Peripheral Arterial DiseasePilotPreAPADNCT07897396
The Effect of a Multimodal Preventive Intervention in Patients With Asymptomatic Peripheral Artery Disease
A study testing Multimodal intervention in people with Peripheral Arterial Disease and Asymptomatic Diseases, run by Värmland County Council, Sweden at 2 sites in Sweden.
Trial summary
This pilot study, the PilotPreAPAD study, will be carried out to check whether the key parts of the planned Prevention in asymptomatic Arterial Disease (PreAPAD) study will work in practice. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Asymptomatic Diseases, Ankle Brachial Index (0.9 or Less)
- What is being tested?
- Multimodal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Nov 2024to 13 Jun 2025
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type II diabetes
- A history of smoking combined with hypertension
- Chronic obstructive pulmonary disease (COPD) together with hypertension
Who cannot join
- Manifest atherosclerotic cardiovascular disease
- Dementia
- Type I diabetes
- Insufficient proficiency in Swedish
- Severe illness or disability preventing participation in a physical exercise program
- Short expected survival
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Vårdcentralen Gripen
Karlstad, Värmland County, 65224
Vårdcentralen Skoghall
Skoghall, Värmland County, 66330
About this study
Official title: A Pilot Study for a Randomized Controlled Trial on the Effect of a Multimodal Preventive Intervention in Patients With Asymptomatic Peripheral Arterial Disease (PilotPreAPAD)
This pilot study, the PilotPreAPAD study, will be carried out to check whether the key parts of the planned Prevention in asymptomatic Arterial Disease (PreAPAD) study will work in practice. In phase one, it will test the screening process for asymptomatic arterial disease and the prevalence of the disease in the screened population to help estimate the sample size needed before starting the larger randomized multi centre PreAPAD study. In phase two, the pilot will test the study protocol, the data collection tools and how acceptable the intervention will be to participants.
Peripheral artery disease is a disease where the arteries in the legs are narrowed by atherosclerosis causing pain in the affected limb during exercise and resting pain, ulcers and tissue loss in the more severe stage. Many people, however, are in the stage where they have no leg symptoms, even though they have narrowed arteries, the asymptomatic stage. Despite having no symptoms, they have almost double the risk of developing angina, heart attack, stroke, or dying prematurely-similar to those with more advanced disease.
Read more
The disease can be easily detected by measuring the blood pressure in the ankle and comparing it to the blood pressure in the arm. This is called the Ankle-Brachial Index (ABI). Measuring ABI makes it possible to identify people at higher risk of future heart and vascular events-risks that can potentially be prevented.
The PreAPAD study that is being planned aims to examine how preventive strategies affect heart- and other vascular events, quality of life, and disease progression in men and women with asymptomatic peripheral artery disease. Patients with diabetes, high blood pressure, COPD, or a history of smoking will be screened with ABI measurements to detect asymptomatic disease. The multimodal intervention that will be tested includes a health discussion with a nurse, participation in a health course, individualized exercise advice from a physiotherapist, exercise training, and medication to manage risk factors for cardiovascular disease if needed.
- Being tested
- Multimodal intervention
- Keywords
- prevention, multimodal intervention, peripheral arterial disease, screening, asymptomatic disease, ankle brachial index
- Medical subject headings
- Peripheral Arterial Disease, Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal interventionOther
The multimodal intervention consisted of
- individual meeting with a study nurse for identification of cardiovascular risk factors in life-style habits, body mass index, level of low-density lipoprotein, blood pressure and glycated hemoglobin (HbA1c) and construction of a health plan
- Pharmacological treatment of cholesterol, diabetes and hypertension if necessary
- Individual meeting with a physiotherapist for advice on physical exercise
- Six weeks of twice a week center-based, physiotherapist-supervised exercise training and one additional exercise session once a week individually
- followed self-directed exercise training three times a week for six weeks.
