed | 5 | 5 |
| Not completed | 6 | 4 |
At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.
| steps | Daily Step-based Exercise Group | Symptom-based Exercise Group |
|---|---|---|
| Change in the Mean Daily Walking Distance Over 7 Consecutive Days | 754.2 ± 1621.7 | -1160 ± 2963.2 |
At baseline, both groups will be asked to complete the Peripheral Artery Questionnaire (PAQ), which is a quality-of-life survey with a summary score ranging from 0 to 100 (with 100 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the PAQ again. The change in the summary score at 3 months will the secondary outcome.
No measurements were reported for this outcome.
At baseline, both groups will be asked to complete the Vascular Quality of Life Questionnaire (VascuQol), which is a quality-of-life survey with a summary score ranging from 25 to 175 (with 175 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the VascuQol survey again. The change in the summary score at 3 months will the secondary outcome.
No measurements were reported for this outcome.
Collected over Adverse events were collected based on participant chart review during the baseline assessment period (1 week), the 12-week intervention period, and the final assessment period (1 week), for a total of approximately 14 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daily Step-based Exercise Group | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Symptom-based Exercise Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Daily Step-based Exercise Group | Symptom-based Exercise Group | Total |
|---|---|---|---|
| Mean | 62.6 ± 8.5 | 58.6 ± 16.5 | 60.6 ± 12.6 |
| Sex: Female, Male(Participants) | Daily Step-based Exercise Group | Symptom-based Exercise Group | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 5 | 4 | 9 |
| Race and Ethnicity Not Collected(Participants) | Daily Step-based Exercise Group | Symptom-based Exercise Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Daily Step-based Exercise Group | Symptom-based Exercise Group | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
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University of North Carolina, Chapel Hill