Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03985202
• Other study ID #: IRAS194690
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2022
• Source: Torbay and South Devon NHS Foundation Trust
• Contact: Mike Swart
• Phone: 01803 654310
• Email: michael.swart[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Other:
• Structured exercise programme
9 week structured exercise programme. 3 sessions per week. (Intervention).The patient will be invited to the hospital for a 45-minute exercise counselling session, incorporating behaviour modification techniques. These behaviour modification techniques will be reinforced during the supervised exercise sessions. Participants will be offered 3 sessions of supervised aerobic interval exercise sessions per week on a cycle ergometer for 9 weeks.Exercise programmes will be tailored to each patient, taking previous level of activity, mobility and any barriers to exercise into consideration.

Locations

Country	Name	City	State
United Kingdom	Torbay Hospital	Torquay	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Torbay and South Devon NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in predicted mortality: 30- day postoperative mortality (%) or median survival (years).	We can predict survival after planned abdominal aortic aneurysm (AAA) surgery using physical fitness measured with a cardiopulmonary exercise test, age and comorbidities. We have validated this in a published peer reviewed multicentre study. We will measure patient's fitness 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.	3 months post end of exercise programme
Secondary	Change in Health related Quality of Life (HRQoL) scores	Metric: Completion of EuroQol EQ5D-5L questionnaires before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme	1 week and 3 months post end of exercise programme
Secondary	Change in Psychological Health Status	Metric: Completion of Hospital Anxiety and Depression (HAD) questionnaire before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme	1 week and 3 months post end of exercise programme
Secondary	Change in weight	Metric: Change in weight before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme	1 week and 3 months post end of exercise programme
Secondary	Change in cardiopulmonary exercise test	Metric: Change in cardiopulmonary fitness variables (VO2, anearobic threshold, VE/VCO2,oxygen pulse), as measured using an incremental Cardiopulmonary exercise test (CPET) before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme	1 week and 3 months post end of exercise programme
Secondary	Change in smoking status	Metric: Change in smoking habits (stopped, reduced) before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme	1 week and 3 months post end of exercise programme