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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Peripheral arterial disease is part of the diseases derived from arteriosclerosis are the leading cause of mortality in developed countries. There is evidence of the benefits of physical exercise programs supervised in patients with cardiovascular risk. Despite being a treatment with proven efficacy and relatively inexpensive, it continues being little used for the management of patients with intermittent claudication caused by peripheral arterial disease.
The objective of this study is to develop an evidence-based intervention strategy on the effectiveness of supervised physical exercise in intermittent claudication to determine its impact compared to standard counselling in these patients.
Peripheral arterial disease is part of the diseases derived from arteriosclerosis, such as myocardial infarction or stroke. These entities are the leading cause of mortality in developed countries. The peripheral arterial disease is a narrowing of the diameter of the arteries in the legs due to plaque formation of atheroma. When the obstruction is significant enough, there is a decrease in blood flow to the musculature of the lower limbs and consequently, depending on the severity of the narrowing, we can find from asymptomatic patients to patients with atrophic lesions, going through different degrees of pain when walking or at rest.
It is estimated that in 2010 more than 200 million people had peripheral arterial disease worldwide, with symptoms that range from mild to severe. The forecast is heading towards an increase in prevalence due to the increase in the life span of the world population and cardiovascular risk factors.
There is evidence in countries with high cardiovascular risk regarding the benefit obtained in physical exercise programs supervised in patients with pain when walking, both in increasing the distance walked and in prolonging at the time of onset of pain. Despite being a treatment with proven efficacy and relatively inexpensive, it continues being little used for the management of patients with intermittent claudication caused by arteriopathy in Spain.
This project aims to assess the effectiveness of various supervised physical exercise programs in patients with Symptomatic Peripheral Artery Disease (Intermittent Claudication) versus single advice to exercise without supervision. After a first initial assessment visit, four groups will be formed at random. A control group who will be given standard advice to perform physical exercise and three experimental intervention groups. They will be assessed at 3 and 6 months after performing sessions of supervised exercise lasting one hour 3 times a week and 12 months after the initial visit, (after 6 months of end supervised exercise sessions). The impact in terms of changes in quality of life will also be evaluated.
In the longer term, and depending on the results obtained, it is intended to implement a similar intervention, at the level of primary care, or as close as possible to the place of residence of this type of patient to facilitate the performance of the exercise, improve the symptoms and quality of life of these patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking intervention group | Experimental | It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly. |
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| Strength intervention group | Experimental | The training program consists of performing a training program with resistance exercises for 36-72 weeks. |
|
| Concurrent intervention group | Experimental | The training program consists of alternating strength and resistance stimuli in the same session for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied for 35 minutes and to complete the 60 minutes, the same guidelines will be followed as in the walking exercise, applying resistance stimuli. |
|
| Control group | No Intervention | It will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking intervention | Other | It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly. Depending on the data obtained in Visit 1, the speed will be determined for each patient and the degree of the initial slope that is comfortable when walking until it induces symptoms of moderate intermittent claudication. The progression of the intensity of the speed and incline of the slope will be increased progressively and individually for each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain-free walking distance | Pain-free walking distance using Treadmill based walking | 3 months from the start of the study |
| Pain-free walking distance | Pain-free walking distance using Treadmill based walking | 6 months from the start of the study |
| Pain-free walking distance | Pain-free walking distance using the 6-minute walk test distance | 3 months from the start of the study |
| Pain-free walking distance | Pain-free walking distance using the 6-minute walk test distance | 6 months from the start of the study |
| General functional state | General functional state using the Barthel questionnaire. | 3 months from the start of the study |
| General functional state | General functional state using the Barthel questionnaire. | 6 months from the start of the study |
| Perceived quality of life level | Perceived quality of life level | 3 months from the start of the study |
| Perceived quality of life level | Perceived quality of life level |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of objective in the long term | Determine the maintenance of objectives 1, 2 and 3, 6 months after completing the intervention | 12 months from the start of the study |
| Keep exercising in the long term |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Teresa Alzamora Sas, MD and PhD | Contact | 0034649560266 | maiteal2007@gmail.com | |
| Gemma Seda Gombau, PhD | Contact | 0034662234558 | gemma.seda.ics@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Teresa Alzamora Sas, MD and PhD | Institut Català de la Salut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unitat de Suport a la Recerca (Metropolitana Nord) | Mataró | Barcelona | 08303 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23915883 | Background | Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1. | |
| 22727799 |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D001161 | Arteriosclerosis |
| D009043 | Motor Activity |
| D007383 | Intermittent Claudication |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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Randomized longitudinal controlled trial, parallel, blinded to the analysis, with a sample of participants studied between 3 and 6 months after starting a physical exercise program. Participants will be randomly assigned to four groups. Intervention walking group: The intervention will consist of carrying out the walking training progression. The strength group will carry out a resistance training program. The concurrent training intervention group will carry out an exercise program that will alternate strength and endurance training in the same session. Both experimental groups will hold 36-72 sessions, with a frequency of 3 sessions per week and 60 minutes per session. The control group will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level warning.
