Aortic Aneurysm, AbdominalNCT01234610
Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease
A study testing Supervised exercise training in people with Aortic Aneurysm, Abdominal and Aneurysm, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Aneurysm, Aortic Disease
- What is being tested?
- Supervised exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Sheffield Hallam University
Sheffield, South Yorkshire, S102BP
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S57AU
About this study
Official title: Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Abdominal, Aneurysm, Aortic Disease, Vascular Disease, Cardiovascular Disease
- Being tested
- Supervised exercise training
- Keywords
- Exercise, Aortic aneurysm, Feasibility, Vascular disease
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm, Aortic Diseases, Vascular Diseases, Cardiovascular Diseases, Motor Activity, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise Receives: Behavioral: Supervised exercise training |
| Control | No intervention | No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
We will monitor how feasible it is to recruit, test and train patients with small AAAs
Measured: 12 weeks
Secondary outcomes (5)
Cardiopulmonary fitness
Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test
Measured: 12 weeks
Quality of life
Health-related quality of life assessed using the MOS SF-36 v2 questionaire
Measured: 12 weeks
Aneurysm size
Aneurysm size as measured using B-mode ultrasound
Measured: 12 weeks
Blood biomarker of disease progression
Fasting blood samples will be taken to assess changes in hs-CRP
Measured: 12 weeks
Blood biomarker of disease progression
Fasting blood samples will be taken to assess changes in MMP-9
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Sponsor
- Investigators
- Shah Nawaz, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation TrustGarry A Tew, PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234610
- Sponsor's protocol ID
- STH15455
- Status last verified
- Dec 2017
- First submitted
- 3 Nov 2010
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study
- ClinicalTrials.gov ID
- NCT01234610
- Acronym / sponsor ID
- STH15455
- Conditions
- Aortic Aneurysm, Abdominal, Aneurysm, Aortic Disease, Vascular Disease, Cardiovascular Disease
- Keywords
- Exercise, Aortic aneurysm, Feasibility, Vascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Supervised exercise trainingExercise |
| Control | No intervention | –No exercise |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise trainingPatients 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. | Behavioural | Exercise |
Primary outcome
Feasibility
Time frame: 12 weeks
We will monitor how feasible it is to recruit, test and train patients with small AAAs
5 secondary outcomes
Cardiopulmonary fitness
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Aneurysm size
Time frame: 12 weeks
Blood biomarker of disease progression
Time frame: 12 weeks
Blood biomarker of disease progression
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shah Nawaz, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
Garry A Tew, PhD principal investigator
Sheffield Hallam University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise training in people with Aortic Aneurysm, Abdominal and Aneurysm, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.