Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR


Registration number
ACTRN12619001300167
Ethics application status
Approved
Date submitted
21/07/2019
Date registered
20/09/2019
Date last updated
21/10/2019
Date data sharing statement initially provided
20/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical Activity Intelligence e-Health Program in people with Diabetic neuropathy.
Scientific title
Feasibility and Efficacy of the Physical Activity Intelligence e-Health Program in Diabetic neuropathy.
Secondary ID [1] 298176 0
none
Universal Trial Number (UTN)
Trial acronym
PAIn study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic neuropathy 312744 0
musculoskeletal pain 312745 0
physical inactivity 314345 0
Condition category
Condition code
Metabolic and Endocrine 311243 311243 0 0
Diabetes
Musculoskeletal 311244 311244 0 0
Other muscular and skeletal disorders
Neurological 312263 312263 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PAI GROUP
Participants randomised to the PAI Group will be required to attend 4 x 2 hr education and exercise sessions (weeks 1-4) at Griffith University (Mt Gravatt or Nathan campuses) or University of Queensland (St Lucia campus). The sessions will be group based (4-6 participants). Over the four weeks, participants will interact with a Musculoskeletal Physiotherapist, Accredited Exercise Physiologist (AEP) and Clinical Psychologist. At the first session participants will be given a fitness wristband (to keep) that measures heart rate when exercising to calculate a weekly Physical Activity Intelligence (PAI) score. PAI is an innovative, scientifically valid and easily understood metric that informs individuals about the quantity and intensity of physical activity needed to obtain or sustain good health.

Each session will consist of PAI-learning, PAI-playtime and PAI-behaviour change. During PAI-learning (~30mins of demonstrations, group activities, led by AEP or physiotherapist) participants will learn how to use the PAI app on their smartphone, how to activate heart rate recording and how to troubleshoot problems. During PAI-playtime (~ 1hr), an AEP or Physiotherapist will guide participants through short bouts (of 5-10minutes) of different types and intensities of exercise (including flat walking, hill/stair walking, high intensity intervals, body weight resisted exercise (squats, pushups, calf raises) to see the different ways PAI can be obtained. During PAI-behaviour change (~ 30mins, self-reflection, counselling, discussion) a clinical psychologist will assist patients to adopt and maintain physical activity targets using the PAI app to monitor adherence. Participants will be advised to gradually increase their activity over the first four weeks to achieve a PAI score of at least 100 points/week by four weeks.
By the end of the 4 weeks, participants shall be able to use the PAI App, connect App to the wristband, sync data, and know where to get help if they experience any App-problems throughout the study period, know how to mix and match exercises of varying modality and intensity to reach 100 PAI points/week. Participants will be asked to engage in activities to keep their PAI score above 100 points for as many days as possible during weeks 5-12 of the intervention period. Participants will be given a paper based diary to record any adverse events or reasons they were unable to obtain 100 PAI points/week. Every two weeks a research assistant will telephone the participant to obtain this information.
Intervention code [1] 314402 0
Lifestyle
Comparator / control treatment
CONTROL GROUP
Participants randomised to the Control Group will continue to receive usual care from their GP and/or other health care providers. In accordance with the current guidelines on exercise for people with Type 2 Diabetes by Exercise and Sport Science Australia (ESSA), they will receive a written pamphlet explaining the role of exercise in diabetes management, including physical activity recommendations. This pamphlet is based on the following readily available resource: https://www.essa.org.au/wp-content/uploads/2015/10/ESSA_Diabetes-Position-Statement.pdf
Control group
Active

