Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000110987
Ethics application status
Approved
Date submitted
23/01/2020
Date registered
7/02/2020
Date last updated
16/11/2023
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The IDEAL-EX Project: Ideal Exercise for Cardiometabolic Risk in Older Adults
Scientific title
The IDEAL-EX Project: Ideal Exercise for Cardiometabolic Risk in Older Adults
Secondary ID [1] 300113 0
None
Universal Trial Number (UTN)
U1111-1245-5753
Trial acronym
IDEAL-EX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiometabolic Risk 315646 0
Condition category
Condition code
Cardiovascular 313934 313934 0 0
Hypertension
Metabolic and Endocrine 313935 313935 0 0
Metabolic disorders
Physical Medicine / Rehabilitation 313936 313936 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The IDEAL-EX Project will compare the effect of combined high-intensity interval training (HIIT) and progressive resistance training (PRT) against HIIT alone for improving cardiometabolic risk factors in older adults, over 12 weeks of exercise. Both groups will attend UNSW Sydney Exercise Physiology department and receive individually supervised exercise sessions, 3 non-consecutive days a week over 12 weeks by an Accredited Exercise Physiologist with at least 5 years experience. The HIIT+PRT group will perform 20 minutes of HIIT, as outlines below, including warm up and cool down, followed by 4 high-intensity PRT exercises (approximately 30 minutes as outlined below). The HIIT group will perform 20 minutes of HIIT, including warm up and cool down, and be instructed to avoid PRT during the intervention.

Interventions
Frequency: 3 training sessions per week, non-consecutive days (Monday, Wednesday, Friday)

HIIT:
Intensity: Warm-up and cool-down 50-60% peak heart rate (PHR), Interval=85-95%PHR, Rest ~70%PHR
Type: Cycle ergometer
Time: 20 min (Warm-up: 4 min, Intervals: 2x4min, Recovery: 2x3min, Cool-down: 2 min)
Progression: Commence the 1st exercise session in Week 1 with only 1 interval at 75%PHR. From the 2nd exercise session onwards, the 2nd interval will be added and maintained. Intensity progressed by 5% resistance or Rate of Perceived Exertion (RPE) each session to ensure 85-95%PHR attained.
Volume for HIIT: HIIT (frequency x intensity x time)

PRT
Type: Power training. Pin-loaded weight plate machines. Leg press, leg curl, seated row, chest press
Intensity: 80% 1 Repetition Maximum (1RM)
Volume: 3 x 8 Repetitions
Pattern: Fast concentric and slow eccentric phase. Rest 1 min between sets
Time: Approx 30 min
Progression: Commence 50%1RM wk 1, session 1. Intensity progressed by 10% each session over 4 sessions until 80%1RM is reached. 1RM testing repeated fortnightly to assess progress and intensity adjusted accordingly.
Volume for PRT: PRT (sets x reps x days)

Rate of Perceived Exertion (RPE) = 8/10 will also be used to assist in adherence to 80%1RM PRT intensity protocol, as well as the HIIT training intensity. Participants adherence to the desired intervention intensity will be monitored and recorded by the supervising Accredited Exercise Physiologist as sessions attended per week, intensity achieved and session duration per session. Heart rate and blood pressure (BP) will be continuously monitored (second by second heart rate monitor, data recorded every minute with BP recorded every 3-5 minutes) during HIIT sessions. Resting measures will also be recorded before and after each exercise session.
Intervention code [1] 316388 0
Prevention
Intervention code [2] 316389 0
Rehabilitation
Intervention code [3] 316390 0
Lifestyle
Comparator / control treatment
HIIT intervention group (Active comparator)
Frequency: 3 training sessions per week, non-consecutive days (Monday, Wednesday, Friday)
Intensity: Warm-up and cool-down 50-60% peak heart rate (PHR), Interval=85-95%PHR, Rest ~70%PHR
Time: 20 min
Warm-up: 4 min
Intervals: 2x4min
Recovery: 2x3min
Cool-down: 2 min
Type: Cycle ergometer
Volume: HIIT (frequency x intensity x time)
Progression HIIT: Commence the 1st exercise session in Week 1 with only 1 interval at 75%PHR. From the 2nd exercise session onwards, the 2nd interval will be added and maintained. Intensity progressed by 5% each session until 85-95%PHR attained.
Progress revolutions per minute (RPM) or resistance when required to ensure desired PHR achieved.
Control group
Active

