Peripheral Arterial DiseasePADNCT02022423
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
A study testing Telephone counseling and Internet-based walking program in people with Peripheral Arterial Disease, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
Peripheral arterial disease (PAD) is a significant vascular condition affecting millions of adults. Exercise such as walking is highly effective for reducing PAD symptoms such as claudication (pain with walking) and improving physical function. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Telephone counseling and Internet-based walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40
- Diagnosis of PAD due to atherosclerosis, documented by 1 or more of the following:
- documented ankle brachial index (ABI) ≤ 0.9 in at least one leg
- toe brachial index ≤ .70 for participants with an ABI > 1.3
- documented arterial disease by MRI, CT or angiogram Ability to walk at least 150 feet without the assistance of a cane or walker. Are sedentary (defined as < 150 minutes per week of physical activity). Able to obtain medical clearance from a primary care provider, cardiologist, vascular specialist, endocrinologist, nurse practitioner, or physician assistant.
- Competent to give informed consent. Have regular access to a computer with an Internet connection that allows software downloading.
- Be a regular email user (check email at least once a week).
Who cannot join
- PAD due to non-atherosclerotic causes such as trauma, entrapment syndromes or congenital anomalies.
- No primary provider, or cardiologist or vascular provider Life expectancy of under 1-year Co-morbidities which limit physical activity to a severe degree (defined as the inability to walk a grocery store aisle unassisted) Signs of critical limb ischemia and/or planned peripheral revascularization in the next 12-months
- A diagnoses of any of the following cardiovascular events in the past 3 months:
- stroke/transient ischemic attack
- myocardial infarction
- unstable angina
Show all 11Show fewer
- percutaneous coronary intervention
- coronary bypass graft surgery A diagnoses of any of the following cardiovascular conditions
- severe valve disease untreated
- complex arrhythmia untreated
- New York Heart Association class III-IV heart failure Current substance abuse, or significant psychiatric disorder, or dementia which limits the participant's ability to follow the study protocol Pregnancy Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48106
University of Alabama Birmingham
Birmingham, Alabama, 35294
About this study
Peripheral arterial disease (PAD) is a significant vascular condition affecting millions of adults. Exercise such as walking is highly effective for reducing PAD symptoms such as claudication (pain with walking) and improving physical function. The trial examines the efficacy of a internet-delivered walking program for patients with PAD. Comparator groups including telephone counselling, the combination of internet-delivered walking program + telephone counseling, or usual care. The primary outcome of interest is maximal walking distance.
Read the detailed description
With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality. While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals. Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD). Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD. Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group. The Internet-based walking program has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes. There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients. Patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Telephone counseling, Internet-based walking program
- Keywords
- peripheral arterial disease, walking, eHealth, telehealth
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone counselingBehavioural
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Internet-based walking programBehavioural
Four-month Internet-based walking program consisting of weekly step count goals
| Study group | Role | What they receive |
|---|---|---|
| Telephone Counseling | Active comparator | Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs Receives: Behavioral: Telephone counseling |
| Internet-based walking program | Experimental | Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation. Receives: Behavioral: Internet-based walking program |
| Telephone counseling and Internet-based walking program | Experimental | Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs plus weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation. Receives: Behavioral: Telephone counseling; Behavioral: Internet-based walking program |
| Usual Care | No intervention | Subjects will continue with their health care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal walking distance
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Measured: Baseline to 4 months
Change in PAD-specific health-related quality of life
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Measured: Baseline to 4 months
Change in general health-related quality of life
measured using the EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable. The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
Measured: Baseline to 4 months
Change in global health-related quality of life
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric. A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
Measured: Baseline to 4 months
Secondary outcomes (5)
Change in pain-free walking distance
measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
Measured: Baseline to 4 months
Change in maximal walking distance
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Measured: Baseline to 12 months
Change in PAD-specific health-related quality of life
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Measured: Baseline to 12 months
Change in general health-related quality of life
measured using EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable. The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
Measured: Baseline to 12 months
Change in global health-related quality of life
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric. A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four groups are included in this study
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Anne Jackson, University of Alabama at Birmingham
- Investigators
- Elizabeth A. Jackson, MD MPH FACC, Principal investigator, University of Alabama at Birmingahm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022423
- Sponsor's protocol ID
- NCT02022423
- Acronym
- PAD
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2013
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar AM, Lyden AK, Carlozzi NE, Sen A, Richardson CR, Jackson EA. The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease. Contemp Clin Trials. 2018 Apr;67:23-30. doi: 10.1016/j.cct.2017.12.009. Epub 2017 Dec 21.
