Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001052729
Ethics application status
Approved
Date submitted
20/07/2022
Date registered
28/07/2022
Date last updated
28/07/2022
Date data sharing statement initially provided
28/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole body vibration exercise and type 2 diabetes
Scientific title
Investigating the impact of whole body vibration exercise on exercise capacity and glycaemia in type 2 diabetes
Secondary ID [1] 307591 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 327033 0
Hyperglycaemia 327034 0
Diminished exercise capacity 327035 0
Condition category
Condition code
Metabolic and Endocrine 324207 324207 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single-site two-armed, parallel, randomized controlled trial comparing the effect of 3 months of home-based vibration exercise training to usual care.

PRE-INTERVENTION TESTING:
Clinical chemistries and anthropometrics: Fasting clinical chemistries (glucose, insulin, lipid profile, HbA1c, lactate) will be measured. Medical, lifestyle, quality of life, and dietary questionnaires will be used to assess overall health, physical activity, quality of life, and dietary habits. A 6-minute walk test will be conducted to assess functional exercise capacity.

Vascular function and metabolic responses to both exercise stress testing and mixed nutrient meal ingestion will be performed before and after a 3-month intervention (home-based vibration exercise training or usual care).

Exercise Doppler-echocardiogram: Graded exercise testing will be performed on an exercise bike using standard cardiopulmonary stress equipment and symptom limited graded exercise test protocol. Resting and post-exercise echocardiographic assessment will be performed using a commercial ultrasound machine at rest and during exercise testing.

Microvascular responses in skeletal muscle during exercise and after mixed nutrient meal ingestion: Microvascular blood flow responses will be tested via contrast enhanced ultrasound imaging of thigh muscle at rest, at the end of the exercise stress tests, and during and after ingesting a mixed nutrient meal.

Large artery function and central haemodynamics: Femoral artery blood flow will be assessed using 2D and Doppler imaging at rest, at the end of the exercise stress tests, and during and after ingesting a mixed nutrient meal.

Mixed nutrient meal: Participants will be provided a mixed nutrient meal (300 Calories) to consume within 5 minutes.

Each testing session will take 2-3 hours and will be supervised by someone from the research team (cardiovascular or exercise physiologist).

WHOLE BODY VIBRATION EXERCISE INTERVENTION (3 months):
Participants will undergo whole body vibration exercise 4 days per week for 3 months. The training is designed to perform static work on the legs. Participants will stand on a commercially available platform. For the first 4 weeks, training will be carried out for 10 min per session. For weeks 5-8, training will be increased to 15 min per session. For weeks 9-12, training will be increased to 20 min per session. Participants will be loaned a platform to take home. Participants will be asked only to maintain their usual daily activities in addition to the vibration training (i.e. no additional exercise). Adherence to the intervention will be via a vibration exercise diary and contact from the research team every 2 weeks via email or phone.

MID-INTERVENTION EXERCISE TESTING (after 6 weeks):
After 6 weeks of the intervention, participants will be asked to attend a single session at Deakin University to undergo a 6-minute walk test and a maximal exercise test on a gym bike. No ultrasound measures or blood will be taken during this visit. Aerobic capacity (exercise tolerance) will be measured via a face-mask during the maximal exercise test.

POST-INTERVENTION TESTING:
Participants will repeat the same mixed meal challenge and exercise tests as performed in the pre-intervention visits. These visits will be conducted a minimum of 48 hours after the final training session to eliminate the effects of any prior exercise bout.
Intervention code [1] 324038 0
Rehabilitation
Intervention code [2] 324039 0
Lifestyle
Intervention code [3] 324091 0
Treatment: Devices
Comparator / control treatment
A usual care group will be included whom do not undergo the home-based vibration exercise intervention. Participants randomised to this group will be instructed to maintain their normal lifestyle habits, physical activity levels (whether low, moderate or high), and current treatment/medication as instructed and recommended by their GP/Health Specialist. Participants in this group will however be asked to refrain from increasing their physical activity level above from what they are currently undergoing.
Control group
Active

Outcomes
Primary outcome [1] 332043 0
Change in exercise capacity (peak volume of oxygen utilisation) assessed by metabolic cart and oxygen analyser during the graded exercise test using a stationary bike.
Timepoint [1] 332043 0
Exercise capacity (peak volume of oxygen utilisation) measured during the graded exercise test both before and after the 3-month intervention.
Primary outcome [2] 332044 0
Change in peak post-exercise microvascular blood flow measured by contrast enhanced ultrasound after the 3-month intervention.
Timepoint [2] 332044 0
Peak post-exercise microvascular blood flow measured immediately before and after the 3-month intervention.
Secondary outcome [1] 411972 0
Change in peak meal induced microvascular blood flow measured by contrast enhanced ultrasound after the 3-month intervention.
Timepoint [1] 411972 0
Peak meal-induced microvascular blood flow measured immediately before and after the 3-month intervention.
Secondary outcome [2] 411973 0
Change in distance walked (meters) during a 6-minute walk test after the 3-month intervention.
Timepoint [2] 411973 0
Distance walked (in meters) during the 6-minute walk test both before and after the 3-month intervention.
Secondary outcome [3] 412151 0
Change in blood glucose levels during the meal challenge
Timepoint [3] 412151 0
Blood samples will be taken to measure blood glucose levels. Samples will be collected at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min following consumption of the mixed meal. The glucose area under the time curve will also be calculated.
Secondary outcome [4] 412341 0
Change in cardiac index assessed by ultrasound during the graded exercise test using a stationary bike.
Timepoint [4] 412341 0
Cardiac index measured during the graded exercise test both before and after the 3-month intervention.