Outcomes
Primary outcome [1] 319998 0
Proportion of participants that complete the study
Timepoint [1] 319998 0
12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Primary outcome [2] 319999 0
Adverse events including extreme breathlessness, chest pain, musculoskeletal events, hypoglycaemia, falls, acute illnesses, changes in health status or medications, will be recorded by a paper based diary.
Timepoint [2] 319999 0
Every two weeks (for 12 weeks post randomisation) a research assistant will telephone the participant to obtain this information.
Primary outcome [3] 320000 0
Adherence to the PAI program will be evaluated as the number of days during weeks 5-12 of the intervention that the participant achieves 100 PAI points.
Timepoint [3] 320000 0
Weekly during weeks 5-12 weeks post commencement of PAI e-Health program
Secondary outcome [1] 370145 0
Overall physical activity as measured using a wrist-worn tri-axial accelerometer (wGT3X+, ActiGraph, Pensacola, Florida, USA) over a 7 day period
Timepoint [1] 370145 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Secondary outcome [2] 370146 0
Diabetic peripheral neuropathy Symptom Impact will be measured using the DPNPI questionnaire (Prod et al 2015), modified to reflect all diabetic neuropathy symptoms.
Timepoint [2] 370146 0
Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program
Secondary outcome [3] 370147 0
Composite outcome: The intensity of "in the moment" symptoms of foot neuropathy or musculoskeletal trouble as measured by mobile app survey delivered 6 times per day over a 7 day period.
Timepoint [3] 370147 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Secondary outcome [4] 370149 0
Functional mobility will be assessed by Timed Up and Go (TUAG) test
Timepoint [4] 370149 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Secondary outcome [5] 370152 0
Glucose control will be evaluated by HbA1c and fasting blood glucose
Timepoint [5] 370152 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Secondary outcome [6] 370154 0
Modified version of Chronic Pain Acceptance Questionnaire (CPAQ) (McCracken et al 2004)
Timepoint [6] 370154 0
Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program
Secondary outcome [7] 370159 0
Falls efficacy as measured by the Falls Efficacy Scale (FES-I)
Timepoint [7] 370159 0
Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program
Secondary outcome [8] 373305 0
Lower limb physical function will be measured by 5 times sit to stand test (5XSTS)
Timepoint [8] 373305 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Secondary outcome [9] 374869 0
A composite outcome of single leg balance with eyes open (and eyes closed) will be assessed using a stopwatch and recorded in seconds until loss of balance (or opening of eyes) or a maximum of 30s is reached.
Timepoint [9] 374869 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
Secondary outcome [10] 374870 0
Time to ascend a flight of stairs (10 steps) will be assessed using a stopwatch and recorded in seconds.
Timepoint [10] 374870 0
Baseline, 12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program

Eligibility
Key inclusion criteria
Community dwelling adults aged 30-70 years, ambulant without aids, with a medical diagnosis of type 2 diabetes and DSPN. Participants will be screened for diabetic neuropathy using ankle-reflex, monofilament and vibration tests, with positive results identified by absence of bilateral Achilles tendon reflex, 10g monofilament sensation or 128-Hz tuning fork vibration perception threshold of lower than four. Nerve conduction tests will be performed to evaluate lower limb peripheral nerve function if feasible (researcher availability and participant consent). Participants must have a smart phone and be willing/able to complete testing, training and surveys.
Minimum age
30 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded for known diagnoses of (1) Cardiorespiratory disease (including but not limited to myocardial infarction within preceding 6 months, unstable angina, coronary artery disease, severe hypertension (systolic BP>200 mm Hg and/or diastolic BP>110 mm Hg), uncontrolled cardiac arrhythmias, severe haemodynamically significant valvular disease, heart failure, acute pulmonary embolus, pulmonary infarction or deep venous thrombosis, acute myocarditis or pericarditis, aneurysm or using ß-blockers); (2) cancer (currently receiving treatment for active cancer); (3) neurological disorder (e.g. stroke, spinal cord injury or traumatic brain injury); (4) psychiatric history (currently in care of a mental health care provider or taking multiple psychiatric medications; (5) chronic pain syndrome or neuropathy due to non- diabetic causes (e.g. fibromyalgia, irritable bowel syndrome, alcoholic neuropathy, chemotherapy induced neuropathy, peripheral arterial disease (absence of peripheral pulses) or kidney disease (stage 3 or greater)); (6) current foot/leg ulcer (currently receiving treatment for active ulcer); (7) significant cognitive impairment, alcohol abuse or any other condition preventing an ability to perform physical activity; (8) participating in another clinical intervention or exercise study or (9) meeting Exercise and Sport Science Australia physical activity guidelines (210 minutes of moderate or 125 minutes of vigorous aerobic exercise per week).

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 will be by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule using block sizes of 10 will be generated by a researcher not involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse the proportion of participants completing the study; adherence to the PAI face:to:face sessions; adherence to 100 PAI points and adverse events.