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Analysis masking
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|
| Strength intervention | Other | The training program consists of performing a training program with resistance exercises for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied. The same guidelines will be followed as in the walking exercise, but in this case, applying force stimuli. If symptoms of moderate intermittent claudication occur (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain disappears at the level of the lower limb. This sequence will be repeated until the strength training session is completed. The progression of force stimuli will be increased weekly depending on the subjective perception of the patient's effort and according to the guidelines set by our group of investigation. |
|
| Concurrent intervention | Other | The training program consists of alternating strength and resistance stimuli in the same session for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied for 35 minutes and to complete the 60 minutes, the same guidelines will be followed as in the walking exercise, applying resistance stimuli. If claudication symptoms occur moderate intermittent (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain in the lower extremity disappears. This sequence will be repeated until the 20 minutes established to end the session are completed concurrent training. The progression of the strength and resistance stimuli will be increased weekly depending on the perception subjective effort of the patient and according to the guidelines established by our research group. |
|
| 6 months from the start of the study |
| Ankle-Brachial Index (ABI) | To know if the proposed training programs improve the ankle-brachial index. | 3 months from the start of the study |
| Ankle-Brachial Index (ABI) | To know if the proposed training programs improve the ankle-brachial index. | 6 months from the start of the study |
To know the proportion of subjects who continue to exercise 6 months after completing the study
| 12 months from the start of the study |
| Severity of peripheral arterial disease | Determine objectives 1, 2 and 3 concerning the severity of peripheral arterial disease (according to baseline ABI) at 3 and 6 months of an exercise program supervised physicist. | 3 and 6 months from the start of the study |
| Ankle-Brachial Index in the long term | Analyze the changes in the ankle-brachial index at 12 months from the start of the study. | 12 months from the start of the study |
| Felix-Redondo FJ, Fernandez-Berges D, Grau M, Baena-Diez JM, Mostaza JM, Vila J. Prevalence and clinical characteristics of peripheral arterial disease in the study population Hermex. Rev Esp Cardiol (Engl Ed). 2012 Aug;65(8):726-33. doi: 10.1016/j.recesp.2012.03.008. Epub 2012 Jun 22. English, Spanish. |
| 19515589 | Background | Ramos R, Quesada M, Solanas P, Subirana I, Sala J, Vila J, Masia R, Cerezo C, Elosua R, Grau M, Cordon F, Juvinya D, Fito M, Isabel Covas M, Clara A, Angel Munoz M, Marrugat J; REGICOR Investigators. Prevalence of symptomatic and asymptomatic peripheral arterial disease and the value of the ankle-brachial index to stratify cardiovascular risk. Eur J Vasc Endovasc Surg. 2009 Sep;38(3):305-11. doi: 10.1016/j.ejvs.2009.04.013. Epub 2009 Jun 10. |
| 20529387 | Background | Alzamora MT, Fores R, Baena-Diez JM, Pera G, Toran P, Sorribes M, Vicheto M, Reina MD, Sancho A, Albaladejo C, Llussa J; PERART/ARTPER study group. The peripheral arterial disease study (PERART/ARTPER): prevalence and risk factors in the general population. BMC Public Health. 2010 Jan 27;10:38. doi: 10.1186/1471-2458-10-38. |
| 19190551 | Background | Blanes JI, Cairols MA, Marrugat J; ESTIME. Prevalence of peripheral artery disease and its associated risk factors in Spain: The ESTIME Study. Int Angiol. 2009 Feb;28(1):20-5. |
| 25432124 | Background | Sampson UK, Fowkes FG, McDermott MM, Criqui MH, Aboyans V, Norman PE, Forouzanfar MH, Naghavi M, Song Y, Harrell FE Jr, Denenberg JO, Mensah GA, Ezzati M, Murray C. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014 Mar;9(1):145-158.e21. doi: 10.1016/j.gheart.2013.12.008. |
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| Background | Mostaza JM, Puras E, Blasco M, et al. Utilización de tratamientos cardiovasculares preventivos y consecución de objetivos terapéuticos en pacientes con enfermedad arterial periférica. Rev Esp Cardiol. 2012;65:713 -8. |
| 27894602 | Background | Fores R, Alzamora MT, Pera G, Valverde M, Angla M, Baena-Diez JM, Mundet-Tuduri X. Evolution and degree of control of cardiovascular risk factors after 5 years of follow-up and their relationship with the incidence of peripheral arterial disease: ARTPER cohort. Med Clin (Barc). 2017 Feb 9;148(3):107-113. doi: 10.1016/j.medcli.2016.09.043. Epub 2016 Nov 25. English, Spanish. |
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| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |