Trial record 9 of 34 for:    Open Studies | "Intermittent Claudication"

Effect of Exercise on Patients With Claudication Undergoing Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Hull
Sponsor:
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT01980602
First received: September 24, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Intermittent Claudication
Peripheral Arterial Disease
Procedure: Supervised Exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness


Secondary Outcome Measures:
  • Measure the changes in muscle fibre type with exercise training or standard care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    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.

  • Measurement of endothelial function after a period or exercise therapy or standard care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    To identify if 6 weeks of exercise improves the endothelial function.

  • Measurement of inflammatory markers with exercise treatment or standard care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
    To identify whether 6 weeks of exercise therapy improves inflammatory markers


Estimated Enrollment: 70
Study Start Date: March 2011
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised Exercise Program Procedure: Supervised Exercise program

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980602

Contacts
Contact: Romesh Sarvanandan, MBBS MRCS 01482674643 romesh1985@doctors.org.uk

Locations
United Kingdom
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Romesh Sarvanandan, MBBS MRCS    01482674643    romesh1985@doctors.org.uk   
Principal Investigator: Romesh Sarvanandan, MBBS MRCS         
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Romesh Sarvanandan, MBBS MRCS Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
  More Information

No publications provided

Responsible Party: Daniel Carradice, Academic Clinical Lecturer, University of Hull
ClinicalTrials.gov Identifier: NCT01980602     History of Changes
Other Study ID Numbers: 11/YH/0210
Study First Received: September 24, 2013
Last Updated: November 4, 2013
Health Authority: UK Research Ethics Committee: Bradford, England

Keywords provided by University of Hull:
Intermittent claudication
endothelial function
cardiopulmonary testing
inflammation
muscle architecture

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on August 28, 2014