Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001393347
Ethics application status
Approved
Date submitted
27/09/2017
Date registered
3/10/2017
Date last updated
27/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
SPRINT HEART: Study of Progressive Resistance and INterval Training in HEART disease
Scientific title
SPRINT HEART: Study to evaluate the effect of Progressive Resistance and INterval Training on aerobic capacity and muscular strength in patients with coronary HEART disease: A Randomised Controlled Trial of Novel Exercise Prescription in Cardiac Rehabilitation
Secondary ID [1] 292989 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPRINT HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 304893 0
Cardiac Rehabilitation 304894 0
Condition category
Condition code
Cardiovascular 304215 304215 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 304216 304216 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible and consenting patients will be allocated to one of three study arms; high-intensity progressive-resistance training (PRT), high-intensity aerobic interval training (HIT) or standard medical care (SMC, control). The intervention period is 12 weeks in duration and training will be 3 times per week for approximately 60 minutes at the Faculty of Health Sciences Cumberland campus (Lidcombe). Training will be supervised by a postgraduate exercise physiology student, and initial sessions will also be supervised by the study physician. Session adherence and compliance to the exercise prescription will also be monitored and recorded by the postgraduate exercise physiology student. Participants will be contacted following any missed sessions, to encourage their attendance at subsequent training sessions.

Progressive-resistance training: Week 1 of the intervention will include familiarisation and gradual increase in target intensity from 50, 60, 70% 1RM in each successive session. From the first session of week 2, training intensity will be set at 80% 1RM and progressed by a projected gain in strength of 3% 1RM each session, used in conjuction with Borg RPE Scale to maintain intensity at 80% 1RM. At the start of every 7th session, 1RM will be re-tested and target weight at 80% 1RM will be recalculated based on the new 1RM. Total training volume is 24 repetitions per exercise, set initially at 3 sets of 8 repetitions. However, as intensity is most important, sets and repetitions may be manipulated such that prescribed intensity is adhered to and the total volume remains 24 repetitions per exercise. Seven pneumatic resistance machines will be used and exercises will be completed in the following order; leg press, seated row, knee extension, chest press, knee flexion, tricep pushdown, hip abduction. Participants will be instructed to contract concentrically ‘as fast as possible’ and then 3-4 seconds of control through the eccentric phase. There will be 20-30 seconds of rest between repetitions and 3-5 minutes rest between sets to allow sufficient recovery of anaerobic metabolism.

Aerobic interval training: Interval training will employ the 4x4 method, as used previously in cardiac populations (Moholdt et al. 2009). The protocol consists of 8 minutes of warm up working up to 70% peak heart rate (HRpeak), followed by four 4-minute intervals at a target of 85-95% HRpeak, each separated by 3 minutes of active recovery at ~70% HRpeak. During each of the 4-minute intervals, participants will progress from 70-80% HRpeak over the first 2-minutes, to that target intensity of 85-95% HRpeak for the final 2-minutes of each interval. Following the last interval, the participant will cool down to a slow walk with no gradient for a minimum of 5 minutes, or until breathlessness has ceased. Week 1 will serve as a familiarisation period, where the time spend at the target intensity will be increased from 30, 60, 90sec. Training will take place on a treadmill, at a self-selected brisk walking or running speed, with incline adjusted for intensity. Heart rate and oxygen saturation will be continuously monitored throughout each session and rate of perceived exertion [RPE] will be recorded in the last 15 seconds of every minute of training.
Intervention code [1] 299228 0
Rehabilitation
Intervention code [2] 299229 0
Treatment: Other
Comparator / control treatment
Control group (SMC): The control group will receive standard medical care governed by their general practitioner, cardiologist and any other medical physician that they would normally see. At the completion of 12 weeks, they will then crossover and be randomised to one of the intervention arms, as previously outlined.
Control group
Active

