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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Step-based Exercise Group | Experimental | 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.
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| Symptom-based Exercise Group | Active Comparator | The active comparator group (ie. control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Step-based Exercise | Behavioral | A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Male or female, age 18 years or older
Diagnosis of lower extremity PAD based on at least 1 of the following criteria:
Symptomatic lower extremity PAD, characterized by 1 of the following:
Have the availability of a suitable environment in which to walk
Have a mobile phone with WiFi and Bluetooth capability
Have the ability to read and speak the English language
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Lee, MD | University of North Carolina | Principal Investigator |
| Prashant Kaul, MD | University of North Carolina | Principal Investigator |
| George A Stouffer, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Step-based Exercise Group | 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 will be used for tracking.
Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
| FG001 | Symptom-based Exercise Group | The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).
Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Step-based Exercise Group | 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 will be used for tracking.
Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data were not collected for 10 participants because of their inability to complete prescribed exercise program or to upload Fitbit data. | Posted | Mean | Standard Deviation | steps | Baseline, Month 3 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daily Step-based Exercise Group | 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 will be used for tracking.
Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Lee, MD | University of North Carolina at Chapel Hill | 347-882-8010 | dave.lee0530@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2017 | Oct 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Symptom-based Exercise | Behavioral | A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. |
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| Fitbit Fitness Monitor | Other | Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
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| 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. | Baseline, Month 3 |
| BG001 | Symptom-based Exercise Group | The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).
Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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.
Daily Step-based Exercise: A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.
Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
| OG001 | Symptom-based Exercise Group | The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).
Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only |
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| Secondary | 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. | None of the participants could be reached to obtain both baseline and endpoint telephone survey data. Therefore, data for this outcome measure are unavailable. | Posted | Baseline, Month 3 |
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| Secondary | 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. | None of the participants could be reached to obtain both baseline and endpoint telephone survey data. Therefore, data for this outcome measure are unavailable. | Posted | Baseline, Month 3 |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Symptom-based Exercise Group | The active comparator group (i.e., control group) will receive the following 12-week symptom-based exercise prescription (adapted from practice guidelines).
Symptom-based Exercise: A 12-week symptom-based exercise prescription adapted from clinical practice guidelines. Fitbit Fitness Monitor: Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only | 0 | 9 | 0 | 9 | 0 | 9 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |