Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery

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Brief Title

Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery

Official Title

Can a Structured Exercise Programme Improve the Predicted Survival for Planned Abdominal Aortic Aneurysm Surgery Patients?

Brief Summary

      There is a relationship between aerobic fitness and survival both with and without surgery.
      Some patients can improve their aerobic fitness with a structured exercise programme but
      currently it is not know how much this could change predicted survival for patients with an
      abdominal aortic aneurysm, or how long this change can be maintained. Survival can be
      predicted after planned abdominal aortic aneurysm (AAA) surgery using physical fitness
      measured with a cardiopulmonary exercise test. The researchers have validated this in a
      published peer reviewed multicentre study. In this study the patient's fitness will be
      measured before and after a structured exercise programme and assess if there is any change
      in their predicted survival. The primary objective of the study is to measure the change in
      predicted survival for abdominal aortic aneurysm surgery after a structured exercise
      programme. In addition the patients are asked to complete the following questionnaires:-
      EQ-5D-5L, Hospital Anxiety and Depression Scale (HADS) before and after the exercise
      programme.
    

Detailed Description

      The UK has a national AAA screening programme. At the age of 65 men are offered a one off
      ultrasound test to look for a AAA. If their abdominal aorta is > 5.5 cm they are referred to
      a Vascular Surgeon. If the patients abdominal aorta is between 3 cm and 5.4 cm they are
      offered further ultrasound scans to monitor the size of their aorta. This is a surveillance
      programme. In addition men who have an AAA between 3 cm and 5.4 cm that is detected by an
      ultrasound scan, CT or MRI performed as part of an investigation for another clinical problem
      are added to the surveillance programme.

      In Torbay and South Devon men in the AAA surveillance programme are referred for a
      Cardiopulmonary Exercise Test when the AAA reaches 4.5 cm as part of standard clinical
      practice. This takes place in the Pre assessment Clinic in Torbay Hospital and is performed
      by a Consultant Anaesthetist. If the patient is able to safely perform the Cardiopulmonary
      Exercise Test they will be identified as potential participants by the Consultant
      Anaesthetist.
    


Study Type

Interventional


Primary Outcome

Change in predicted mortality: 30- day postoperative mortality (%) or median survival (years).

Secondary Outcome

 Change in Health related Quality of Life (HRQoL) scores

Condition

Abdominal Aortic Aneurysm

Intervention

Structured exercise programme

Study Arms / Comparison Groups

 Structured Exercise Programme
Description:  An initial 45 min exercise counselling incorporating behaviour modification techniques.
Participants will be offered three sessions per week of aerobic interval exercise on a cycle ergometer over nine weeks. Exercise programmes will be tailored to each patient, taking previous level of activity, mobility and any barriers to exercise into consideration.
Following this:
Participants will be encouraged to comply with current physical activity recommendations: 150 min of moderate intensity aerobic exercise per week (brisk walking / cycling). They will also be sign posted to local exercise facilities.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

July 4, 2019

Completion Date

June 30, 2021

Primary Completion Date

June 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Male participants ≥ 18

          2. Under surveillance as part of the AAA screening or surveillance programme with an AAA
             that is between 4.5 cm and 5.4 cm

          3. Able and willing to provide informed consent

          4. Understand verbal and written instructions in English

          5. Able to safely perform a cardiopulmonary exercise test (this will confirm they can use
             a cycle ergometer)

          6. Patients who are already participating (or have participated) in other trials may be
             eligible, but the relevant trial teams must agree this in advance.-

        Exclusion Criteria:

          1. Contra-indications to exercise (lower limb amputation without prosthesis, bone, joint
             or muscle problem which may be exacerbated by exercise, chronic lung disease causing
             desaturation with exercise or shortness of breath at rest, severe psychiatric health
             problems)

          2. Cardiovascular contra-indications (unstable angina, acute left ventricular failure,
             uncontrolled cardiac arrhythmias, uncontrolled hypertension, cardiac event in the
             previous 6 weeks, cerebral vascular accident in the previous 6 weeks)

          3. Participation in other treatment trials, where this has not been agreed in advance
             with both trial teams

          4. Symptomatic AAA

          5. Urgency of surgery for AAA precludes undertaking exercise programme. -
      

Gender

All

Ages

18 Years - 110 Years

Accepts Healthy Volunteers

No

Contacts

, 01803 654310, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03985202

Organization ID

IRAS194690


Responsible Party

Sponsor

Study Sponsor

Torbay and South Devon NHS Foundation Trust


Study Sponsor

, , 


Verification Date

July 2019