Peripheral Arterial DiseaseARTPERfitNCT04578990
ARTPERfit Clinical Trial.
A study testing Walking intervention, Strength intervention and Concurrent intervention in people with Peripheral Arterial Disease and Arteriosclerosis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Arteriosclerosis
- What is being tested?
- Walking intervention, Strength intervention and Concurrent intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 30 Aug 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a peripheral arterial disease with symptoms of intermittent claudication
- Age> 40 years
- Signing of the informed consent to participate in the study
Who cannot join
- Critical ischemia and/or acute lower extremity ischemia
- Previous bilateral lower extremity revascularization.
- Lower limb amputation
- Major surgery in the previous 3 months or scheduled in the next year
- Cardiovascular, pulmonary, neurological and osteoarticular diseases that prevent the performance of the intervention.
- The appearance of intermittent claudication 30-45 minutes after the start of a claudication.
- Inability to go to the centre due to lack of time or limiting illness
- To participate, subjects must obtain medical consent to participate in a physical exercise intervention.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unitat de Suport a la Recerca (Metropolitana Nord)
Mataró, Barcelona, 08303
Maria Teresa Alzamora Sas, MD and PhD, 0034649560266, maiteal2007@gmail.com
Gemma s Seda Gombau, PhD, 0034662234558, gemma.seda.ics@gmail.com
About this study
Official title: Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
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.
Read the detailed description
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
- Conditions
- Peripheral Arterial Disease, Arteriosclerosis
- Being tested
- Walking intervention, Strength intervention, Concurrent intervention
- Keywords
- Peripheral Arterial Disease, Physical Activity, Intermittent Claudication, Cardiovascular Disease, Ankle Brachial Index, Treadmill Test, Resistance Training, Functional Decline, Quality of Life
- Medical subject headings
- Peripheral Arterial Disease, Arteriosclerosis, Motor Activity, Intermittent Claudication, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking interventionOther
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.
Strength interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Walking intervention |
| Strength intervention group | Experimental | The training program consists of performing a training program with resistance exercises for 36-72 weeks. Receives: Other: Strength intervention |
| 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. Receives: Other: Concurrent intervention |
| Control group | No intervention | It will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free walking distance
Pain-free walking distance using Treadmill based walking
Measured: 3 months from the start of the study
Pain-free walking distance
Pain-free walking distance using Treadmill based walking
Measured: 6 months from the start of the study
Pain-free walking distance
Pain-free walking distance using the 6-minute walk test distance
Measured: 3 months from the start of the study
Pain-free walking distance
Pain-free walking distance using the 6-minute walk test distance
Measured: 6 months from the start of the study
General functional state
General functional state using the Barthel questionnaire.
Measured: 3 months from the start of the study
General functional state
General functional state using the Barthel questionnaire.
Measured: 6 months from the start of the study
Perceived quality of life level
Perceived quality of life level
Measured: 3 months from the start of the study
Perceived quality of life level
Perceived quality of life level
Measured: 6 months from the start of the study
Ankle-Brachial Index (ABI)
To know if the proposed training programs improve the ankle-brachial index.
Measured: 3 months from the start of the study
Ankle-Brachial Index (ABI)
To know if the proposed training programs improve the ankle-brachial index.
Measured: 6 months from the start of the study
Secondary outcomes (4)
Maintenance of objective in the long term
Determine the maintenance of objectives 1, 2 and 3, 6 months after completing the intervention
Measured: 12 months from the start of the study
Keep exercising in the long term
To know the proportion of subjects who continue to exercise 6 months after completing the study
Measured: 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.
Measured: 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.
Measured: 12 months from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Mar 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Maria Teresa Alzamora Sas, MD and PhD, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578990
- Sponsor's protocol ID
- PI20/00129
- Acronym
- ARTPERfit
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23915883Felix-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.
PubMed 22727799Ramos 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.
PubMed 19515589Alzamora 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.
PubMed 20529387Blanes 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.
PubMed 19190551Sampson 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.
