Peripheral Arterial DiseaseTrackPADNCT04947228
Digital Support for Supervised Exercise Therapy in Peripheral Arterial Disease
A study testing trackPAD in people with Peripheral Arterial Disease, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The individual restrictions of daily life for patients with PAD are more important than statistical facts for mortality and morbidity. Intermittent claudication causes a progressive reduction of the pain-free walking distance (PWD) as an expression of a worsening PAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- trackPAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2018to 30 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lower extremity PAD based on (and/or):
- ABI ≤ 0.9 in at least one legs
- Invasive or non-invasive imaging of stenotic lower extremity artery disease
- Endovascular or surgical revascularization of lower extremity artery
- PAD Fontaine Stage IIa/b
- Smartphone with possibility to use TrackPAD: Android ≥ 5.0 or IOS ≥ 11.0
- Written informed consent prior to any study procedures, including a specified follow-up evaluation
- Best-medical treatment in the last 2 months in accordance with standard guidelines
Who cannot join
- Wheelchair bound, use of walking aid or walking impairment due to another cause than PAD
- Below or above knee amputation
- Acute or critical limb ischemia
- PAD Fontaine Stage I or III / IV
- No German knowledge
- Severe cognitive dysfunction
Show all 11Show fewer
- Congestive heart failure with NYHA III-IV symptoms
- Active congestive heart failure requiring the initiation or uptitration of diuretic therapy
- Angina pectoris with CCS class 3-4 symptoms or myocardial infarction or stroke in the last 3 months
- Active arrhythmia requiring the initiation or uptitration of anti-arrhythmic therapy
- Severe valve disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Randomized Controlled Pilot Trial.
The individual restrictions of daily life for patients with PAD are more important than statistical facts for mortality and morbidity. Intermittent claudication causes a progressive reduction of the pain-free walking distance (PWD) as an expression of a worsening PAD. This decrease in physical capability results in a decline of mental health and relevantly reduces the patients' quality of life (QoL).
Supervised exercise therapy (SET) is a cornerstone in the conservative management of intermittent claudication and extends the PWD. Even though SET is easy to practice and highly cost effective, the adherence to perform SET on a regular base is rather low. The underuse of exercise can be partly explained by the lack of institutional resources, but also by both patients' and physicians' lack of interest in exercise.
Read more
Mobile health (mHealth) technologies increase the incentives and provide digital support for patients with PAD on several treatment levels. They might lead to a higher adherence to exercise training and offer new scopes in patient-centered healthcare, but so far studies show opposite results. Because app stores are flooded with health and fitness apps, specific support tools are highly desired by patients with PAD and PAD-specific solutions are missing so far. Based on this background, the investigators developed a smartphone app named TrackPAD to provide PAD-specific support for SET.
The TrackPAD pilot study was designed as a 2-armed randomized controlled trial and included patients with diagnosed and symptomatic PAD. Patients were randomized by the Center for Clinical Studies in Essen using the TENALEA software into 2 groups. The control group included participants with standard care and no further mobile intervention. The intervention group included participants with standard care and additional mHealth-based self-tracking of their physical activity using trackPAD.
- Conditions
- Peripheral Arterial Disease
- Being tested
- trackPAD
- 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.
trackPADDevice
TrackPAD is a smartphone app to provide PAD-specific support for SET
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | in addition to the usual therapy, the patients were given access to the trackPAD app Receives: Device: trackPAD |
| control group | No intervention | patients in this group were treated as usual in the clinic without additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 6-minutes walking distance
measured via GPS with the trackPAD app
Measured: baseline, 3 months follow-up
Secondary outcomes (3)
change in physical activity, measured in patients' self-report on how many days a week on average they engage in a physical activity that causes them to sweat or get out of breath, and how many minutes on average they spend doing it.
to compare the two groups groups in terms of physical endurance, the self-reported physical activity was recorded
Measured: baseline, 3 months follow-up
peripheral arterial disease-related quality of life
measured with the Peripheral artery disease Quality of Life Questionnaire (PADQOL) questionnaire, a validated PAD-specific questionnaire. Minimum score is 38 and maximum is 228, with higher values indicating a better outcome.
Measured: baseline, 3 months follow-up
Usability of the TrackPAD app
measured with the User version of the Mobile Application Rating Scale (uMars) questionnaire. The uMARS includes 3 factors, namely app quality, app subjective quality and perceived impact. Minimum score of the app quality scale is 4 and the maximum is 20. The App Subjective Quality scale has a minimum of 4 and a maximum of 20, and the Perceived Impact scale has a minimum of 6 and a maximum of 30. Higher values indicate a better outcome.
