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Trial registered on ANZCTR


Registration number
ACTRN12623000190606
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
23/02/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Saving Legs & Lives: Cardiovascular rehabilitation following leg vascular surgery.
Scientific title
Saving Legs & Lives: The efficacy of cardiovascular rehabilitation versus usual care on exercise capacity and quality of life in patients who have undergone lower limb revascularisation for peripheral arterial disease.
Secondary ID [1] 308907 0
‘Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral artery disease 328906 0
intermittent claudication 328907 0
Condition category
Condition code
Cardiovascular 325897 325897 0 0
Diseases of the vasculature and circulation including the lymphatic system
Physical Medicine / Rehabilitation 326019 326019 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6-week community-based cardiovascular rehabilitation program (intervention condition). Participants randomised to the cardiovascular rehabilitation program will be referred to the cardiovascular rehabilitation program of the Sunshine Coast Hospital and Health Service. The cardiovascular rehabilitation program will be delivered by the research personnel and the cardiovascular rehabilitation team (e.g., nurses, clinical exercise physiologist). During the community-based cardiovascular rehabilitation program, participants will attend two 60-minute supervised exercise sessions per week for a total of 6 weeks. During the 6-week program participants will also be provided with exercise guidelines and advice to complete at least 3 home-based walking sessions per week. In addition to the supervised and home-based sessions, participants will attend one education seminar in total during the 6-week program. Following the completion of the cardiovascular rehabilitation program, a member of the research team will provide participants with individualised exercise and physical activity advice (e.g., suggest continuation of exercise program at local gym) with the goal to meet the recommended 150-300 minutes of moderate intensity physical activity levels per week. The exercise and physical activity advice will be provided via a one-to-one discussion lasting 10-15 minutes at the end of the cardiovascular rehabilitation program (e.g., at the post-program assessment point).

Supervised exercise sessions
During each supervised exercise session participants will be monitored by the cardiovascular rehabilitation team and research personnel. The research personnel will be responsible for the prescription and progression of the exercises. The exercises prescribed to participants will be in accordance with the current exercise guidelines for patients with peripheral artery disease and will include lower limb aerobic exercises (e.g., treadmill walking), lower limb resistance exercises (e.g., calf raises) and upper limb exercises (e.g., arm cycling). The exercise sessions will be mainly driven by limb discomfort. Participants will be encouraged to exercise at a moderate to near-maximal claudication pain threshold (3/4 based on claudication pain scale) or if asymptomatic, exercise at a moderate exercise intensity (3/10 based on Borg-RPE scale). The duration of the treadmill walking will progressively increase from 10 minutes at the beginning of the program (i.e., week 1) to 30 minutes at the end of the program (i.e., week 6).

Home-based walking sessions
In addition to the supervised exercise sessions, participants will be provided with home-based exercise guidelines and advice to complete at least 3 home-based walking sessions per week. Participants will be encouraged to walk at a moderate to near-maximal claudication pain threshold (3/4 based on claudication pain scale) or if asymptomatic, walk at a moderate exercise intensity (3/10 based on Borg-RPE scale). Similar to the supervised exercise sessions, duration of home-based walking sessions will progressively increase from 10 minutes at the beginning of the program (i.e., week 1) to 30 minutes at the end of the program (i.e., week 6). Participants will be provided with a diary to record their home-based walking sessions.

Education seminar
Participants will also attend one education seminar (5.5 hours with breaks for morning tea and lunch) during the 6-week program which will be delivered by health specialists including, nurses, exercise physiologists, dietitians, and psychologists. The education seminar will cover topics such as diet, medications, exercise, physical activities, and lifestyle modifications for secondary prevention of cardiovascular diseases. The seminar information will be based on the Australian dietary guidelines, the physical activity and exercise guidelines for Australians, the Australian clinical guidelines for the management of acute coronary syndromes, and the heart foundation guidelines. Attendance to the education seminars will be assessed using an attendance checklist. If a participant is non-compliant this will be recorded.

Participants randomised to the cardiovascular rehabilitation program will continue to receive their usual care and medical advice by their local doctor or vascular surgeon.
Intervention code [1] 325351 0
Rehabilitation
Comparator / control treatment
Usual care. Participants randomised to the usual care group will continue to receive their usual care and medical advice by their local doctor or vascular surgeon.
Control group
Active