Outcomes
Primary outcome [1] 303510 0
Aerobic Capacity measured by indirect calorimetry during a maximal treadmill exercise test (stress test) - where speed is set at habitual walking speed and gradient is increased by 2% every minute until volitional fatigue or physician termination.
Timepoint [1] 303510 0
Baseline, 12 weeks
Primary outcome [2] 303511 0
Muscular strength will be measured by maximal strength testing (one-repetition max) on each of the seven training exercises (leg press, knee extension, knee flexion, seated row, chest press, triceps pushdown, hip extension).
Timepoint [2] 303511 0
Baseline, 12 weeks
Primary outcome [3] 303537 0
Muscular endurance will be assessed on each of the seven training exercises. Testing will require the participant to complete as many repetitions as possible until volitional fatigue at an intensity of 90% 1RM
Timepoint [3] 303537 0
Baseline, 12 weeks
Secondary outcome [1] 339136 0
Ambulatory ability assessed via a 6-minute walk test
Timepoint [1] 339136 0
Baseline, 12 weeks
Secondary outcome [2] 339137 0
Functional mobility via the Short Physical Performance Battery (SPPB)
Timepoint [2] 339137 0
Baseline, 12 weeks
Secondary outcome [3] 339138 0
Standard cardiovascular heath measures heart rate and blood pressure will be assessed at rest and in a fasting condition
Timepoint [3] 339138 0
Baseline, 12 weeks
Secondary outcome [4] 339139 0
Microvascular endothelial function will be measured using non-invasive peripheral arterial tonometry (EndoPAT)
Timepoint [4] 339139 0
Baseline, 12 weeks
Secondary outcome [5] 339140 0
Cardiac electrophysiological assessment will be assessed using the ECG data during exercise stress tests, and include a range of outcomes including: QT (repolarisation), RR (rate response) and PR (atrio-ventricular nodal) dynamics; ST segment changes; Simulated 3d vector cardiography to determine the sequence and pattern of atrial, and ventricular activation.
Timepoint [5] 339140 0
Baseline, 12 weeks
Secondary outcome [6] 339145 0
Body composition, incorporating fat mass, lean mass and bone mineral density, will be measured by dual-energy x-ray absorptiometry (DXA)
Timepoint [6] 339145 0
Baseline, 12 weeks
Secondary outcome [7] 339146 0
Community ambulation will be assessed using a tri-axial accelerometer (Axivity Ltd.) that will be worn continuously for 7 days by the participants to quantify and monitor stepping and physical activity.
Timepoint [7] 339146 0
Baseline, 12 weeks
Secondary outcome [8] 339149 0
Exercise-based self-efficacy will be measured using Bandura's Exercise Self-Efficacy and Ewarts Self-Efficacy questionnaires
Timepoint [8] 339149 0
Baseline, 12 weeks
Secondary outcome [9] 339151 0
Depressive symptoms will be measured via the Geriatric Depression Scale (GDS)
Timepoint [9] 339151 0
Baseline, 12 weeks
Secondary outcome [10] 339152 0
Current level of physical activity was measured by the Physical Activity Scale for the Elderly (PASE) and Paffenbarger questionnaire
Timepoint [10] 339152 0
Baseline, 12 weeks
Secondary outcome [11] 339153 0
Quality of Life was measured by the HEARTQoL and Short Form-36 questionnaires
Timepoint [11] 339153 0
Baseline, 12 weeks
Secondary outcome [12] 339154 0
Current level of independence was measured by the Lawton Instrumental Activities of Daily Living Scale
Timepoint [12] 339154 0
Baseline, 12 weeks
Secondary outcome [13] 339155 0
Sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [13] 339155 0
Baseline, 12 weeks
Secondary outcome [14] 339156 0
Current nutritional status was measured using the MediCul Index Tool
Timepoint [14] 339156 0
Baseline, 12 weeks
Secondary outcome [15] 339224 0
As part of the muscular fitness assessment, force-velocity profile will be assessed on each of the seven testing resistance machines. Specifically this will require two separate maximal velocity attempts at each intensity, where the participant will be asked to move the resistance as fast as possible. The intensities tested will include 35%, 45%, 55%, 65%, 75%, 85%, 95% 1RM.
Timepoint [15] 339224 0
Baseline, 12 weeks
Secondary outcome [16] 339225 0
Standard anthropometric measurements including height and weight will be assessed
Timepoint [16] 339225 0
Baseline, 12 weeks
Secondary outcome [17] 339226 0
Abdominal adiposity will be estimated using waist and hip circumference
Timepoint [17] 339226 0
Baseline, 12 weeks
Secondary outcome [18] 339227 0
Disease-specific self efficacy will be measured by the Cardiac Self Efficacy scale
Timepoint [18] 339227 0
Baseline, 12 weeks
Secondary outcome [19] 339228 0
Safety of resistance training exercises will be assessed during maximal strength testing and training sessions. This will include measurement of beat-by-beat blood pressure (Finepres), heart rate and other cardiac performance parameters (impedance cardiography)
Timepoint [19] 339228 0
Baseline, 12 weeks
Secondary outcome [20] 339229 0
Self-evaluation will be assessed by the Core Self-Evaluation questionnaire
Timepoint [20] 339229 0
Baseline, 12 weeks
Secondary outcome [21] 339230 0
Arterial stiffness will be estimated using applanation tonometry (Sphygmocor)
Timepoint [21] 339230 0
Baseline, 12 weeks
Secondary outcome [22] 339231 0
Autonomic function will be assessed using heart rate variability (Sphygmocor)
Timepoint [22] 339231 0
Baseline, 12 weeks
Secondary outcome [23] 339232 0
Resting diastolic function will be assessed by echocardiography (ultrasound)
Timepoint [23] 339232 0
Baseline, 12 weeks
Secondary outcome [24] 339233 0
Peripheral blood flow and risk of peripheral vascular disease will be assessed by ankle-brachial index pressures
Timepoint [24] 339233 0
Baseline, 12 weeks
Secondary outcome [25] 339234 0
Orthostatic hypotension as a risk of falls in older adults, will be assessed by blood pressure assessment during supine and standing positions (BP response to change of position)
Timepoint [25] 339234 0
Baseline, 12 weeks
Secondary outcome [26] 339235 0
Carotid intima media thickness will be assessed using ultrasound at rest and supine
Timepoint [26] 339235 0
Baseline, 12 weeks
Secondary outcome [27] 339236 0
Ambulatory blood pressure will be assessed by participants wearing an automatic blood pressure monitor continuously for 24hrs
Timepoint [27] 339236 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
• A recent Non-STEMI and/ or cardiac angioplasty, stent, or bypass (<4 wks)
• Free of musculoskeletal disease, neurological process or injury that would preclude planned exercise testing or training over the long term or permanently
• Able to commit to 12wks of 3/wk training at USYD
• Cognitively capable of informed consent and adherence to intervention prescription
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unstable cardiac diagnosis (e.g. malignant arrhythmia such as VTach, crescendo or resting angina, significant or progressive valvular heart disease, etc)
• Unrepaired known aortic or other aneurysm
• Ejection fraction <30% , c/w HFREF diagnosis, or NYHA CLASS III or IV CHF
• Exercise treadmill stress test severely limited by condition other than aerobic capacity (e.g., OA, PAD) –
• Hisotry of recurrent stroke or TIAs
(2 or more)
• Diagnosed cognitive or progressive neurodegenerative disorder (e.g. dementia, Parkinson's Disease, MS, etc.)
• Presence of any other disease or chronic condition that study physician deems may permanently impede safe exercise completion
• Presence of alcoholism, assessed by CAGE questionnaire and reported alcohol intake above NHMRC safe levels
• Current psychosis or suicidality

