Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease
Primary Purpose
Aortic Aneurysm, Abdominal, Aneurysm, Aortic Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supervised exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Exercise, Aortic aneurysm, Feasibility, Vascular disease
Eligibility Criteria
Inclusion Criteria:
- Men or women identified as having a stable 30 to 49 mm asymptomatic, infra-renal AAA, measured using high-resolution B-mode ultrasonography
- Ability to undertake exercise testing and training
Exclusion Criteria:
- Patients with large (>50 mm)/symptomatic AAAs
- Patients with contraindications to exercise testing/training (e.g. severe hypertension, unstable metabolic/cardiopulmonary conditions, musculoskeletal injuries etc…)
- Patients who are unable to travel to the testing and training facility at Sheffield Hallam University
- Patients who are already participating in regular exercise
- Patients with a mental impairment that would render consent unethical or would make compliance difficult (e.g. dementia or Alzheimer's)
Sites / Locations
- Sheffield Hallam University
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
Exercise
No exercise
Outcomes
Primary Outcome Measures
Feasibility
We will monitor how feasible it is to recruit, test and train patients with small AAAs
Secondary Outcome Measures
Cardiopulmonary fitness
Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test
Quality of life
Health-related quality of life assessed using the MOS SF-36 v2 questionaire
Aneurysm size
Aneurysm size as measured using B-mode ultrasound
Blood biomarker of disease progression
Fasting blood samples will be taken to assess changes in hs-CRP
Blood biomarker of disease progression
Fasting blood samples will be taken to assess changes in MMP-9
Full Information
NCT ID
NCT01234610
First Posted
November 3, 2010
Last Updated
December 18, 2017
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
1. Study Identification
Unique Protocol Identification Number
NCT01234610
Brief Title
Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease
Official Title
Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. Large AAAs (>55 mm diameter) carry a high risk of rupture, a surgical emergency that often leads to death due to severe internal bleeding. It has been suggested that regular exercise training might limit the rate at which AAAs develop. However, little is known about the safety and effectiveness of exercise training in these patients. This pilot study will examine the feasibility of supervised aerobic exercise training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize that exercise training will be safe and useful for patients with small AAAs.
Detailed Description
Abdominal aortic aneurysm (AAA) disease is a potentially lethal health problem of older adults. New screening initiatives will identify many individuals with small (30 to 49 mm) AAAs for which there are currently no treatment options. Regular aerobic exercise might retard AAA disease progression, but the feasibility and acceptability of aerobic exercise in patients with AAA disease has yet to be established. This pilot study will examine the feasibility of supervised aerobic exercise and exercise advice-only in patients with small AAAs. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the supervised exercise programme will be offered three supervised cycle ergometry/treadmill-walking sessions for a period of 12 weeks. The feasibility of each intervention will be assessed in terms of recruitment and compliance, attrition, changes in cardiopulmonary fitness and objective measures of free-living physical activity. Changes in aneurysm size and blood markers associated with disease progression will also be monitored and the impact of the interventions on health-related quality of life assessed using a questionnaire. Outcomes will be assessed at baseline and 12 weeks. We will also conduct focus groups at the end of the trial to obtain qualitative feedback from patients. The results of this study will inform the design of a multi-centre randomised controlled trial with longer-term follow-up of clinical end-points.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Aneurysm, Aortic Disease, Vascular Disease, Cardiovascular Disease
Keywords
Exercise, Aortic aneurysm, Feasibility, Vascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise training
Intervention Description
Patients will be asked to attend three exercise sessions per week for 12 weeks. They will exercise in groups of up to four per session and they will be supervised by an experienced exercise physiologist. Each session will comprise 5 to 10 min warm-up period (involving very light aerobic exercise and a range of gentle movements), 30 min of light-to-moderate intensity aerobic exercise (cycle-ergometry and or treadmill-walking), and a 5 to 10 min cool-down period involving low-intensity aerobic exercise and gentle stretching. The intensity of the aerobic exercise will be individualised and will be progressed gradually (if appropriate) during the course of the study.
Primary Outcome Measure Information:
Title
Feasibility
Description
We will monitor how feasible it is to recruit, test and train patients with small AAAs
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cardiopulmonary fitness
Description
Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test
Time Frame
12 weeks
Title
Quality of life
Description
Health-related quality of life assessed using the MOS SF-36 v2 questionaire
Time Frame
12 weeks
Title
Aneurysm size
Description
Aneurysm size as measured using B-mode ultrasound
Time Frame
12 weeks
Title
Blood biomarker of disease progression
Description
Fasting blood samples will be taken to assess changes in hs-CRP
Time Frame
12 weeks
Title
Blood biomarker of disease progression
Description
Fasting blood samples will be taken to assess changes in MMP-9
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women identified as having a stable 30 to 49 mm asymptomatic, infra-renal AAA, measured using high-resolution B-mode ultrasonography
Ability to undertake exercise testing and training
Exclusion Criteria:
Patients with large (>50 mm)/symptomatic AAAs
Patients with contraindications to exercise testing/training (e.g. severe hypertension, unstable metabolic/cardiopulmonary conditions, musculoskeletal injuries etc…)
Patients who are unable to travel to the testing and training facility at Sheffield Hallam University
Patients who are already participating in regular exercise
Patients with a mental impairment that would render consent unethical or would make compliance difficult (e.g. dementia or Alzheimer's)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shah Nawaz, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Garry A Tew, PhD
Organizational Affiliation
Sheffield Hallam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Hallam University
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S102BP
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S57AU
Country
United Kingdom
12. IPD Sharing Statement
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Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease
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