Outcomes
Primary outcome [1] 322328 0
Muscle strength
The primary outcome is the difference in muscle strength between groups at the end of the intervention period. Lower limb muscular strength will be assessed via a 1 repetition maximum (RM) leg press and knee extension on a pin-loaded machine, with maximum loads lifted added together for lower limb strength. Upper limb strength will be assessed via a 1RM seated row and chest press pin-loaded machine, with maximum loads lifted added together for upper body strength. This is a composite primary outcome of whole body strength, which will be calculated by adding the lower body and upper body 1RM strength measures together. Handgrip strength will also be assessed using a dynamometer. These exercise tests will be repeated at baseline sessions 1 and 2 (at least 2 days apart) to account for the learning effect evident in muscle strength testing and the highest value used to represent baseline strength in analysis.
Timepoint [1] 322328 0
Whole body muscle strength will be assessed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13). Measurements will also be repeated fortnightly for progression of the intervention, but these measures won’t be used as outcomes.
Primary outcome [2] 322767 0
Handgrip strength
The primary outcome is the difference in handgrip strength between groups at the end of the intervention period. This be assessed using a handgrip dynamometer.
Timepoint [2] 322767 0
Hand Grip strength will be assessed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13). Measurements will also be repeated fortnightly for progression of the intervention, but these measures won’t be used as outcomes.
Secondary outcome [1] 378117 0
Cardiorespiratory fitness.
Cardiorespiratory fitness, measured as peak aerobic capacity (VO2peak in ml/min/kg), will be assessed by a validated maximal graded cycling exercise test on a cycle ergometer with a Medgraphics metabolic cart and electrocardiograph, conducted by an AEP.
Timepoint [1] 378117 0
Cardiorespiratory fitness will be assessed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [2] 378119 0
Body Mass Index (BMI)
Weight will be measured using a digital scale with the person fasting, barefoot and dressed only in underwear and a surgical gown. The gown will be weighted and the weight of which will be subtracted from the person's body weight. Height will be measured using a SECA wall mounted statiometer with the person barefoot and in the hospital gown. BMI will then be calculated using the following formula: weight (kg) divided by height (in metres) squared.
Timepoint [2] 378119 0
BMI will be assessed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [3] 378120 0
Waist Circumference.
Waist circumference will be measured in cm according to International Diabetes Federation/American Heart Association (IDF/AHA) guidelines, midway between the lowest ribs and the iliac crest.
Timepoint [3] 378120 0
Waist circumference will be assessed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [4] 378121 0
Body Composition (adipose/visceral fat distribution and lean muscle mass)
Body composition will be assessed via Dual-energy X-ray absorptiometry (DXA) measured in both kg and % total body mass.
Timepoint [4] 378121 0
Body Composition (adipose/visceral fat distribution and lean mass) will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).
Secondary outcome [5] 378122 0
Blood Pressure.
Resting blood pressure will be assessed via a validated automated sphygmomanometer; exercising blood pressure will be measured during the VO2peak exercise test at 3-minute intervals by a Finapres.
Timepoint [5] 378122 0
Resting blood Pressure will be taken prior to each exercise session to ensure participant safety. It will also be assessed as an outcome at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [6] 378123 0
Total Cholesterol
Venous blood samples will be collected at baseline Week -1 and post-test Week 13, aliquoted for plasma, stored at UNSW at -80°C awaiting analysis of all samples together by the Beckman Coulter AU480 Chemistry Analyser at completion of the trial. Baseline Week-1, Week 6 and Week 13 finger prick blood sample will be analysed by the Cardiochek PA Analyser. Total cholesterol will be measured in mmol/L.
Timepoint [6] 378123 0
Total Cholesterol will be assessed via venous blood sampling at baseline (week -1) and week 13. Finger prick testing using the Cardiocheck will be completed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [7] 378124 0
Low-density lipoprotein cholesterol (LDL-C)
Venous blood samples will be collected at baseline Week -1 and post-test Week 13, aliquoted for plasma, stored at UNSW at -80°C awaiting analysis of all samples together by the Beckman Coulter AU480 Chemistry Analyser. Baseline Week-1, Week 6 and Week 13 finger prick blood sample will be analysed by the Cardiochek PA Analyser. LDL-C will be measured in mmol/L.
Timepoint [7] 378124 0
LDL-C will be assessed via venous blood sampling at baseline (week -1) and week 13. Finger prick testing using the Cardiocheck will be completed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [8] 378125 0
High-density lipoprotein cholesterol (HDL-C)
