- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01980602
Effect of Exercise on Patients With Claudication Undergoing Surgery
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Hull, Storbritannia, HU3 2JZ
- Rekruttering
- Hull Royal Infirmary
-
Ta kontakt med:
- Romesh Sarvanandan, MBBS MRCS
- Telefonnummer: 01482674643
- E-post: romesh1985@doctors.org.uk
-
Hovedetterforsker:
- Romesh Sarvanandan, MBBS MRCS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Supervised Exercise Program
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Romesh Sarvanandan, MBBS MRCS, Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11/YH/0210
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Perifer arteriell sykdom
-
Mayo ClinicPåmelding etter invitasjonAnatomi av GSV for Rescue Peripheral IV AccessForente stater
-
Universitaire Ziekenhuizen KU LeuvenUniversity of Pittsburgh; Sheba Medical Center; Mount Sinai Hospital, Canada og andre samarbeidspartnereUkjentTwin Reversal Arterial Perfusion SyndromeSpania, Tyskland, Israel, Belgia, Nederland, Canada, Forente stater, Østerrike, Frankrike, Italia, Storbritannia
-
Lawson Health Research InstituteFullførtArteriosclerosis of arterial coronary artery bypass graftCanada
-
Deutsches Herzzentrum MuenchenFullførtArteriosclerosis of arterial coronary artery bypass graftTyskland
-
University of MiamiRekrutteringTvilling til tvillingtransfusjonssyndrom | Tvilling; Kompliserer graviditet | Twin Reversal Arterial Perfusion Syndrome | Monokorionisk diamniotisk placenta | Monokorial monoamniotisk placentaForente stater
-
Boston Children's HospitalHar ikke rekruttert ennåGraviditetsrelatert | Mors; Fremgangsmåte | Fosterets tilstander | Tvilling Monochorionic Monoamniotic Placenta | Tvilling til tvillingtransfusjonssyndrom | Twin Reversal Arterial Perfusion Syndrome | Vasa Previa | In utero-prosedyre som påvirker foster eller nyfødt | Chorion; Unormal | KorioangiomForente stater
Kliniske studier på Supervised Exercise program
-
Ahram Canadian UniversityRekrutteringCervikal smerte | LivmorhalsenEgypt
-
Hull University Teaching Hospitals NHS TrustUniversity of HullFullførtIntermitterende Claudication | Femoropoliteal sykdomStorbritannia
-
Dana-Farber Cancer InstituteProstate Cancer FoundationRekrutteringPROSTATAKREFT | Metastatisk prostatakreft | Metastatisk prostatakarsinomForente stater
-
University of MinnesotaHar ikke rekruttert ennå
-
Dartmouth-Hitchcock Medical CenterAvsluttetLungekreftForente stater
-
University of FloridaRekruttering
-
University of Illinois at ChicagoNational Center for Advancing Translational Sciences (NCATS)Har ikke rekruttert ennå
-
Dr. John BartlettSligo General Hospital; Institute of Technology, SligoUkjent
-
Marmara UniversityFullførtKontorarbeidere | Arbeidsrelaterte muskel- og skjelettlidelserTyrkia