Measured: baseline, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start6 Dec 2018
- Primary completion28 Mar 2019
- Study completion30 Apr 2019
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.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Lortz, University Hospital, Essen
- Investigators
- Julia Lortz, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947228
- Sponsor's protocol ID
- 18-8355-BO
- Acronym
- TrackPAD
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paldan K, Simanovski J, Ullrich G, Steinmetz M, Rammos C, Janosi RA, Moebus S, Rassaf T, Lortz J. Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2019 Jun 26;8(6):e13651. doi: 10.2196/13651.
PubMed 31244477Paldan K, Steinmetz M, Simanovski J, Rammos C, Ullrich G, Janosi RA, Moebus S, Rassaf T, Lortz J. Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 16;9(8):e24214. doi: 10.2196/24214.
PubMed 34398800
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Randomized Controlled Pilot Trial.
- ClinicalTrials.gov ID
- NCT04947228
- Acronym / sponsor ID
- TrackPAD / 18-8355-BO
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 1 Jul 2021 (actual)
- 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.
The individual restrictions of daily life for patients with PAD are more important than statistical facts for mortality and morbidity. Intermittent claudication causes a progressive reduction of the pain-free walking distance (PWD) as an expression of a worsening PAD. This decrease in physical capability results in a decline of mental health and relevantly reduces the patients' quality of life (QoL).
Supervised exercise therapy (SET) is a cornerstone in the conservative management of intermittent claudication and extends the PWD. Even though SET is easy to practice and highly cost effective, the adherence to perform SET on a regular base is rather low. The underuse of exercise can be partly explained by the lack of institutional resources, but also by both patients' and physicians' lack of interest in exercise.
Mobile health (mHealth) technologies increase the incentives and provide digital support for patients with PAD on several treatment levels. They might lead to a higher adherence to exercise training and offer new scopes in patient-centered healthcare, but so far studies show opposite results. Because app stores are flooded with health and fitness apps, specific support tools are highly desired by patients with PAD and PAD-specific solutions are missing so far. Based on this background, the investigators developed a smartphone app named TrackPAD to provide PAD-specific support for SET.
The TrackPAD pilot study was designed as a 2-armed randomized controlled trial and included patients with diagnosed and symptomatic PAD. Patients were randomized by the Center for Clinical Studies in Essen using the TENALEA software into 2 groups. The control group included participants with standard care and no further mobile intervention. The intervention group included participants with standard care and additional mHealth-based self-tracking of their physical activity using trackPAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: trackPADin addition to the usual therapy, the patients were given access to the trackPAD app |
| control group | No intervention | –patients in this group were treated as usual in the clinic without additional interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of lower extremity PAD based on (and/or):
- PAD Fontaine Stage IIa/b
- Smartphone with possibility to use TrackPAD: Android ≥ 5.0 or IOS ≥ 11.0
- Written informed consent prior to any study procedures, including a specified follow-up evaluation
- Best-medical treatment in the last 2 months in accordance with standard guidelines
Key exclusion criteria (11 listed)
- Wheelchair bound, use of walking aid or walking impairment due to another cause than PAD
- Below or above knee amputation
- Acute or critical limb ischemia
- PAD Fontaine Stage I or III / IV
- No German knowledge
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 |
|---|---|---|
| trackPADTrackPAD is a smartphone app to provide PAD-specific support for SET | Device | intervention group |
Primary outcome
change in 6-minutes walking distance
Time frame: baseline, 3 months follow-up
measured via GPS with the trackPAD app
3 secondary outcomes
change in physical activity, measured in patients' self-report on how many days a week on average they engage in a physical activity that causes them to sweat or get out of breath, and how many minutes on average they spend doing it.
Time frame: baseline, 3 months follow-up
peripheral arterial disease-related quality of life
Time frame: baseline, 3 months follow-up
Usability of the TrackPAD app
Time frame: baseline, 3 months follow-up
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 1 Jul 2021.
- Background: PubMed 31244477Paldan K, Simanovski J, Ullrich G, Steinmetz M, Rammos C, Janosi RA, Moebus S, Rassaf T, Lortz J. Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2019 Jun 26;8(6):e13651. doi: 10.2196/13651.
- Derived from this study: PubMed 34398800Paldan K, Steinmetz M, Simanovski J, Rammos C, Ullrich G, Janosi RA, Moebus S, Rassaf T, Lortz J. Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 16;9(8):e24214. doi: 10.2196/24214.
- 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.
Julia Lortz principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trackPAD in people with Peripheral Arterial Disease, run by University Hospital, Essen at 1 site in Germany.
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 8 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 1 Jul 2021. 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 Germany. 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 6-minutes walking distance (time frame: baseline, 3 months follow-up). 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 NCT04947228, 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 1 Jul 2021.