Peripheral Artery DiseaseEASY FITNCT03099369
Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease
A study testing Daily Step-based Exercise, Symptom-based Exercise and Fitbit Fitness Monitor in people with Peripheral Artery Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Daily Step-based Exercise, Symptom-based Exercise and Fitbit Fitness Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years or older
- Diagnosis of lower extremity PAD based on at least 1 of the following criteria:
- Ankle-brachial index (ABI) of 0.9 or less in one or both legs
- Invasive angiography demonstrating obstructive lower extremity artery disease
- Endovascular or surgical revascularization of lower extremity artery
- Symptomatic lower extremity PAD, characterized by 1 of the following:
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- Fontaine Stage IIa: intermittent claudication after walking > 200 meters
- Fontaine Stage IIb: intermittent claudication after walking < 200 meters
- 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
Who cannot join
- Wheelchair bound
- Use of a walking aid (ie. cane, crutches, walker, motorized chair)
- Below or above the knee amputation
- Leg pain at rest
- Acute or critical limb ischemia
- Ischemic ulceration or gangrene
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- Diabetes mellitus complicated by neuropathy
- Walking impairment due to another cause than PAD
- Ongoing evaluation for coronary artery disease (ie. awaiting a stress test or cardiac catheterization)
- Active coronary artery disease requiring the initiation or uptitration of an anti-anginal medication
- Angina with Canadian Cardiovascular Society (CCS) class 3-4 symptoms
- Myocardial infarction in the last 3 months
- Active congestive heart failure requiring the initiation or uptitration of diuretic therapy
- Congestive heart failure with New York Heart Association (NYHA) class 3-4 symptoms
- Active arrhythmia requiring the initiation or uptitration of an anti-arrhythmic medication
- Severe valve disease
- Active cancer or malignancy (not in remission)
- End-stage renal disease requiring hemodialysis or peritoneal dialysis
- Advanced liver disease, defined as cirrhosis
- Thyroid disease with abnormal TSH in the past 3 months
- Severe cognitive dysfunction, defined as dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27514
About this study
Official title: The Effectiveness of Daily Step-based Exercise Therapy Using Fitness Monitors for Peripheral Artery Disease: The EASY FIT Trial
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.
Read the detailed description
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Daily Step-based Exercise, Symptom-based Exercise, Fitbit Fitness Monitor
- Keywords
- Peripheral Artery Disease, Peripheral Arterial Disease, Exercise, Step Count, Fitness Monitor, Mobile Health, Walking Ability, Quality of Life
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Step-based ExerciseBehavioural
A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.
Symptom-based ExerciseBehavioural
A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.
Fitbit Fitness MonitorOther
Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
| Study group | Role | What they receive |
|---|---|---|
| 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.
* 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. Receives: Behavioral: Daily Step-based Exercise; Other: Fitbit Fitness Monitor |
| 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).
* 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. Receives: Behavioral: Symptom-based Exercise; Other: Fitbit Fitness Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 3
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- David W Lee, MD, Principal investigator, University of North CarolinaPrashant Kaul, MD, Principal investigator, University of North CarolinaGeorge A Stouffer, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099369
- Sponsor's protocol ID
- 16-3427
- Acronym
- EASY FIT
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2017
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Daily Step-based Exercise Therapy Using Fitness Monitors for Peripheral Artery Disease: The EASY FIT Trial
- ClinicalTrials.gov ID
- NCT03099369
- Acronym / sponsor ID
- EASY FIT / 16-3427
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, Peripheral Arterial Disease, Exercise, Step Count, Fitness Monitor, Mobile Health, Walking Ability, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 12 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Step-based Exercise Group | Experimental | Behavioral: Daily Step-based Exercise, Other: Fitbit Fitness MonitorThe 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. |
| Symptom-based Exercise Group | Active comparator | Behavioral: Symptom-based Exercise, Other: Fitbit Fitness MonitorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- Wheelchair bound
- Use of a walking aid (ie. cane, crutches, walker, motorized chair)
- Below or above the knee amputation
- Leg pain at rest
- Acute or critical limb ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Step-based ExerciseA 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day. | Behavioural | Daily Step-based Exercise Group |
| Symptom-based ExerciseA 12-week symptom-based exercise prescription adapted from clinical practice guidelines. | Behavioural | Symptom-based Exercise Group |
| Fitbit Fitness MonitorUsed by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only | Other | Daily Step-based Exercise Group, Symptom-based Exercise Group |
Primary outcome
Change in the Mean Daily Walking Distance Over 7 Consecutive Days
Time frame: Baseline, Month 3
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.
2 secondary outcomes
Change in the Peripheral Artery Questionnaire (PAQ) Summary Score
Time frame: Baseline, Month 3
Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Lee, MD principal investigator
University of North Carolina
Prashant Kaul, MD principal investigator
University of North Carolina
George A Stouffer, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Step-based Exercise, Symptom-based Exercise and Fitbit Fitness Monitor in people with Peripheral Artery Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mean Daily Walking Distance Over 7 Consecutive Days (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.