NCT01234610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

November 3, 2010

Last Update Submit

December 18, 2017

Conditions

Aortic Aneurysm, AbdominalAneurysmAortic DiseaseVascular DiseaseCardiovascular Disease

Keywords

ExerciseAortic aneurysmFeasibilityVascular disease

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    We will monitor how feasible it is to recruit, test and train patients with small AAAs

    12 weeks

Secondary Outcomes (5)

  • Cardiopulmonary fitness

    12 weeks

  • Quality of life

    12 weeks

  • Aneurysm size

    12 weeks

  • Blood biomarker of disease progression

    12 weeks

  • Blood biomarker of disease progression

    12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise

Behavioral: Supervised exercise training

Control

NO INTERVENTION

No exercise

Interventions

Supervised exercise trainingBEHAVIORAL

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.

Exercise

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheffield Hallam University

Sheffield, South Yorkshire, S102BP, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S57AU, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAneurysmAortic DiseasesVascular DiseasesCardiovascular DiseasesMotor ActivityAortic Aneurysm

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shah Nawaz, MD

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Garry A Tew, PhD

    Sheffield Hallam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

GB(2)