Participants may be deemed 'On Hold' and require further medical advice if they meet one of the following conditions:
• Angioplasty or. stenting (~6 wks post)
• Open heart surgery – sternum recovery (~12 wks post)
• New diagnostic finding on exercise stress test that will require specialist referral for further evaluation and follow up, including heart block, atrial fibrillation/flutter, new ST changes or q waves or other significant change in resting or exercise ECG
• New or Unstable acute or chronic disease or injury such as diabetes, COPD, hernia, rotator cuff disease, until stabilised or further evaluated

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 using concealed, sequentially numbered envelopes opened by the participant after baseline assessment completed. Sequencing and randomization will be done by an external staff member not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Control group will crossover to receive one of the treatment arms
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
An intention-to-treat analytic strategy will be used, allowing inclusion of all participants regardless of adherence or dropout without need for imputation. A mixed model analysis of covariance will be used to assess the main effects of changes over time and group x time interactions, adjusted for age, gender, baseline function and burden and other characteristics found to be related to the variable of interest.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9115 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 17615 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 297614 0
University
Name [1] 297614 0
The University of Sydney
Country [1] 297614 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Westmead Hospital
Hawkesbury Rd & Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 296629 0
University
Name [1] 296629 0
The University of Sydney
Address [1] 296629 0
Faculty of Health Sciences
East St
Lidcombe NSW 2141
Country [1] 296629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298704 0
Western Sydney Local Health District
Ethics committee address [1] 298704 0
Ethics committee country [1] 298704 0
Australia
Date submitted for ethics approval [1] 298704 0
19/07/2017
Approval date [1] 298704 0
11/10/2017
Ethics approval number [1] 298704 0
AU RED HREC/17/WMEAD/331

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

Contacts
Principal investigator
Name 77954 0
Prof Maria A. Fiatarone Singh, MD, FRACP
Address 77954 0
University of Sydney
K221, Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country 77954 0
Australia
Phone 77954 0
+61 2 9351 9755
Fax 77954 0
+61 2 9351-9204
Email 77954 0
[email protected]
Contact person for public queries
Name 77955 0
Matthew Hollings
Address 77955 0
University of Sydney
H111, Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country 77955 0
Australia
Phone 77955 0
+61 2 9036 7364
Fax 77955 0
Email 77955 0
[email protected]
Contact person for scientific queries
Name 77956 0
Maria A. Fiatarone Singh, MD, FRACP
Address 77956 0
University of Sydney
K221, Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country 77956 0
Australia
Phone 77956 0
+61 2 9351 9755
Fax 77956 0
+61 2 9351-9204
Email 77956 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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