Eligibility
Key inclusion criteria
1. Aged 40–80 years.
2. Clinical diagnosis of type 2 diabetes
[controlled diabetes through diet or medication (excluding insulin)].
3. Weight <180kg
4. Have given signed informed consent to participate in the study.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <40 years or > 80 years.
2. Patients using insulin to control blood sugar levels.
3. Weight >180kg
4. Pulmonary hypertension.
5. Atrial fibrillation.
6. Cardiovascular disease including coronary artery disease, heart valve disease or heart failure.
7. Critical limb ischemia including peripheral artery disease or previous revascularisation or other surgical treatment for peripheral artery disease.
8. History of malignancy within past 5 years (except for non-melanoma skin cancers).
9. Identification of any medical condition requiring immediate therapeutic intervention.
10. Uncontrolled hypertension (resting brachial blood pressure =160/100 mmHg).
11. Other musculoskeletal conditions and non-cardiovascular barriers to exercise/physical activity.
12. Current or previous smoker with past 12 months.
13. Participation or intention to participate in a structured and/or supervised physical activity program during the study period.
14. History of severe liver disease.
15. Elective major surgery during the course of the study.
16. Pregnancy/lactation.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (first 4 randomisation envelopes will contain 2 usual care and 2 exercise intervention).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be checked for normality. Comparison of means between groups will be compared using analysis of variance (ANOVA) and multivariable linear regression where appropriate. Comparison of multiple means will be analysed using a two-factor repeated measures ANOVA with time (before and after exercise tests, before and after mixed meal ingestion, and before and after the intervention) as the within-subjects factor and group (usual care versus exercise trained group) as the between-subjects factor. Sub-group secondary analysis of the effects of exercise tolerance on all outcomes will be investigated (exercise tolerance will be added to the statistical model as a between subjects factor) using the pre-defined definition of exercise tolerance. Significant interaction and main effects will be explored post-hoc with corrections for multiple comparisons. All data will be reported as mean ± standard deviation and all statistical analysis will be conducted at the 95% level of significance (p = 0.05).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311860 0
Commercial sector/Industry
Name [1] 311860 0
Diabetes Australia
Country [1] 311860 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway,
Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 313334 0
None
Name [1] 313334 0
Address [1] 313334 0
Country [1] 313334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311299 0
Deakin University Human Ethics Committee
Ethics committee address [1] 311299 0
221 Burwood Highway
Burwood, VIC, 3125
Ethics committee country [1] 311299 0
Australia
Date submitted for ethics approval [1] 311299 0
Approval date [1] 311299 0
07/07/2022
Ethics approval number [1] 311299 0
2022-076

Summary
Brief summary
Reduced exercise capacity is a condition of decreased ability to perform physical exercise and is common in people with type 2 diabetes. This causes a range of problems such as fatigue, pain, nausea, breathlessness, and severe muscle cramps. Reduced exercise capacity significantly reduces quality of life making independent living difficult. We have established that poor blood flow in the smallest blood vessels (microvascular) in skeletal muscle, and not problems with the heart, is the main driver of impaired exercise capacity in type 2 diabetes. We have also demonstrated that people with type 2 diabetes have poor blood glucose (glycaemic) responses to meals which is at least in part due to impairments in microvascular responses in skeletal muscle. Traditional exercise training has been demonstrated to improve exercise capacity and glycaemic regulation. Although effective, traditional exercise programs are not widely used to treat type 2 diabetes because most patients cannot or choose not to participate despite the recognised benefits. Other “exercise mimetic” vascular therapies are therefore required to assist people with type 2 diabetes. One promising novel approach is whole body vibration exercise. We will investigate whether home-based whole body vibration exercise (using a commercial vibration platform) for 3 months can improve exercise capacity and glycaemic regulation in people with type 2 diabetes compared to usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120622 0
A/Prof Michelle Keske
Address 120622 0
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 120622 0
Australia
Phone 120622 0
+61 03 9246 8850
Fax 120622 0
Email 120622 0
Michelle.Keske@deakin.edu.au
Contact person for public queries
Name 120623 0
A/Prof Michelle Keske
Address 120623 0
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 120623 0
Australia
Phone 120623 0
+61 03 9246 8850
Fax 120623 0
Email 120623 0
Michelle.Keske@deakin.edu.au
Contact person for scientific queries
Name 120624 0
A/Prof Michelle Keske
Address 120624 0
Deakin University
221 Burwood Highway
Burwood, VIC 3125
Country 120624 0
Australia
Phone 120624 0
+61 03 9246 8850
Fax 120624 0
Email 120624 0
Michelle.Keske@deakin.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
The results will be published in a journal article. Due to confidentiality we will not be providing individual data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16681Ethical approval    384391-(Uploaded-18-07-2022-14-55-16)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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