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Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sheffield Hallam University
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01234610
First received: November 3, 2010
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
Aneurysm
Aortic Disease
Vascular Disease
Cardiovascular Disease
Behavioral: Supervised exercise training
Behavioral: Usual care control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We will monitor how feasible it is to recruit, test and train patients with small AAAs


Secondary Outcome Measures:
  • Cardiopulmonary fitness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test

  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Health-related quality of life assessed using the MOS SF-36 v2 questionaire

  • Aneurysm size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Aneurysm size as measured using B-mode ultrasound

  • Blood biomarker of disease progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fasting blood samples will be taken to assess changes in hs-CRP

  • Blood biomarker of disease progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fasting blood samples will be taken to assess changes in MMP-9


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Behavioral: Supervised exercise training
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.
No Intervention: Control Behavioral: Usual care control
Usual care, no active intervention

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT01234610

Contacts
Contact: Garry A Tew, PhD +44(0)1142252358 g.tew@shu.ac.uk

Locations
United Kingdom
Sheffield Hallam University Recruiting
Sheffield, South Yorkshire, United Kingdom, S102BP
Contact: Garry A Tew, PhD    +44(0)1142252358    g.tew@shu.ac.uk   
Principal Investigator: Garry A Tew, PhD         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S57AU
Contact: Shah Nawaz, MD    +44(0)1142269224    shah.nawaz@sth.nhs.uk   
Principal Investigator: Shah Nawaz, MD         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Investigators
Principal Investigator: Shah Nawaz, MD Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Garry A Tew, PhD Sheffield Hallam University
  More Information

No publications provided

Responsible Party: Lance Burn, Research Coordinator, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01234610     History of Changes
Other Study ID Numbers: STH15455
Study First Received: November 3, 2010
Last Updated: November 4, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Exercise
Aortic aneurysm
Feasibility
Vascular disease

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014