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Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication

25. marts 2020 opdateret af: Rita Lombardini, University Of Perugia

Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication

Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.

The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.

The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Italien
    • PG
      • Perugia, PG, Italien, 06132
        • Ospedale "Santa Maria della Misericordia" di Perugia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 80 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • history of stable intermittent claudication (PAD, stage II Fontaine)
  • resting ankle-brachial index (ABI) <0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning

Exclusion Criteria:

  • lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
  • inability to obtain the ABI value or to perform a walking test
  • exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
  • end-stage liver or renal failure
  • acute or chronic inflammatory conditions
  • history of recent (<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
  • treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Healthy control
Voluntary subjects without peripheral arterial disease
Sham-komparator: IC patients, no exercise
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity
Adfærdsmæssigt: sham exercise
general recommendation to perform regular aerobic physical activity
Aktiv komparator: IC patients, exercise
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise
Adfærdsmæssigt: combined aerobic and resistance physical activity
Five training sessions weekly for 12 weeks are scheduled. Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training. The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved. Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery. Duration of repetitions increases every 3 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endothelial Microparticles (EMPs)
Tidsramme: week 0 - week 12
hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
week 0 - week 12
Endothelial Progenitor Cells (EPCs)
Tidsramme: week 0 - week 12
hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
week 0 - week 12
Maximum Walking Time
Tidsramme: week 0 - week 12
functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
week 0 - week 12
Pain-free Walking Time
Tidsramme: week 0 - week 12
maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
week 0 - week 12
Flow-mediated Dilation
Tidsramme: week 0 - week 12
ultrasonographic evaluation of endothelial function
week 0 - week 12

Samarbejdspartnere og efterforskere

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Sponsor

University Of Perugia

Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

1. marts 2020

Primær færdiggørelse (Forventet)

31. december 2020

Studieafslutning (Forventet)

1. januar 2021

Datoer for studieregistrering

Først indsendt

5. marts 2020

Først indsendt, der opfyldte QC-kriterier

7. marts 2020

Først opslået (Faktiske)

10. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APE-IC1

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Perifer arteriel sygdom

Kliniske forsøg med sham exercise

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