Venous blood samples will be collected at baseline Week -1 and post-test Week 13, aliquoted for plasma, stored at UNSW at -80°C awaiting analysis of all samples together by the Beckman Coulter AU480 Chemistry Analyser. Baseline Week-1, Week 6 and Week 13 finger prick blood sample will be analysed by the Cardiochek PA Analyser. HDL-C will be measured in mmol/L.
Timepoint [8] 378125 0
HDL-C will be assessed via venous blood sampling at baseline (week -1) and week 13. Finger prick testing using the Cardiocheck will be completed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [9] 378126 0
Triglycerides
Venous blood samples will be collected at baseline Week -1 and post-test Week 13, aliquoted for plasma, stored at UNSW at -80°C awaiting analysis of all samples together by the Beckman Coulter AU480 Chemistry Analyser. Baseline Week-1, Week 6 and Week 13 finger prick blood sample will be analysed by the Cardiochek PA Analyser. Triglycerides will be measured in mmol/L.
Timepoint [9] 378126 0
Triglycerides will be assessed via venous blood sampling at baseline (week -1) and week 13. Finger prick testing using the Cardiocheck will be completed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [10] 378127 0
Fasting blood glucose
Venous blood samples will be collected at baseline Week -1 and post-test Week 13, aliquoted for plasma, stored at UNSW at -80°C awaiting analysis of all samples together by the Beckman Coulter AU480 Chemistry Analyser. Baseline Week -1, Week 6 and Week 13 finger prick blood sample will be analysed by the Cardiochek PA Analyser. Fasting blood glucose will be measured in mmol/L.
Timepoint [10] 378127 0
Fasting blood glucose will be assessed via venous blood sampling at baseline (week -1) and week 13. Finger prick testing using the Cardiocheck will be completed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13).
Secondary outcome [11] 378128 0
Pulse wave velocity
The difference in arterial stiffness, measured by pulse wave velocity in m/s. Pulse wave velocity will be assessed with the SphygmoCor pulse wave analysis system while the participant is lying supine on a bed. Blood pressure will be taken in the arm and then the pressure sensor will be placed on the carotid, radial, femoral and dorsalis pedis arteries to obtain the pulse wave velocity data.
Timepoint [11] 378128 0
Pulse wave velocity will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).
Secondary outcome [12] 378129 0
Cardiovascular Disease risk will be calculated using the ASCVD Risk Estimator Plus (http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) will be used to estimate patient’s 10-year ASCVD risk. The calculator uses the following information: Current Age (years), Sex (male/female), Race (White/African American/Other), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Total Cholesterol (mg/dL), HDL Cholesterol (mg/dL), LDL Cholesterol (mg/dL), History of Diabetes (Yes/No), Smoker (Current/Former/Never), On Hypertension Treatment (Yes/No), On a Statin (Yes/No) and On Aspirin Therapy (Yes/No).
Timepoint [12] 378129 0
ASCVD Risk will be calculated at baseline (week -1) and week 13 using venous blood samples. ASCVD Risk will also be calculated at baseline (week -1), week 6 and week 13 using
finger prick blood testing analysed using Cardiochek.
Secondary outcome [13] 378130 0
Perceived Physical Activity
The Active Australia Survey will be used to assess perceived participation in various types of physical activity as well as establishing awareness of current public health messages about physical activity.
Timepoint [13] 378130 0
Active Australia Survey will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).
Secondary outcome [14] 378131 0
Quality of life
Quality of life (including 8 sub scales of physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) will be assessed using the Short Form (SF)36 v2 Survey.
Timepoint [14] 378131 0
SF36 will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).
Secondary outcome [15] 378132 0
Physical Activity Enjoyment
The enjoyment of physical activity will be measured using the physical activity enjoyment scale.
Timepoint [15] 378132 0
Physical activity enjoyment will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).
Secondary outcome [16] 378133 0
Self-Efficacy
Ewart’s Physical Exercise Self-Efficacy Scale will be used to assess self-efficacy.
Timepoint [16] 378133 0
Self-efficacy will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).
Secondary outcome [17] 378134 0
Exercise Mood
Mood at initiation, midway and immediately post exercise, will be measured with the Feeling Scale.
Timepoint [17] 378134 0
Mood during exercise testing (VO2peak and 1RM tests) will be assessed at 3 time points: baseline (week -1), midway through the intervention (week 6) and at the end of the intervention (week 13). Mood during exercise training sessions will be assessed during training sessions 1, 18 and 36.
Secondary outcome [18] 378135 0
Sleep Quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (including its subscales of 7 components).
Timepoint [18] 378135 0
Sleep quality will be assessed at 2 time points: baseline (week -1) and at the end of the intervention (week 13).

