High-intensity interval exercise training prior to abdominal aortic aneurysm repair

High-intensity Interval exercise Training prior to Abdominal Aortic Aneurysm repair: a feasibility study (HIT AAA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09433624

Enrollment

Registered

2013-06-28

Start date

2013-08-01

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes

Interventions

The intervention being assessed during this feasibility project is high intensity interval exercise training (HIT). Participants allocated to this group will exercise 3 times per week, on a stationary

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing open or endovascular repair of a 5.5-7.0cm infrarenal abdominal aortic aneurysm 2. Age >=18 years (male and female)

Exclusion criteria

Exclusion criteria: 1. Refusal or inability to provide informed consent 2. Conservative management of Abdominal Aortic Aneurysm (AAA) 3. Suprarenal or thoracic aneurysms 4. Emergency AAA repair 5. Infrarenal AAA >7 cm 6. Contra-indication to undertaking Cardiopulmonary exercise test (CPET) or exercise training 7. Body mass index (BMI) 40 kg/m2 8. Participants identified as being 'high risk' clinically or consequent to CPET. This would include potential participants identified with conditions likely to be overtly exacerbated by exercise training e.g. unstable angina

Design outcomes

Primary

Measure	Time frame
The principal outcome objective of this study is to explore potential primary outcomes for a subsequent definitive randomised controlled trial (RCT). The physiological rationale suggests a causal pathway between adaptations consequent to exercise training and reduced mortality and morbidity. Potential primary outcomes for a definitive trial therefore include 30-day mortality, morbidity [Post-Operative Morbidity Survey (POMS) score], Quality of life (SF-36 and EQ5D), hospital length of stay, costs and cost-effectiveness.	—

Measure

Time frame

The principal outcome objective of this study is to explore potential primary outcomes for a subsequent definitive randomised controlled trial (RCT). The physiological rationale suggests a causal pathway between adaptations consequent to exercise training and reduced mortality and morbidity. Potential primary outcomes for a definitive trial therefore include 30-day mortality, morbidity [Post-Operative Morbidity Survey (POMS) score], Quality of life (SF-36 and EQ5D), hospital length of stay, costs and cost-effectiveness.

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Secondary

Measure	Time frame
1. Examine the suitability of the exercise training for a subsequent definitive RCT High-intensity interval training shows much promise as a time efficient, enjoyable, and effective intervention for improving fitness. However, it has not been employed with AAA patients awaiting repair. This will specifically involve assessing compliance, safety and enjoyment of the exercise intervention. 2. Examine the willingness of patients to be randomised and explore potential patient preferences. In RCTs patients might have strong treatment preferences resulting in a refusal to be randomised, affecting the generalisability of results. Or, they might agree to be randomised but suffer from ?resentful demoralisation? if they end up in the non-preferred arm of the trial leading to poor compliance. This issue requires examination in a feasibility study, as the preference effects for exercise vs. control in this patient population are unknown. Theoretically, patients might have a preference for the exercise arm due to a belief in the benefits. Notwithstanding the patient information provided, others might be fearful of engaging in high-intensity exercise prior to surgery and therefore might exhibit a preference for the control arm. These issues could affect the success of a definitive trial.	—

Measure

Time frame

1. Examine the suitability of the exercise training for a subsequent definitive RCT High-intensity interval training shows much promise as a time efficient, enjoyable, and effective intervention for improving fitness. However, it has not been employed with AAA patients awaiting repair. This will specifically involve assessing compliance, safety and enjoyment of the exercise intervention. 2. Examine the willingness of patients to be randomised and explore potential patient preferences. In RCTs patients might have strong treatment preferences resulting in a refusal to be randomised, affecting the generalisability of results. Or, they might agree to be randomised but suffer from ?resentful demoralisation? if they end up in the non-preferred arm of the trial leading to poor compliance. This issue requires examination in a feasibility study, as the preference effects for exercise vs. control in this patient population are unknown. Theoretically, patients might have a preference for the exercise arm due to a belief in the benefits. Notwithstanding the patient information provided, others might be fearful of engaging in high-intensity exercise prior to surgery and therefore might exhibit a preference for the control arm. These issues could affect the success of a definitive trial.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026