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Effect of Exercise on Patients With Claudication Undergoing Surgery

Primary Purpose

Intermittent Claudication, Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supervised Exercise program
Sponsored by
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Intermittent claudication, endothelial function, cardiopulmonary testing, inflammation, muscle architecture

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hull Royal InfirmaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supervised Exercise Program

Arm Description

Outcomes

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
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
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
To identify if 6 weeks of exercise improves the endothelial function.
Measurement of inflammatory markers with exercise treatment or standard care
To identify whether 6 weeks of exercise therapy improves inflammatory markers

Full Information

First Posted
September 24, 2013
Last Updated
November 4, 2013
Sponsor
University of Hull
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1. Study Identification

Unique Protocol Identification Number
NCT01980602
Brief Title
Effect of Exercise on Patients With Claudication Undergoing Surgery
Official Title
A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hull

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Peripheral Arterial Disease
Keywords
Intermittent claudication, endothelial function, cardiopulmonary testing, inflammation, muscle architecture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise Program
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Supervised Exercise program
Primary Outcome Measure Information:
Title
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
Description
Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Measure the changes in muscle fibre type with exercise training or standard care
Description
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.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months
Title
Measurement of endothelial function after a period or exercise therapy or standard care
Description
To identify if 6 weeks of exercise improves the endothelial function.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months
Title
Measurement of inflammatory markers with exercise treatment or standard care
Description
To identify whether 6 weeks of exercise therapy improves inflammatory markers
Time Frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romesh Sarvanandan, MBBS MRCS
Phone
01482674643
Email
romesh1985@doctors.org.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romesh Sarvanandan, MBBS MRCS
Organizational Affiliation
Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romesh Sarvanandan, MBBS MRCS
Phone
01482674643
Email
romesh1985@doctors.org.uk
First Name & Middle Initial & Last Name & Degree
Romesh Sarvanandan, MBBS MRCS

12. IPD Sharing Statement

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Effect of Exercise on Patients With Claudication Undergoing Surgery

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