Eligibility
Key inclusion criteria
Participants will be eligible if they are 65 years or older and have two or more modifiable biological cardiometabolic disease risk factors. The following classifications/definitions of cardiometabolic disease risk factors will be used (as per the most recently updated international guidelines from the American Heart Association and International Diabetes Federation):
• Body Mass Index greater than or equal to 25.0 kg/m2
• Waist Circumference greater than or equal to 94 cm (Male); greater than or equal to 80 cm (Female) (or population-specific guidelines)
• Systolic Blood Pressure BP > 120mmHg and Diastolic Blood Pressure > 80 mmHg
• Fasting Blood Glucose greater than or equal to 5.6 mmol/L
• Total Cholesterol greater than or equal to 5.2 mmol/L
• Low-density lipoprotein cholesterol greater than or equal to 2.6 mmol/L
• High-density lipoprotein cholesterol greater than or equal to 1.0 mmol/L (Male); greater than or equal to 1.3mmol/L (Female)
• Triglyceride greater than or equal to 1.7 mmol/L
Individuals using medication for risk factor management will be identified as meeting that risk factor classification (even if levels were in normal ranges through use of pharmacotherapy).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

• Individuals with diagnosed cardiovascular disease and/or type 2 diabetes mellitus will be excluded
• Individuals will be excluded if they have current health conditions contraindicating HIIT or PRT exercise as suggested by Weston et al 2014 including:
*unstable angina pectoris
*uncompensated heart failure
*recent myocardial infarction (<4 weeks)
*recent coronary artery bypass graft or percutaneous coronary intervention (<12 months)
*heart disease that limits exercise (valvular, congenital, ischaemic and hypertrophic cardiomyopathy)
*complex ventricular arrhythmias or heart block
*severe chronic obstructive pulmonary
*cerebrovascular disease or uncontrolled peripheral vascular disease
*uncontrolled diabetes mellitus
*hypertensive patients with blood pressure >180/110 (or uncontrolled) or severe neuropathy;
*or any other condition that is deemed contraindicated to exercise.
• Participants will also excluded if they present with other unstable chronic disease including
*orthopaedic or neuromuscular conditions limiting exercise ability
*cognitive impairment
• Participants will be excluded if they have had a medication change in the 3 months preceding the study or are non-English speaking and a suitable translator is unavailable
• Furthermore individuals who have participated in structured aerobic (moderate to high intensity walking or equivalent, > 30min, 3xweek) or moderate to high intensity progressive resistance training (use of resistance training equipment including free weights and/or other forms of resistance equipment excluding theraband) in the 3 months preceding the study or are unwilling to commit to the 12 week exercise training program will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur using randomly permuted blocks generated by computer and allocation will be concealed via placement of sequential group assignments into opaque sealed envelopes prepared by an independent researcher, which will be handed to the participant for opening by Kelly McLeod after completion of baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by an independent researcher located offsite via a computer-generated randomisation scheme (www.randomization.com) after completion of baseline testing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will also be blinded to which intervention is hypothesised to be superior
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a protocol similar to ours, Stensvold et al (2010), found a 30% difference in strength between the HIIT+PRT and HIIT groups at the end of the intervention phase. This corresponded to an effect size of 0.98. Assuming this effect size with 80% power and alpha=0.05, 18 participants are needed per group to detect a difference in muscle strength between the HIIT+PRT and HIIT groups at the end of the intervention. Based on the average dropout rate of 10% for similar studies included in a recent meta-analysis (Wewege et al 2018), n = 40 is required in total (sample size: HIIT+PRT group n=20, HIIT group n=20).