PubMed 25432124Ankle Brachial Index Collaboration; Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, deBacker G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d'Agostino RB, Murabito JM, Norman PE, Jamrozik K, Curb JD, Masaki KH, Rodriguez BL, Dekker JM, Bouter LM, Heine RJ, Nijpels G, Stehouwer CD, Ferrucci L, McDermott MM, Stoffers HE, Hooi JD, Knottnerus JA, Ogren M, Hedblad B, Witteman JC, Breteler MM, Hunink MG, Hofman A, Criqui MH, Langer RD, Fronek A, Hiatt WR, Hamman R, Resnick HE, Guralnik J, McDermott MM. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA. 2008 Jul 9;300(2):197-208. doi: 10.1001/jama.300.2.197.
PubMed 18612117Alzamora MT, Fores R, Pera G, Toran P, Heras A, Sorribes M, Baena-Diez JM, Urrea M, Alegre J, Viozquez M, Vela C. Ankle-brachial index and the incidence of cardiovascular events in the Mediterranean low cardiovascular risk population ARTPER cohort. BMC Cardiovasc Disord. 2013 Dec 17;13:119. doi: 10.1186/1471-2261-13-119.
PubMed 24341531Criqui MH, McClelland RL, McDermott MM, Allison MA, Blumenthal RS, Aboyans V, Ix JH, Burke GL, Liu K, Shea S. The ankle-brachial index and incident cardiovascular events in the MESA (Multi-Ethnic Study of Atherosclerosis). J Am Coll Cardiol. 2010 Oct 26;56(18):1506-12. doi: 10.1016/j.jacc.2010.04.060.
PubMed 20951328Mostaza 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.
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.
PubMed 27894602Marrett E, DiBonaventura Md, Zhang Q. Burden of peripheral arterial disease in Europe and the United States: a patient survey. Health Qual Life Outcomes. 2013 Oct 22;11:175. doi: 10.1186/1477-7525-11-175.
PubMed 24148832Regensteiner JG, Hiatt WR, Coll JR, Criqui MH, Treat-Jacobson D, McDermott MM, Hirsch AT. The impact of peripheral arterial disease on health-related quality of life in the Peripheral Arterial Disease Awareness, Risk, and Treatment: New Resources for Survival (PARTNERS) Program. Vasc Med. 2008 Feb;13(1):15-24. doi: 10.1177/1358863X07084911.
PubMed 18372434McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599.
PubMed 11585483McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, Pearce WH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, Clark E. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. 2004 Jul 28;292(4):453-61. doi: 10.1001/jama.292.4.453.
PubMed 15280343
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04578990
- Acronym / sponsor ID
- ARTPERfit / PI20/00129
- Conditions
- Peripheral Arterial Disease, Arteriosclerosis
- Keywords
- Peripheral Arterial Disease, Physical Activity, Intermittent Claudication, Cardiovascular Disease, Ankle Brachial Index, Treadmill Test, Resistance Training, Functional Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 8 Oct 2020 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Walking intervention group | Experimental | Other: Walking interventionIt will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly. |
| Strength intervention group | Experimental | Other: Strength interventionThe training program consists of performing a training program with resistance exercises for 36-72 weeks. |
| Concurrent intervention group | Experimental | Other: Concurrent interventionThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a peripheral arterial disease with symptoms of intermittent claudication
- Age> 40 years
- Signing of the informed consent to participate in the study
Key exclusion criteria (8 listed)
- Critical ischemia and/or acute lower extremity ischemia
- Previous bilateral lower extremity revascularization.
- Lower limb amputation
- Major surgery in the previous 3 months or scheduled in the next year
- Cardiovascular, pulmonary, neurological and osteoarticular diseases that prevent the performance of the intervention.
