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Brief 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. 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.

Outcome Measures

Primary Outcomes (11)

Prevalence
Prevalence of asymptomatic peripheral disease in the screened population
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).
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

Interventions

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.

Individuals with Ankle/Brachial index < 0.90 or > 1.4

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

OTHER

Intervention Model

SINGLE GROUP

Model Details: 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.

Sponsor Type

OTHER GOV

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

MD PhD

The Effect of a Multimodal Preventive Intervention in Patients With Asymptomatic Peripheral Artery Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (11)

Study Arms (1)

Individuals with Ankle/Brachial index < 0.90 or > 1.4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (11)

Study Arms (1)

Individuals with Ankle/Brachial index < 0.90 or > 1.4

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations