Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000755336
Ethics application status
Approved
Date submitted
12/05/2017
Date registered
23/05/2017
Date last updated
10/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is shorter duration cardiac rehabilitation including progressive resistance training more effective than standard-care cardiac rehabilitation?
Scientific title
Does changing the duration of cardiac rehabilitation delivery from once-per-week for twelve weeks to twice-per-week for six weeks influence changes in cardiorespiratory fitness and muscular strength?
Secondary ID [1] 291833 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 303081 0
Valvular Heart Disease 303145 0
Condition category
Condition code
Cardiovascular 302539 302539 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the efficacy of a modified twice per week for six weeks cardiac rehabilitation program (intervention) with a standard-care once per for twelve weeks cardiac rehabilitation program (control treatment) on outcomes of physical and cardiac function. The intervention is described here.

Brief Name: Modified Shorter Duration Combined Training Cardiac Rehabilitation.

Procedures and Number of Times: Participants in the intervention group will complete a cardiac rehabilitation program involving two sessions per week for six weeks. One session each week will involve one-hour of exercise including a 10-minute warm-up, 25 minutes of resistance training, 15 minutes of aerobic training and a 10-minute cool-down. The resistance training will involve a combination of the following exercises depending on the participant's medical treatment: leg extension/squat/sit-to-stand, chest press, shoulder press, upright row, leg curl, calf raise, hip extension, hip flexion, cable fly and latissimus dorsi pull-down. Participants will complete five of the aforementioned resistance training exercises initially for two sets of up to 10 repetitions at 60% of their predicted one-repetition maximum with two minute rest periods between sets. The prescription will be progressed via increases in repetitions per set and then intensity. The second session each week will be according to current cardiac rehabilitation practice, except participants will complete three resistance training exercises for 15 minutes in place of a dedicated walk.

Cardiac disease related education will be provided to each participant according to standard care cardiac rehabilitation. Topics include heart disease and interventions/procedures, identifying and modifying risk factors, exercise and heart disease, self-management, medications, nutrition, emergency care, managing emotional responses to cardiac events, behaviour change, and community support services and cardiopulmonary resuscitation. Participants will attend one one-hour education session per week for six weeks. Given that standard care cardiac rehabilitation includes twelve education sessions, participants unable to attend a particular education session will be given a video-recorded copy of missed talks/discussions (where applicable) and/or physical hard-copies of applicable educational materials. Participants will be given advice to continue exercise at the conclusion of their cardiac rehabilitation program.

Materials: Aerobic exercise will be completed as a training circuit (as per standard-care cardiac rehabilitation) using a combination of treadmills, bicycle ergometers, hand pedals, small hand weights, steps, and exercise balls as well as walking outside. In the intervention group, resistance training will be completed using cable machine weights, dumbbells and an exercise bench. Individual components of exercise prescription (frequency, intensity (load), duration, type) during cardiac rehabilitation will be recorded. Pulse oximeters will be used to monitor heart rate and oxygen saturation while the Borg 6-20 Rate of Perceived Exertion Scale will be used to evaluate the participant's rate of perceived exertion. Participants will have access to educational material via a combination of group talks/discussions, video-recorded talks/discussions and physical hard-copies of educational materials.

Who: Cardiac rehabilitation sessions will be delivered by a combination of an Accredited Exercise Physiologist, experienced Cardiac Rehabilitation Coordinators/Nurses, Physiotherapists and Allied Health Assistants. Different education sessions will be provided by a Cardiac Rehabilitation Coordinator/Nurse, a Cardiac Rehabilitation Physiotherapist, an occupational therapist, a pharmacist, a dietitian, a paramedic, a social worker and Heartbeat volunteers.

Mode of Delivery: The exercise sessions will be delivered face-to-face predominantly in a group setting. A rolling recruitment will be employed, therefore between 1-15 study participants are expected to be completing cardiac rehabilitation in any given session.

Location: The intervention will be delivered in the outpatient cardiac rehabilitation clinic of a publicly funded hospital.

Adherence: Adherence will be monitored by the Cardiac Rehabilitation Coordinators/Nurses, Physiotherapists and Accredited Exercise Physiologist involved with the study. The exercise sheets used in the study will be dated for every session that a participant attends cardiac rehabilitation, which will then be used to monitor attendance and compliance with the exercise prescription.
Intervention code [1] 297973 0
Treatment: Other
Intervention code [2] 297974 0
Rehabilitation
Comparator / control treatment
This study will compare the efficacy of a modified twice per week for six weeks cardiac rehabilitation program (intervention) with a standard-care once per for twelve weeks cardiac rehabilitation program (control treatment) on outcomes of physical and cardiac function. The control treatment is described here.

Brief Name: Standard-Care Cardiac Rehabilitation.

Procedures and Number of Times: Participants in the control treatment will attend and complete cardiac rehabilitation according to standard care as it is currently delivered, one day per week for 12 week. This has an aerobic exercise focus, with light resistance exercises included as part of the exercise designed to increase participant's heart rate and cardiac output.

Cardiac disease related education will be provided to each participant according to standard care cardiac rehabilitation. Topics include heart disease and interventions/procedures, identifying and modifying risk factors, exercise and heart disease, self-management, medications, nutrition, emergency care, managing emotional responses to cardiac events, behaviour change, and community support services and cardiopulmonary resuscitation. Participants will be given advice to continue exercise at the conclusion of their cardiac rehabilitation program.

Materials: Standard-care cardiac rehabilitation exercise sessions involves the use of a combination of treadmills, bicycle ergometers, hand pedals, small hand weights, steps, and exercise balls as well as walking outside. Individual components of exercise prescription (frequency, intensity (load), duration, type) during cardiac rehabilitation will be recorded. Pulse oximeters will be used to monitor heart rate and oxygen saturation while the Borg 6-20 Rate of Perceived Exertion Scale will be used to evaluate the participant's rate of perceived exertion. Participants will attend group educational talks/discussions.

Who: Cardiac rehabilitation sessions will be delivered by a combination of Cardiac Rehabilitation Coordinators/Nurses, Physiotherapists and Allied Health Assistants. Different education sessions will be provided by a Cardiac Rehabilitation Coordinator/Nurse, a Cardiac Rehabilitation Physiotherapist, an occupational therapist, a pharmacist, a dietitian, a paramedic, a social worker and Heartbeat volunteers.

Mode of Delivery: The exercise sessions will be delivered face-to-face predominantly in a group setting. A rolling recruitment will be employed, therefore between 1-15 study participants are expected to be completing cardiac rehabilitation in a given session.

Location: The control treatment will be delivered in the outpatient cardiac rehabilitation clinic of a publicly funded hospital.

Adherence: Adherence will be monitored by the Cardiac Rehabilitation Coordinators/Nurses and Physiotherapists involved with the study. The exercise sheets used in the study will be dated for every session that a participant attends cardiac rehabilitation, which will then be used to monitor attendance and compliance with the exercise prescription.
Control group
Active

Outcomes
Primary outcome [1] 301996 0
Peak oxygen consumption assessed using respiratory gas analysis during a symptom-limited peak exercise capacity bicycle test.
Timepoint [1] 301996 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Primary outcome [2] 301997 0
Estimated 1-repetition maximum using a repetitions-to-fatigue testing protocol (up to 10 repetitions) using a previously validated equation for the chest press and leg press exercises.
Timepoint [2] 301997 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [1] 334487 0
Stature assessed using International Society for the Advancement of Kinanthropometry technique.
Timepoint [1] 334487 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [2] 334488 0
Body mass assessed using International Society for the Advancement of Kinanthropometry technique.
Timepoint [2] 334488 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [3] 334489 0
Waist circumference assessed using International Society for the Advancement of Kinanthropometry technique.
Timepoint [3] 334489 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [4] 334490 0
Neck circumference assessed using International Society for the Advancement of Kinanthropometry technique.
Timepoint [4] 334490 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [5] 334491 0
Body fat mass assessed using bio-electrical impedance.
Timepoint [5] 334491 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [6] 334492 0
Body fat-free mass assessed using bio-electrical impedance.
Timepoint [6] 334492 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [7] 334493 0
Body fat percentage assessed using bio-electrical impedance.
Timepoint [7] 334493 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [8] 334494 0
Handgrip strength assessed using a handgrip dynamometer.
Timepoint [8] 334494 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [9] 334855 0
Functional lower body muscle strength assessed using the 5-times sit-to-stand test.
Timepoint [9] 334855 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [10] 334856 0
Standard deviation of N-N intervals (SDNN) during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [10] 334856 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [11] 334857 0
Root Mean Square of Successive Differences (r-MSSD) during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [11] 334857 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [12] 334858 0
Proportion of number of pairs of consecutive N-N intervals that differ by more than 50ms (pNN50) during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [12] 334858 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [13] 334859 0
Number and proportion of N-N intervals in Ultra Low Frequency HRV band during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [13] 334859 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [14] 334860 0
Number and proportion of N-N intervals in Very Low Frequency HRV band during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [14] 334860 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [15] 334861 0
Number and proportion of N-N intervals in Low Frequency HRV band during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [15] 334861 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [16] 334862 0
Number and proportion of N-N intervals within High Frequency HRV band assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [16] 334862 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [17] 334863 0
The logarithm of (the number of N-N intervals in Low Frequency HRV band divided by the number of N-N intervals in High Frequency HRV band) during a 24-hour period assessed using a Holter Monitor. Participants will wear a Holter Monitor for 24 hours.
Timepoint [17] 334863 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [18] 334864 0
Vascular compliance assessed using pulse-wave analysis and pulse-wave velocity techniques.
Timepoint [18] 334864 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [19] 334865 0
Quality of life using the Mac New Quality of Life in Heart Disease questionnaire.
Timepoint [19] 334865 0
Baseline, and during week-7, week-13, week-19 and week-31 of the protocol.
Secondary outcome [20] 334866 0
Change in daily and weekly energy intake assessed by completing food/activity diaries for seven days.
Timepoint [20] 334866 0
During the first week of cardiac rehabilitation and during week-6, week-12, week-18 and week-30 of the protocol.
Secondary outcome [21] 334870 0
Change in macronutrient content of meals assessed by completing food/activity diaries for seven days.
Timepoint [21] 334870 0
During the first week of cardiac rehabilitation and during week-6, week-12, week-18 and week-30 of the protocol.
Secondary outcome [22] 334871 0
Change in daily and weekly physical activity levels assessed by wearing an accelerometer and completing food/activity diaries for seven days.
Timepoint [22] 334871 0
During the first week of cardiac rehabilitation and during week-6, week-12, week-18 and week-30 of the protocol.
Secondary outcome [23] 334872 0
Change in daily and weekly energy expenditure assessed by wearing an accelerometer and completing food/activity diaries for seven days.
Timepoint [23] 334872 0
During the first week of cardiac rehabilitation and during week-6, week-12, week-18 and week-30 of the protocol.

Eligibility
Key inclusion criteria
Male and female patients that have recently experienced an acute cardiac event and are eligible for outpatient cardiac rehabilitation. This typically involves patients who have recently undergone coronary artery bypass graft surgery, a cardiac valve repair/replacement, atrial septal defect/ventricular septal defect and other cardiac surgeries, electrocardiogram detected cardiac events, percutaneous coronary interventions, or medical management of an acute cardiac condition.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria include patients over the age of 80 years, children and pregnant women, patients with unstable cardiac disease, and significant cognitive impairments or understanding of the English language that limit understanding of the study.

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 achieved by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked randomisation plan will be generated electronically and stratified by gender by a person not involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The participants will know how frequently they are attending cardiac rehabilitation but will be blinded to the actual exercise prescription.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size for the study was determined using A priori, two groups, two-tailed, power analyses based off change in peak oxygen consumption and muscular strength determined by one-repetition maximum in previously published studies using a 7-week and 10-week combined training versus aerobic training alone (assumed to be synonymous with the standard-care cardiac rehabilitation program in this study) study design. Data from 7-week and 10-week study designs were used to closely match the 6-week (length of intervention) and 12-week (length of control treatment) outcome measurements. Observed effect sizes of 0.86 for peak oxygen consumption and 0.75 for muscular strength in favour of combined training with an alpha error of 0.05 and at 80% power determined sample sizes of 46 and 58 respectively for a 7-week study design. Observed effect sizes of 0.68 for peak oxygen consumption and 0.76 for muscular strength with an alpha error of 0.05 and at 80% power determined sample sizes of 70 and 58 respectively for a 10-week study design. As such, 88 participants will be targeted for recruitment to allow for 25% attrition throughout the study after the pre-cardiac rehabilitation assessment.