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 |
|---|---|---|
| Walking interventionIt 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. | Other | Walking intervention group |
| Strength interventionThe 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. | Other | Strength intervention group |
| Concurrent interventionThe 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. | Other | Concurrent intervention group |
Primary outcome
Pain-free walking distance
Time frame: 3 months from the start of the study
Pain-free walking distance using Treadmill based walking
Pain-free walking distance
Time frame: 6 months from the start of the study
Pain-free walking distance using Treadmill based walking
Pain-free walking distance
Time frame: 3 months from the start of the study
Pain-free walking distance using the 6-minute walk test distance
Pain-free walking distance
Time frame: 6 months from the start of the study
Pain-free walking distance using the 6-minute walk test distance
General functional state
Time frame: 3 months from the start of the study
General functional state using the Barthel questionnaire.
General functional state
Time frame: 6 months from the start of the study
General functional state using the Barthel questionnaire.
Perceived quality of life level
Time frame: 3 months from the start of the study
Perceived quality of life level
Perceived quality of life level
Time frame: 6 months from the start of the study
Perceived quality of life level
Ankle-Brachial Index (ABI)
Time frame: 3 months from the start of the study
To know if the proposed training programs improve the ankle-brachial index.
Ankle-Brachial Index (ABI)
Time frame: 6 months from the start of the study
To know if the proposed training programs improve the ankle-brachial index.
4 secondary outcomes
Maintenance of objective in the long term
Time frame: 12 months from the start of the study
Keep exercising in the long term
Time frame: 12 months from the start of the study
Severity of peripheral arterial disease
Time frame: 3 and 6 months from the start of the study
Ankle-Brachial Index in the long term
Time frame: 12 months from the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 23915883Fowkes 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.
- Background: PubMed 22727799Felix-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.
- Background: PubMed 19515589Ramos 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.
- Background: PubMed 20529387Alzamora 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.
- Background: PubMed 19190551Blanes 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.
- Background: PubMed 25432124Sampson 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.
- Background: PubMed 18612117Ankle Brachial Index Collaboration; Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, deBacker G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d'Agostino RB, Murabito JM, Norman PE, Jamrozik K, Curb JD, Masaki KH, Rodriguez BL, Dekker JM, Bouter LM, Heine RJ, Nijpels G, Stehouwer CD, Ferrucci L, McDermott MM, Stoffers HE, Hooi JD, Knottnerus JA, Ogren M, Hedblad B, Witteman JC, Breteler MM, Hunink MG, Hofman A, Criqui MH, Langer RD, Fronek A, Hiatt WR, Hamman R, Resnick HE, Guralnik J, McDermott MM. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA. 2008 Jul 9;300(2):197-208. doi: 10.1001/jama.300.2.197.
- Background: PubMed 24341531Alzamora MT, Fores R, Pera G, Toran P, Heras A, Sorribes M, Baena-Diez JM, Urrea M, Alegre J, Viozquez M, Vela C. Ankle-brachial index and the incidence of cardiovascular events in the Mediterranean low cardiovascular risk population ARTPER cohort. BMC Cardiovasc Disord. 2013 Dec 17;13:119. doi: 10.1186/1471-2261-13-119.
- Background: PubMed 20951328Criqui MH, McClelland RL, McDermott MM, Allison MA, Blumenthal RS, Aboyans V, Ix JH, Burke GL, Liu K, Shea S. The ankle-brachial index and incident cardiovascular events in the MESA (Multi-Ethnic Study of Atherosclerosis). J Am Coll Cardiol. 2010 Oct 26;56(18):1506-12. doi: 10.1016/j.jacc.2010.04.060.
- BackgroundMostaza 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.
- Background: PubMed 27894602Fores 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.
- Background: PubMed 24148832Marrett E, DiBonaventura Md, Zhang Q. Burden of peripheral arterial disease in Europe and the United States: a patient survey. Health Qual Life Outcomes. 2013 Oct 22;11:175. doi: 10.1186/1477-7525-11-175.
- Individual participant dataSharing planned: No
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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.
Maria Teresa Alzamora Sas, MD and PhD principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking intervention, Strength intervention and Concurrent intervention in people with Peripheral Arterial Disease and Arteriosclerosis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 8 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Teresa Alzamora Sas, MD and PhD (0034649560266, maiteal2007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-free walking distance (time frame: 3 months from the start of the study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578990, which also lists 30 linked publications.
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 14 Oct 2020.