- Group sessions on healthy lifestyle and behavioural changes
- Access to a digital platform that supplied information on peripheral arterial disease and beneficial lifestyle modifications.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Ankle/Brachial index < 0.90 or > 1.4 | Experimental | This study has only one arm and one intervention as described under "interventions" Receives: Other: Multimodal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Prevalence of asymptomatic peripheral disease in the screened population
Measured: At the end of phase one after six weeks of screening enrolled patients between week 45 in 2024 and week 2 in 2025
Quality from the Patient´s Perspective (QPP)
To assess the quality and relevance of the intervention domains a questionnaire was developed consistent with the framework "Quality from the Patient´s Perspective (QPP)". Respondents assessed each item on perceived quality and importance, using a four-point Likert scale ranging from strong agreement or highest importance (1) to no agreement or minimal importance (4).
Measured: Within two weeks after completion of the intervention
Six-Minute walking test (6MWT)
Physical capacity was assessed using the Six-Minute Walk Test (6MWT), administered by a physiotherapist
Measured: At baseline, after six weeks of supervised exercize training and after six weeks of self-directed training
Modifiable cardiovascular risk factor: s-LDL
Level of serum low density lipoprotein in mmol/L
Measured: baseline
Modifiable cardiovascular risk factor: smoking habits
Self-reported measure on smoking habits by multiple choice questionnaire Possible answers: never smoker, stopped smoking for more than six months ago, stopped smoking for less than six months ago, smoking not on a daily basis, daily smoker
Measured: Baseline
Modifiable cardiovascular risk factor: BMI
Body mass index (BMI) was calculated by dividing the participants' weight in kilograms by the square of their height in meters.
Measured: Baseline
Modifiable cardiovascular risk factor: dietary habits
Dietary habits were evaluated using the dietary index score, which reflects adherence to national nutritional recommendations. The index ranges from 0-12, with scores of 0-4 indicating significantly unhealthy dietary habits, 5-8 indicates less healthy eating habits and 9-12 indicating healthy dietary patterns.
Measured: Baseline
Modifiable cardiovascular risk factor: Risky alcohol consumption
Self reported alcohol consumption where consumption of ≥10 standard drinks (≥120 grams of pure alcohol) per week, or binge drinking (≥4 units) at least once a month constitutes risky alcohol use.
Measured: Baseline
Modifiable cardiovascular risk factor: Blood pressure
Blood pressure in the arm measured in millimeters of mercury (mmHg), where a systolic pressure ≥ 140 was considered a risk factor
Measured: Baseline
Modifiable cardiovascular risk factor: sedentary behavior
Standardized question in questionnaire estimated hours sedentary time each day, excluding sleeping hours, with the alternatives: the whole day, 13-15 hours, 10-12 hours, 7-9 hours, 4-6 hours, 1-3 hours and no sedentary time.
Measured: Baseline
Modifiable cardiovascular risk factor: activity minutes
Physical activity habits were assessed using two standardized questions estimating time spent in exercise and everyday physical activity during a usual week. These questions generated a continuous outcome of total phsical activity : "Activity minutes". The "activity minutes" are calculated as minutes of exercise x 2 plus minutes of physical activity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start4 Nov 2024
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study designed to test core feasibility domains as the screening procedures for asymptomatic peripheral arterial disease, protocol , data tool validation, intervention acceptability, and sample size estimation prior to the planned randomized multi-centre PreAPAD study.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maaike Giezeman, Värmland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897396
- Sponsor's protocol ID
- 2024-03664-01
- Other IDs
- LIVFOU1010429 and LIVFOU 10053, 7D5571D901FB494993677FDB21D233
- Acronym
- PilotPreAPAD
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected in this pilot study will be made available to qualified researchers upon reasonable request. The shared data will include participant-level data underlying the main study outcomes and feasibility measures, as well as the corresponding data dictionary. No directly identifiable information will be shared. Data will become available after publication of the primary study results and will remain available for a period of up to five years. Requests for access must include a brief research proposal and a statistical analysis plan. Data access will be granted following review and approval by the study investigators and execution of a data sharing agreement. The data will be shared for the purpose of academic, non-commercial research related to feasibility methods, multimodal interventions, or prevention of asymptomatic peripheral arterial disease. Data will be provided in an anonymized format via a secure data transfer method.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Randomized Controlled Trial on the Effect of a Multimodal Preventive Intervention in Patients With Asymptomatic Peripheral Arterial Disease (PilotPreAPAD)
- ClinicalTrials.gov ID
- NCT07897396
- Acronym / sponsor ID
- PilotPreAPAD / 2024-03664-01
- Keywords
- prevention, multimodal intervention, peripheral arterial disease, screening, asymptomatic disease, ankle brachial index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 27 Oct 2026 (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.
