ARTPERfit Clinical Trial.

NCT04578990 | Unknown

• 1 other identifier: PI20/00129
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Peripheral Arterial Disease; Arteriosclerosis

Keywords

Peripheral Arterial Disease; Physical Activity; Intermittent Claudication; Cardiovascular Disease; Ankle Brachial Index; Treadmill Test; Resistance Training; Functional Decline; Quality of Life

Outcome Measures

Primary Outcomes (10)

• 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

  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

Secondary Outcomes (4)

• Maintenance of objective in the long term

  12 months from the start of the study

• Keep exercising in the long term

  12 months from the start of the study

• Severity of peripheral arterial disease

  3 and 6 months from the start of the study

• Ankle-Brachial Index in the long term

  12 months from the start of the study

Study Arms (4)

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.

Other: Walking intervention

Strength intervention group

EXPERIMENTAL

The training program consists of performing a training program with resistance exercises for 36-72 weeks.

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.

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.

Interventions

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.

Walking intervention group

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.

Strength intervention group

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.

Concurrent intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a peripheral arterial disease with symptoms of intermittent claudication
• Age\> 40 years
• Signing of the informed consent to participate in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Unitat de Suport a la Recerca (Metropolitana Nord)

Mataró, Barcelona, 08303, Spain

Location

Related Publications (30)

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• 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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• Ankle 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.

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• Mostaza JM, Puras E, Blasco M, Lahoz C, Samaniego ML. Utilization of evidence-based cardiovascular therapies and achievement of therapeutic goals in patients with peripheral artery disease. Rev Esp Cardiol (Engl Ed). 2012 Aug;65(8):713-8. doi: 10.1016/j.recesp.2012.02.020. Epub 2012 May 31. English, Spanish.

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• 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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• Marrett 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.

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• Regensteiner 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.

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• McDermott 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.

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• McDermott 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.

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• F.S.Lozano Sánchez, J.R March García E Carrasco Carrasco. Profile of patients with intermittent claudication in Spain. The VITAL Study. Angiologia. 2013;65:131-140

  BACKGROUND

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  PMID: 35477870 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Arteriosclerosis; Motor Activity; Intermittent Claudication; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Teresa Alzamora Sas, MD and PhD

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Teresa Alzamora Sas, MD and PhD

CONTACT

0034649560266; maiteal2007@gmail.com

Gemma Seda Gombau, PhD

CONTACT

0034662234558; gemma.seda.ics@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Analysis masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: March 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2023
• Last Updated: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)