To obtain estimates of intervention effects, we will compare changes in physical activity, neuropathy specific quality of life, neuropathy and musculoskeletal symptoms, physical function and glucose control between PAI e-Health and control groups using analysis of variance, adjusted for baseline score. We will conduct an independent ANOVA for each outcome measure. Alpha will be set at 0.05, and power at 80% for all statistical analysis. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. This will decrease the chance of Type II error, increasing the chance of identifying potentially important differences between groups. This statistical approach is considered appropriate for feasibility or exploratory studies.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26410 0
4000 - Brisbane
Recruitment postcode(s) [2] 26411 0
4001 - Brisbane
Recruitment postcode(s) [3] 26412 0
4072 - University Of Queensland
Recruitment postcode(s) [4] 26413 0
4111 - Nathan

Funding & Sponsors
Funding source category [1] 302711 0
University
Name [1] 302711 0
Griffith University New Researcher Grant
Address [1] 302711 0
Griffith University
170 Kessels Road, Nathan, QLD 4111
Country [1] 302711 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
School of Allied Health Sciences
170 Kessels Road, Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 302639 0
University
Name [1] 302639 0
The University of Queensland
Address [1] 302639 0
The University of Queensland
School of Human Movement and Nutrition Sciences
26b Blair Dr, St Lucia, QLD 4067
Country [1] 302639 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303321 0
Griffith University Human Ethics Committee
Ethics committee address [1] 303321 0
Manager, Research Ethics and Integrity
Office for Research
Griffith University
170 Kessels Road QLD 4111, Australia
Ethics committee country [1] 303321 0
Australia
Date submitted for ethics approval [1] 303321 0
14/02/2019
Approval date [1] 303321 0
07/05/2019
Ethics approval number [1] 303321 0
GU Ref No: 2019/214
Ethics committee name [2] 303885 0
UQ Medical Research Ethics Committee
Ethics committee address [2] 303885 0
University of Queensland St Lucia, QLD 4072
Ethics committee country [2] 303885 0
Australia
Date submitted for ethics approval [2] 303885 0
07/05/2019
Approval date [2] 303885 0
19/06/2019
Ethics approval number [2] 303885 0
2019001070

Summary
Brief summary
The aims of this pilot study are to investigate the feasibility and efficacy of an eHealth program in 20 participants with diabetes with clinically symptomatic diabetic sensory polyneuropathy (DSPN). The e-Health program uses a smartphone app that collects data from a wrist-worn heart rate monitoring device and calculates a weekly Physical Activity Intelligence (PAI) score. PAI is an innovative, scientifically valid and easily understood metric that informs individuals about the quantity and intensity of physical activity needed to obtain or sustain good health.

We hypothesise (1) at least 70% of enrolled participants will complete the study; (2) at least 70% of participants allocated to PAI eHealth program will meet the physical activity target (100 PAI points/week) for 6 out of 8 weeks (during weeks 5-12 of the intervention).
As this is a pilot study, estimates of the effect of the PAI eHealth program compared to a control intervention (usual advice for physical activity) will inform sample size calculations for a fully powered RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93266 0
Dr Brooke Coombes
Address 93266 0
School of Allied Health Sciences
Griffith University
170 Kessels Road, Nathan, QLD 4111
Country 93266 0
Australia
Phone 93266 0
+61 7 5552 7087
Fax 93266 0
Email 93266 0
b.coombes@griffith.edu.au
Contact person for public queries
Name 93267 0
Dr Brooke Coombes
Address 93267 0
School of Allied Health Sciences
Griffith University
170 Kessels Road, Nathan, QLD 4111
Country 93267 0
Australia
Phone 93267 0
+61 7 5552 7087
Fax 93267 0
Email 93267 0
b.coombes@griffith.edu.au
Contact person for scientific queries
Name 93268 0
Dr Brooke Coombes
Address 93268 0
School of Allied Health Sciences
Griffith University
170 Kessels Road, Nathan, QLD 4111
Country 93268 0
Australia
Phone 93268 0
+61 7 5552 7087
Fax 93268 0
Email 93268 0
b.coombes@griffith.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
This is a pilot study. Data sharing will be made available following completion of a fully powered trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results