PubMed 29274894Jones R, Enogela EM, Zumbro EL, Soukhamneut P, Richardson CR, Buford TW, Jackson EA. Assessment of Frailty Among Older Adults in the Physical Activity Daily Trial. J Appl Gerontol. 2024 Oct;43(10):1428-1437. doi: 10.1177/07334648241244690. Epub 2024 Apr 24.
PubMed 38655762
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02022423
- Acronym / sponsor ID
- PAD / NCT02022423
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, walking, eHealth, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral arterial disease (PAD) is a significant vascular condition affecting millions of adults. Exercise such as walking is highly effective for reducing PAD symptoms such as claudication (pain with walking) and improving physical function. The trial examines the efficacy of a internet-delivered walking program for patients with PAD. Comparator groups including telephone counselling, the combination of internet-delivered walking program + telephone counseling, or usual care. The primary outcome of interest is maximal walking distance.
Detailed description
With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality. While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals. Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD). Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD. Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group. The Internet-based walking program has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes. There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients. Patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four groups are included in this study
| Arm | Type | Receives |
|---|---|---|
| Telephone Counseling | Active comparator | Behavioral: Telephone counselingWeekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs |
| Internet-based walking program | Experimental | Behavioral: Internet-based walking programWeekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation. |
| Telephone counseling and Internet-based walking program | Experimental | Behavioral: Telephone counseling, Behavioral: Internet-based walking programWeekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs plus weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation. |
| Usual Care | No intervention | –Subjects will continue with their health care as usual |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 40
- documented ankle brachial index (ABI) ≤ 0.9 in at least one leg
- toe brachial index ≤ .70 for participants with an ABI > 1.3
- documented arterial disease by MRI, CT or angiogram Ability to walk at least 150 feet without the assistance of a cane or walker. Are sedentary (defined as < 150 minutes per week of physical activity). Able to obtain medical clearance from a primary care provider, cardiologist, vascular specialist, endocrinologist, nurse practitioner, or physician assistant.
- Competent to give informed consent. Have regular access to a computer with an Internet connection that allows software downloading.
Key exclusion criteria (11 listed)
- PAD due to non-atherosclerotic causes such as trauma, entrapment syndromes or congenital anomalies.
- No primary provider, or cardiologist or vascular provider Life expectancy of under 1-year Co-morbidities which limit physical activity to a severe degree (defined as the inability to walk a grocery store aisle unassisted) Signs of critical limb ischemia and/or planned peripheral revascularization in the next 12-months
- stroke/transient ischemic attack
- myocardial infarction
- unstable angina
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 |
|---|---|---|
| Telephone counseling4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence | Behavioural | Telephone Counseling, Telephone counseling and Internet-based walking program |
| Internet-based walking programFour-month Internet-based walking program consisting of weekly step count goals | Behavioural | Internet-based walking program, Telephone counseling and Internet-based walking program |
Primary outcome
Change in maximal walking distance
Time frame: Baseline to 4 months
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Change in PAD-specific health-related quality of life
Time frame: Baseline to 4 months
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Change in general health-related quality of life
Time frame: Baseline to 4 months
measured using the EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable. The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
Change in global health-related quality of life
Time frame: Baseline to 4 months
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric. A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
5 secondary outcomes
Change in pain-free walking distance
Time frame: Baseline to 4 months
Change in maximal walking distance
Time frame: Baseline to 12 months
Change in PAD-specific health-related quality of life
Time frame: Baseline to 12 months
Change in general health-related quality of life
Time frame: Baseline to 12 months
Change in global health-related quality of life
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Background: PubMed 29274894Kumar AM, Lyden AK, Carlozzi NE, Sen A, Richardson CR, Jackson EA. The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease. Contemp Clin Trials. 2018 Apr;67:23-30. doi: 10.1016/j.cct.2017.12.009. Epub 2017 Dec 21.
- Derived from this study: PubMed 38655762Jones R, Enogela EM, Zumbro EL, Soukhamneut P, Richardson CR, Buford TW, Jackson EA. Assessment of Frailty Among Older Adults in the Physical Activity Daily Trial. J Appl Gerontol. 2024 Oct;43(10):1428-1437. doi: 10.1177/07334648241244690. Epub 2024 Apr 24.
- Individual participant dataSharing planned: No
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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.
Elizabeth A. Jackson, MD MPH FACC principal investigator
University of Alabama at Birmingahm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone counseling and Internet-based walking program in people with Peripheral Arterial Disease, run by University of Alabama at Birmingham at 2 sites 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 7 inclusion and 11 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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 maximal walking distance (time frame: Baseline to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022423, which also lists 2 linked publications.
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 21 Dec 2021.