Outcomes
Primary outcome [1] 333734 0
Six-minute walk test (6MWT). Change in maximum walking distance (MWD) during the 6MWT.
Timepoint [1] 333734 0
Week 1 (baseline), week 8 (primary), and week 34 (6-month follow-up visit after completion of intervention).
Secondary outcome [1] 418094 0
Change in pain-free walking distance (PFWD) during the 6MWT.
Timepoint [1] 418094 0
Week 1 (baseline), week 8, and week 34.
Secondary outcome [2] 418095 0
Maximum walk time (MWT) measured during a graded treadmill walking test (Gardner-Skinner protocol).
Timepoint [2] 418095 0
Weeks 1 (baseline) and 8.
Secondary outcome [3] 418096 0
Pain-free walking time (PFWT) measured during a graded treadmill walking test (Gardner-Skinner protocol).
Timepoint [3] 418096 0
Weeks 1 (baseline) and 8.
Secondary outcome [4] 418097 0
Cardiorespiratory fitness measured as peak oxygen uptake during the graded treadmill walking test (Gardner-Skinner protocol).
Timepoint [4] 418097 0
Weeks 1 (baseline) and 8.
Secondary outcome [5] 418098 0
Disease specific quality of life assessed using the Intermittent Claudication Questionnaire (ICQ).
Timepoint [5] 418098 0
Weeks 1 (baseline), 8, and 34.
Secondary outcome [6] 418099 0
Self-reported walking capacity assessed using the Walking Impairment Questionnaire (WIQ).
Timepoint [6] 418099 0
Weeks 1 (baseline), 8, and 34.
Secondary outcome [7] 418101 0
Physical activity levels objectively assessed using an ActiGraph accelerometer (ActiGraph, Pensacola, FL, USA).
Timepoint [7] 418101 0
Weeks 1 (baseline), 8 and 34.
Secondary outcome [8] 418102 0
Physical activity levels assessed using the international physical activity questionnaire for elderly (IPAQ-E).
Timepoint [8] 418102 0
Weeks 1 (baseline), 8 and 34.
Secondary outcome [9] 418103 0
Ankle to brachial systolic blood pressure index (ABI) of both legs (exploratory outcome). Brachial blood pressures will be measured in the right and left arm using an automated blood pressure monitor. Systolic blood pressure of the dorsalis pedis artery (DPA) and posterior tibial artery (PTA) at the left and right ankles will also be measured using a manual cuff sphygmomanometer and handheld Doppler ultrasound probe. Measurements will be made in the following standardised order in triplicate: Left brachial, Rright DPA, Left DPA, Right brachial, Left PTA, Right PTA. The average of the closest two recordings at each artery will be recorded. The ABI for each leg will be calculated by dividing the higher DPA or PTA value by the highest brachial artery value obtained from either side.
Timepoint [9] 418103 0
Weeks 1 (baseline), 8 and 34.
Secondary outcome [10] 418104 0
Brachial artery flow-mediated dilation assessment measured in response to reactive hyperaemia in the forearm (exploratory outcome). A cuff will be placed around the forearm and inflated to 200 mmHg for 5 minutes. Upon release, change in brachial artery diameter and blood velocity will be recorded with a multi-frequency linear array probe, attached to a high resolution ultrasound machine.
Timepoint [10] 418104 0
Weeks 1 (baseline), 8 and 34.
Secondary outcome [11] 418107 0
Arterial stiffness measured with carotid-femoral artery pulse wave velocity (exploratory outcome). For the pulse wave velocity assessment a hand-held tonometer probe will be held against the skin surface over the carotid artery to obtain carotid artery pulse waves, and a pressure cuff will be placed around the upper thigh to record femoral artery pulse waves. The distance from the carotid site above to the proximal edge of a thigh cuff over the femoral artery (midway between the hip and the knee) will be measured using a tape measure over the body area. The carotid and femoral pulse waves will be recorded simultaneously, and the femoral pulse wave requires the thigh cuff to be partially inflated. The pulse wave velocity will then be automatically calculated as the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. Pulse wave velocity will be recorded as the average of triplicate measurements.
Timepoint [11] 418107 0
Weeks 1 (baseline), 8, and 34.
Secondary outcome [12] 418108 0
Arterial stiffness measured with augmentation index (exploratory outcome). For the augmenation index assessment, brachial artery pulse waves will be obtained by partially inflating a cuff over the brachial artery using a SphygmoCor system.
Timepoint [12] 418108 0
Weeks 1 (baseline), 8, and 34.
Secondary outcome [13] 418109 0
Markers of cardiovascular disease risk (cholesterol, triglycerides, high-density lipoprotein, low density lipoprotein, haemoglobin A1c) assessed through medical records of participants (exploratory outcome).
Timepoint [13] 418109 0
Weeks 1 (baseline) and 34.

