Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-15 @ 3:35 AM
Study NCT ID:
NCT01980602
Status:
UNKNOWN
Last Update Posted:
2013-11-11
First Post:
2013-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise on Patients With Claudication Undergoing Surgery
Sponsor:
University of Hull
Organization:
Study Overview
Official Title:
A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
Status:
UNKNOWN
Status Verified Date:
2013-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 onÍž 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.
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 onÍž 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: