Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery

NCT03985202 | Unknown

• 1 other identifier: IRAS194690
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

exercise programme

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Health related Quality of Life (HRQoL) scores

  1 week and 3 months post end of exercise programme

• Change in Psychological Health Status

  1 week and 3 months post end of exercise programme

• Change in weight

  1 week and 3 months post end of exercise programme

• Change in cardiopulmonary exercise test

  1 week and 3 months post end of exercise programme

• Change in smoking status

  1 week and 3 months post end of exercise programme

Study Arms (1)

Structured Exercise Programme

EXPERIMENTAL

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.

Other: Structured exercise programme

Interventions

Structured exercise programme OTHER

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.

Also known as: Qualitiative interviews and questionnaires

Structured Exercise Programme

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Torbay and South Devon NHS Foundation Trust: lead

Study Sites (1)

Torbay Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Mike Swart

CONTACT

01803 654310; michael.swart@nhs.net

Fiona Roberts

CONTACT

01803 656635; fiona.roberts@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomised interventional observational study. Pilot study. 60 patients to be recruited from the Torbay AAA screening programme and AAA surveillance group over a two-year period. Cardiopulmonary exercise test and survival prediction when AAA reaches 4.5 cm. (Current clinical practice). 9 week structured exercise programme. 3 sessions per week. (Intervention). Repeat cardiopulmonary exercise test and survival prediction after structured exercise programme. Advice given for on going exercise and maintenance of fitness. (Intervention). Repeat cardiopulmonary exercise test and survival prediction after 3 months after structured exercise programme. (Intervention). Pateitns are asked to complete the following questionnaires:- EQ-5D-5L and Hospital Anxiety and Depression Scale (HADS) before, after the last exercise session and 3 months after the exercise programme. Change in medical or drug history. Change in weight or smoking.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 13, 2019
• Study Start: July 4, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)