- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03985202
Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery
Can a Structured Exercise Programme Improve the Predicted Survival for Planned Abdominal Aortic Aneurysm Surgery Patients?
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mike Swart
- Phone Number: 01803 654310
- Email: michael.swart@nhs.net
Study Contact Backup
- Name: Fiona Roberts
- Phone Number: 01803 656635
- Email: fiona.roberts@nhs.net
Study Locations
-
-
Devon
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Torquay, Devon, United Kingdom, TQ2 7AA
- Recruiting
- Torbay Hospital
-
Contact:
- Fiona Roberts
- Email: fiona.roberts@nhs.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male participants ≥ 18
- Under surveillance as part of the AAA screening or surveillance programme with an AAA that is between 4.5 cm and 5.4 cm
- Able and willing to provide informed consent
- Understand verbal and written instructions in English
- Able to safely perform a cardiopulmonary exercise test (this will confirm they can use a cycle ergometer)
- 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:
- 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)
- 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)
- Participation in other treatment trials, where this has not been agreed in advance with both trial teams
- Symptomatic AAA
- Urgency of surgery for AAA precludes undertaking exercise programme. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Structured Exercise Programme
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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in predicted mortality: 30- day postoperative mortality (%) or median survival (years).
Time Frame: 3 months post end of exercise programme
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health related Quality of Life (HRQoL) scores
Time Frame: 1 week and 3 months post end of exercise programme
|
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
|
Change in Psychological Health Status
Time Frame: 1 week and 3 months post end of exercise programme
|
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
|
Change in weight
Time Frame: 1 week and 3 months post end of exercise programme
|
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
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1 week and 3 months post end of exercise programme
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Change in cardiopulmonary exercise test
Time Frame: 1 week and 3 months post end of exercise programme
|
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
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1 week and 3 months post end of exercise programme
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Change in smoking status
Time Frame: 1 week and 3 months post end of exercise programme
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS194690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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