Eligibility
Key inclusion criteria
1. Adult (18 years old or greater) with a formal diagnosis of PAD by a vascular surgeon.
2. Have had lower limb revascularisation procedure (i.e., angioplasty, bypass, hybrid) in the previous 12 months.
3. Clearance and approval to participate from the treating vascular surgeon, including verification that the patient has adequately recovered from any recent (< 6 weeks) lower limb revascularisation procedure.
4. Able to understand and communicate in English sufficient to complete the informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to walk independently.
2. Previous lower limb amputation or current tissue necrosis (ulceration or gangrene) that limits the ability to undertake walking tests.
3. Deemed not eligible to particate in cardiovascular rehabilitation for reasons such as: unstable angina, acute heart failure, recent cerebrovascular event, uncontrolled resting hypertension (resting SBP > 180mmHg, resting DBP > 100mmHg), uncontrolled diabetes, symptomatic hypotension, uncontrolled sinus tachycardia (> 100bpm), uncontrolled/complex arrythmias. Eligibility for cardiovascular rehabilitation will be determined by the cardiovascular rehabilitation clinical staff as per standard clinical guidelines.
4. Currently participating in a supervised exercise rehabilitation program.
5. Terminal illness or other medical condition or planned treatment that may affect the ability to participate or complete the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be ensured using a centralised computer allocation service (SealedEnvelope.com).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur after the baseline outcome measures (i.e.,visit 3). Randomisation will be generated using a secure, independent web-based randomisation system (SealedEnvelope.com). Prior to randomisation, participants will be stratified to account for type of procedure (e.g., open vs endovascular procedure) and time since procedure (< 12 weeks vs > 12 weeks). Randomisation will be in a 1:1 ratio and randomisation blocks of 2-4 participants will be used to ensure equal group numbers throughout the recruitment and enrolment period.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Saving Legs and Lives trial is a single centre, prospective, parallel-group, randomised-controlled study that compares the efficacy of a 6-week cardiovascular rehabilitation program with usual care in people who have undergone lower limb revascularisation for peripheral artery disease. All eligible participants will continue to receive usual care and medical advice from their local doctor and vascular surgeon, and they will be randomly allocated to a community-based cardiovascular rehabilitation program (intervention) or usual care (control) for 6 weeks. Outcome measures will be assessed at baseline (week 1), after the completion of the cardiovascular rehabilitation program / usual care period (week 8), and again 6 months after the completion of the program (week 34).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous studies that assessed the effects of post-revascularisation exercise therapy indicated a potential effect of 53.2 m with a standard deviation of 81 m for 6-minute walk test distance. This would provide a medium effect size of 0.65. To establish this effect from baseline to week 8 with 80% power and an alpha 0.05, 30 participants would be required in each group. Allowing for 10% dropout, 33 participants will be recruited in each group (total N =66).

Data will be analysed using IBM SPSS 25.0 software (SPSS Inc, Chicago, IL). Data will be tested for normality using the Shapiro-Wilk test and will be considered normally distributed when P > 0.05. Analyses will be conducted using analysis of variance (ANOVA). The primary comparison will be 6 weeks cardiovascular rehabilitation versus usual care at week 8 timepoint. Additional analyses will be performed from baseline to week 34. As required, confounding variables (including comorbidities, age, sex, smoking behaviour, medications) will be adjusted for using analysis of covariance (ANCOVA). In all analyses, P < 0.05 will be, a priori, considered statistically significant. Post-hoc analysis will be performed when a significant effect is present.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/04/2024
Actual
2/04/2024
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
2/02/2026
Actual
Sample size
Target
66
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23908 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 23911 0
The Sunshine Coast Private Hospital - Buderim
Recruitment postcode(s) [1] 39393 0
4575 - Birtinya
Recruitment postcode(s) [2] 39396 0
4556 - Buderim

Funding & Sponsors
Funding source category [1] 313115 0
University
Name [1] 313115 0
University of the Sunshine Coast
Country [1] 313115 0
Australia
Funding source category [2] 313122 0
Hospital
Name [2] 313122 0
Sunshine Coast Health Institute which is part of Sunshine Coast Hospital and Health Service
Country [2] 313122 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
90 Sippy Downs Dr, Sippy Downs QLD 4556 Australia.
Country
Australia
Secondary sponsor category [1] 314823 0
None
Name [1] 314823 0
Address [1] 314823 0
Country [1] 314823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312364 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 312364 0
Ethics committee country [1] 312364 0
Australia
Date submitted for ethics approval [1] 312364 0
01/03/2023
Approval date [1] 312364 0
11/04/2023
Ethics approval number [1] 312364 0
REC/2023/MNHB/94155
Ethics committee name [2] 312410 0
University of the Sunshine Coast (UniSC HREC)
Ethics committee address [2] 312410 0
Ethics committee country [2] 312410 0
Australia
Date submitted for ethics approval [2] 312410 0
13/11/2023
Approval date [2] 312410 0
17/11/2023
Ethics approval number [2] 312410 0
S231914

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124394 0
Prof Christopher Askew
Address 124394 0
University of the Sunshine Coast, School of Health.
90 Sippy Downs Drive, Sippy Downs QLD 4556 Australia.
Country 124394 0
Australia
Phone 124394 0
+61 412 332 987
Fax 124394 0
Email 124394 0
caskew@usc.edu.au
Contact person for public queries
Name 124395 0
Krist Feka
Address 124395 0
University of the Sunshine Coast, School of Health.
90 Sippy Downs Drive, Sippy Downs QLD 4556 Australia.
Country 124395 0
Australia
Phone 124395 0
+61 421 316 813
Fax 124395 0
Email 124395 0
krist.feka@research.usc.edu.au
Contact person for scientific queries
Name 124396 0
Christopher Askew
Address 124396 0
University of the Sunshine Coast, School of Health.
90 Sippy Downs Drive, Sippy Downs QLD 4556 Australia.
Country 124396 0
Australia
Phone 124396 0
+61 412 332 987
Fax 124396 0
Email 124396 0
caskew@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only investigators and study staff involved in the collection and analysis of the data will have access to (de-identifiable) participant data. Participant data will not be shared with other research groups.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18240Study protocol  caskew@usc.edu.au



Results publications and other study-related documents

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