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New treatment option for Peripheral Arterial Disease
Official title Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
ClinicalTrials.gov ID: NCT06410521
What this study is testing
- What it's testing
- Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Intermittent claudication (IC) is the most common symptom in this disease that appears with exertion and relieves with rest, causing fatigue, cramps, discomfort, or pain in the lower limbs due to limited blood flow to the affected muscles.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Diagnosed with clinically stable PAD;
- An ankle-brachial index (ABI) between 0.41-0.90 at rest in one or both lower limbs;
- Mild to moderate claudication, corresponding to Fontaine Stage IIa and IIb;
- A history of ambulatory leg pain;
- Ambulatory leg pain confirmed by treadmill test;
You likely can't join if
- Noncompressible, calcified, tibial arteries (resting ABI ≥ 1.4);
- Use of medication that could influence claudication (e.g. Cilostazol or Pentoxifylline) 3 months prior to investigation;
- Previous intervention (e.g. balloon angioplasty, stenting, bypass, exercise programme);
- Inability to walk on a treadmill at a speed of 3.2 km/h (2 mph);
- Participation in the past 3 months in a clinical trial or exercise program;
- Asymptomatic PAD determined from the medical history;
See the full eligibility criteria
- Diagnosed with clinically stable PAD;
- An ankle-brachial index (ABI) between 0.41-0.90 at rest in one or both lower limbs;
- Mild to moderate claudication, corresponding to Fontaine Stage IIa and IIb;
- A history of ambulatory leg pain;
- Ambulatory leg pain confirmed by treadmill test;
- Able to provide written consent.
- Noncompressible, calcified, tibial arteries (resting ABI ≥ 1.4);
- Use of medication that could influence claudication (e.g. Cilostazol or Pentoxifylline) 3 months prior to investigation;
- Previous intervention (e.g. balloon angioplasty, stenting, bypass, exercise programme);
- Inability to walk on a treadmill at a speed of 3.2 km/h (2 mph);
- Participation in the past 3 months in a clinical trial or exercise program;
- Asymptomatic PAD determined from the medical history;
- Exercise limited by factors other diseases or conditions than intermittent claudication;
- Angina pectoris, congestive heart failure, chronic obstructive pulmonary disease, severe arthritis, or limb amputation.
The study team makes the final eligibility decision.
Where it's taking place
- Vila Real, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vila Real, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.