Data will be assessed for normality and descriptive statistics will be used to define the population. Paired sample t-tests will be used to assess within group change in outcome measures. Independent sample t-tests will be used to compare the paired difference data between the two groups. Statistical Package for the Social Sciences software (SPSS, International Business Machines Corporation, Armonk, USA) will be used for statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
8/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7934 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 15899 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 296331 0
University
Name [1] 296331 0
La Trobe University
Country [1] 296331 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
La Trobe Rural Health School
Edwards Road
Flora Hill, Victoria, 3552
Country
Australia
Secondary sponsor category [1] 295259 0
Hospital
Name [1] 295259 0
Bendigo Health Care Group
Address [1] 295259 0
Bendigo Health Care Group
100 Barnard Street
Bendigo, Victoria, 3550
Country [1] 295259 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297561 0
Bendigo Health Care Group Human Research Ethics Committee
Ethics committee address [1] 297561 0
CHERC
Level 3, Anne Caudle Centre Campus
110 Barnard St
Bendigo, Victoria, 3550
Ethics committee country [1] 297561 0
Australia
Date submitted for ethics approval [1] 297561 0
Approval date [1] 297561 0
27/02/2017
Ethics approval number [1] 297561 0
HREC/16/BHCG/67
Ethics committee name [2] 297588 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 297588 0
Ethics and Integrity
Research Office
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, Victoria, 3086
Ethics committee country [2] 297588 0
Australia
Date submitted for ethics approval [2] 297588 0
Approval date [2] 297588 0
09/03/2017
Ethics approval number [2] 297588 0

Summary
Brief summary
This study will investigate the efficacy of a modified shorter duration (6-week) combined training-based cardiac rehabilitation program on functional capacity (physical and cardiac function) versus a standard-care longer duration (12-week) cardiac rehabilitation program. Combined training refers to an intervention combining progressive resistance training with aerobic training. Previous meta-analyses have shown that combined training is superior to aerobic training alone for enhancing physical function and that improvements in physical function are enhanced over a shorter duration in this population. However, whether the improvements in physical function are comparable between a shorter-duration (6-week) combined training cardiac rehabilitation program and a standard-care longer duration (12-week), aerobic-based, cardiac rehabilitation program is unknown.

Project Aims:
The overarching aim of this study is to compare the efficacy of a modified shorter duration cardiac rehabilitation program to a standard-care longer duration cardiac rehabilitation program on functional capacity (physical and cardiac function). It is expected that this study will provide important information on the efficacy of shorter duration combined training-based cardiac rehabilitation programs, potentially a superior model than standard-care longer duration cardiac rehabilitation.

Research Design and Methods:
Participants in this study will be recruited as outpatients, who have recently experienced an acute cardiac event, and have been referred to outpatient cardiac rehabilitation. Participants will undergo a standard nursing assessment from cardiac rehabilitation staff to be cleared for exercise before participating in this study. Participants will undergo baseline testing before being randomised to complete either a modified shorter duration (6-week) combined training cardiac rehabilitation program or the standard-care longer duration (12-week) cardiac rehabilitation program. Participants will undergo follow-up testing at 7-weeks, 13-weeks, 19-weeks and 31-weeks into the protocol. Tests include anthropometric measurements, aerobic capacity, muscle strength, heart rate variability, vascular compliance, body composition, quality of life, and physical activity monitoring. Adherence and compliance to cardiac rehabilitation will also be monitored. Within each group, changes in the aforementioned outcome measures will be analysed from baseline, before cardiac rehabilitation, to the conclusion of cardiac rehabilitation and at two extended follow-up time-points. Changes in the outcome measures will also be analysed between the two groups.
Trial website
Trial related presentations / publications
Public notes
Funding from La Trobe University for this work included funding from the La Trobe University Sport, Exercise and Rehabilitation Research Focus Area and a La Trobe University Postgraduate Research Scholarship.

This work was supported by an Australian Government Research Training Program Scholarship.

Contacts
Principal investigator
Name 74446 0
A/Prof Michael Kingsley
Address 74446 0
La Trobe University
La Trobe Rural Health School
Edwards Road
Flora Hill, Victoria, 3552
Country 74446 0
Australia
Phone 74446 0
+61 3 5444 7589
Fax 74446 0
Email 74446 0
[email protected]
Contact person for public queries
Name 74447 0
Mr Paul Xanthos
Address 74447 0
La Trobe University
La Trobe Rural Health School
Edwards Road
Flora Hill, Victoria, 3552
Country 74447 0
Australia
Phone 74447 0
+61 3 5444 7316
Fax 74447 0
Email 74447 0
[email protected]
Contact person for scientific queries
Name 74448 0
A/Prof MIchael Kingsley
Address 74448 0
La Trobe University
La Trobe Rural Health School
Edwards Road
Flora Hill, Victoria, 3552
Country 74448 0
Australia
Phone 74448 0
+61 3 5444 7589
Fax 74448 0
Email 74448 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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