Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of Exercise on Patients With Claudication Undergoing Surgery

4. november 2013 opdateret af: Daniel Carradice, University of Hull

A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants

Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg?

Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more.

One treatment for claudication is exercising until the pain comes on; which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown.

This project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens.

Methods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Hull, Det Forenede Kongerige, HU3 2JZ
        • Rekruttering
        • Hull Royal Infirmary
        • Kontakt:
        • Ledende efterforsker:
          • Romesh Sarvanandan, MBBS MRCS

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

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Community dwelling older adults aged 45 and over
  • Diagnosis of intermittent claudication - ABPI < 0.9 with symptoms in keeping with intermittent claudication
  • Undergoing surgery for claudication
  • Ability to walk without assistance
  • Healthy control patients who are undergoing varicose vein surgery

Exclusion Criteria:

  • Participants who are unable to provide informed consent
  • Severe of acute cardiovascular, musculoskeletal or pulmonary illness
  • Critical limb ischaemia
  • Active treatment for cancer
  • Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)
  • Failure to complete a CPET

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supervised Exercise Program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
Tidsramme: 6 weeks
Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measure the changes in muscle fibre type with exercise training or standard care
Tidsramme: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Histological analysis to measure the percentage of different types of muscle fibres, and how these are affected by 6 weeks of exercise compared to standard treatment.
Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of endothelial function after a period or exercise therapy or standard care
Tidsramme: Baseline, 6 weeks, 3 months, 6 months, and 12 months
To identify if 6 weeks of exercise improves the endothelial function.
Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of inflammatory markers with exercise treatment or standard care
Tidsramme: Baseline, 6 weeks, 3 months, 6 months, and 12 months
To identify whether 6 weeks of exercise therapy improves inflammatory markers
Baseline, 6 weeks, 3 months, 6 months, and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Romesh Sarvanandan, MBBS MRCS, Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Forventet)

1. juli 2016

Datoer for studieregistrering

Først indsendt

24. september 2013

Først indsendt, der opfyldte QC-kriterier

4. november 2013

Først opslået (Skøn)

11. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2013

Sidst verificeret

1. november 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Perifer arteriel sygdom

Kliniske forsøg med Supervised Exercise program

Abonner