No minimum number of training sessions for participant attendance will be required for their data to be eligible for analysis. All participants who complete baseline testing and randomisation will be included in the data analysis using Intention to Treat (ITT). Reasons for non-attendance and/or drop out will be collected and reported. Any adverse and/or serious adverse events will be monitored weekly, recorded and reported in the final outcome paper.

Data will be checked for normality and reported as mean and standard deviation or median and range as appropriate. Paired t-tests will be used to assess within group changes over time. Repeated measures analysis of co-variance (ANCOVA) will be used to assess difference in change scores between groups over time using SPSS, with baseline values entered as covariates. Simple linear regressions will be used to assess any associations at baseline and post intervention. Statistical significance will be set at p<0.05. Effect sizes and 95% confidence intervals will also be calculated to enable comparison of effect between groups.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28921 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 304555 0
University
Name [1] 304555 0
UNSW Sydney
Country [1] 304555 0
Australia
Primary sponsor type
Individual
Name
Dr Belinda Parmenter
Address
UNSW Sydney, High Street, Wallace Wurth Building, UNSW Kensington Campus, NSW, Australia 2052
Country
Australia
Secondary sponsor category [1] 304833 0
None
Name [1] 304833 0
Address [1] 304833 0
Country [1] 304833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304982 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 304982 0
Ethics committee country [1] 304982 0
Australia
Date submitted for ethics approval [1] 304982 0
02/09/2019
Approval date [1] 304982 0
10/12/2019
Ethics approval number [1] 304982 0
HC190714

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

Contacts
Principal investigator
Name 98854 0
Dr Belinda Parmenter
Address 98854 0
UNSW Sydney
Wallace Wurth Building, Sydney, NSW 2052
Country 98854 0
Australia
Phone 98854 0
+61 02 93858313
Fax 98854 0
Email 98854 0
[email protected]
Contact person for public queries
Name 98855 0
Kelly McLeod
Address 98855 0
UNSW Sydney
Wallace Wurth Building, Sydney, NSW 2052
Country 98855 0
Australia
Phone 98855 0
+61 02 9385 9032
Fax 98855 0
Email 98855 0
[email protected]
Contact person for scientific queries
Name 98856 0
Kelly McLeod
Address 98856 0
UNSW Sydney
Wallace Wurth Building, Sydney, NSW 2052
Country 98856 0
Australia
Phone 98856 0
+61 02 9385 9032
Fax 98856 0
Email 98856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, up until 7 years post conclusion of the trial
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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