This pilot study, the PilotPreAPAD study, will be carried out to check whether the key parts of the planned Prevention in asymptomatic Arterial Disease (PreAPAD) study will work in practice. In phase one, it will test the screening process for asymptomatic arterial disease and the prevalence of the disease in the screened population to help estimate the sample size needed before starting the larger randomized multi centre PreAPAD study. In phase two, the pilot will test the study protocol, the data collection tools and how acceptable the intervention will be to participants.
Peripheral artery disease is a disease where the arteries in the legs are narrowed by atherosclerosis causing pain in the affected limb during exercise and resting pain, ulcers and tissue loss in the more severe stage. Many people, however, are in the stage where they have no leg symptoms, even though they have narrowed arteries, the asymptomatic stage. Despite having no symptoms, they have almost double the risk of developing angina, heart attack, stroke, or dying prematurely-similar to those with more advanced disease.
The disease can be easily detected by measuring the blood pressure in the ankle and comparing it to the blood pressure in the arm. This is called the Ankle-Brachial Index (ABI). Measuring ABI makes it possible to identify people at higher risk of future heart and vascular events-risks that can potentially be prevented.
The PreAPAD study that is being planned aims to examine how preventive strategies affect heart- and other vascular events, quality of life, and disease progression in men and women with asymptomatic peripheral artery disease. Patients with diabetes, high blood pressure, COPD, or a history of smoking will be screened with ABI measurements to detect asymptomatic disease. The multimodal intervention that will be tested includes a health discussion with a nurse, participation in a health course, individualized exercise advice from a physiotherapist, exercise training, and medication to manage risk factors for cardiovascular disease if needed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study designed to test core feasibility domains as the screening procedures for asymptomatic peripheral arterial disease, protocol , data tool validation, intervention acceptability, and sample size estimation prior to the planned randomized multi-centre PreAPAD study.
| Arm | Type | Receives |
|---|---|---|
| Individuals with Ankle/Brachial index < 0.90 or > 1.4 | Experimental | Other: Multimodal interventionThis study has only one arm and one intervention as described under "interventions" |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with type II diabetes
- A history of smoking combined with hypertension
- Chronic obstructive pulmonary disease (COPD) together with hypertension
Key exclusion criteria (6 listed)
- Manifest atherosclerotic cardiovascular disease
- Dementia
- Type I diabetes
- Insufficient proficiency in Swedish
- Severe illness or disability preventing participation in a physical exercise program
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 |
|---|---|---|
| Multimodal interventionThe multimodal intervention consisted of * individual meeting with a study nurse for identification of cardiovascular risk factors in life-style habits, body mass index, level of low-density lipoprotein, blood pressure and glycated hemoglobin (HbA1c) and construction of a health plan * Pharmacological treatment of cholesterol, diabetes and hypertension if necessary * Individual meeting with a physiotherapist for advice on physical exercise * Six weeks of twice a week center-based, physiotherapist-supervised exercise training and one additional exercise session once a week individually * followed self-directed exercise training three times a week for six weeks. * Group sessions on healthy lifestyle and behavioural changes * Access to a digital platform that supplied information on peripheral arterial disease and beneficial lifestyle modifications. | Other | Individuals with Ankle/Brachial index < 0.90 or > 1.4 |
Primary outcome
Prevalence
Time frame: At the end of phase one after six weeks of screening enrolled patients between week 45 in 2024 and week 2 in 2025
Prevalence of asymptomatic peripheral disease in the screened population
Quality from the Patient´s Perspective (QPP)
Time frame: Within two weeks after completion of the intervention
To assess the quality and relevance of the intervention domains a questionnaire was developed consistent with the framework "Quality from the Patient´s Perspective (QPP)". Respondents assessed each item on perceived quality and importance, using a four-point Likert scale ranging from strong agreement or highest importance (1) to no agreement or minimal importance (4).
