- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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-
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Hull, Regno Unito, HU3 2JZ
- Reclutamento
- Hull Royal Infirmary
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Contatto:
- Romesh Sarvanandan, MBBS MRCS
- Numero di telefono: 01482674643
- Email: romesh1985@doctors.org.uk
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Investigatore principale:
- Romesh Sarvanandan, MBBS MRCS
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Supervised Exercise Program
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
Lasso di tempo: 6 weeks
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Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
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6 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Measure the changes in muscle fibre type with exercise training or standard care
Lasso di tempo: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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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.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
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Measurement of endothelial function after a period or exercise therapy or standard care
Lasso di tempo: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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To identify if 6 weeks of exercise improves the endothelial function.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
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Measurement of inflammatory markers with exercise treatment or standard care
Lasso di tempo: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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To identify whether 6 weeks of exercise therapy improves inflammatory markers
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Baseline, 6 weeks, 3 months, 6 months, and 12 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Romesh Sarvanandan, MBBS MRCS, Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11/YH/0210
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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