An interventional study of Multimodal intervention in Peripheral Arterial Disease, Asymptomatic Diseases and Ankle Brachial Index (0.9 or Less), sponsored by Värmland County Council, Sweden. Completed at 2 sites in Sweden. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Värmland County Council, Sweden · Not applicable, Interventional, and Other
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 16 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Värmland County Council, Sweden is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study has only one arm and one intervention as described under "interventions"
Other: Multimodal intervention
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.
Prevalence
Prevalence of asymptomatic peripheral disease in the screened population
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
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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Plan to share: 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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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Värmland County Council, Sweden