Six-Minute walking test (6MWT)
Time frame: At baseline, after six weeks of supervised exercize training and after six weeks of self-directed training
Physical capacity was assessed using the Six-Minute Walk Test (6MWT), administered by a physiotherapist
Modifiable cardiovascular risk factor: s-LDL
Time frame: baseline
Level of serum low density lipoprotein in mmol/L
Modifiable cardiovascular risk factor: smoking habits
Time frame: Baseline
Self-reported measure on smoking habits by multiple choice questionnaire Possible answers: never smoker, stopped smoking for more than six months ago, stopped smoking for less than six months ago, smoking not on a daily basis, daily smoker
Modifiable cardiovascular risk factor: BMI
Time frame: Baseline
Body mass index (BMI) was calculated by dividing the participants' weight in kilograms by the square of their height in meters.
Modifiable cardiovascular risk factor: dietary habits
Time frame: Baseline
Dietary habits were evaluated using the dietary index score, which reflects adherence to national nutritional recommendations. The index ranges from 0-12, with scores of 0-4 indicating significantly unhealthy dietary habits, 5-8 indicates less healthy eating habits and 9-12 indicating healthy dietary patterns.
Modifiable cardiovascular risk factor: Risky alcohol consumption
Time frame: Baseline
Self reported alcohol consumption where consumption of ≥10 standard drinks (≥120 grams of pure alcohol) per week, or binge drinking (≥4 units) at least once a month constitutes risky alcohol use.
Modifiable cardiovascular risk factor: Blood pressure
Time frame: Baseline
Blood pressure in the arm measured in millimeters of mercury (mmHg), where a systolic pressure ≥ 140 was considered a risk factor
Modifiable cardiovascular risk factor: sedentary behavior
Time frame: Baseline
Standardized question in questionnaire estimated hours sedentary time each day, excluding sleeping hours, with the alternatives: the whole day, 13-15 hours, 10-12 hours, 7-9 hours, 4-6 hours, 1-3 hours and no sedentary time.
Modifiable cardiovascular risk factor: activity minutes
Time frame: Baseline
Physical activity habits were assessed using two standardized questions estimating time spent in exercise and everyday physical activity during a usual week. These questions generated a continuous outcome of total phsical activity : "Activity minutes". The "activity minutes" are calculated as minutes of exercise x 2 plus minutes of physical activity.
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected in this pilot study will be made available to qualified researchers upon reasonable request. The shared data will include participant-level data underlying the main study outcomes and feasibility measures, as well as the corresponding data dictionary. No directly identifiable information will be shared. Data will become available after publication of the primary study results and will remain available for a period of up to five years. Requests for access must include a brief research proposal and a statistical analysis plan. Data access will be granted following review and approval by the study investigators and execution of a data sharing agreement. The data will be shared for the purpose of academic, non-commercial research related to feasibility methods, multimodal interventions, or prevention of asymptomatic peripheral arterial disease. Data will be provided in an anonymized format via a secure data transfer method.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention in people with Peripheral Arterial Disease and Asymptomatic Diseases, run by Värmland County Council, Sweden at 2 sites in Sweden.
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 3 inclusion and 6 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 3 Nov 2026. 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 Sweden. 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?
Prevalence (time frame: At the end of phase one after six weeks of screening enrolled patients between week 45 in 2024 and week 2 in 2025). The study lists 11 primary outcomes in all. 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 3 Nov 2026.