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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
4/02/2022
Date data sharing statement initially provided
20/09/2019
Date results information initially provided
11/02/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Physical Activity Intelligence e-Health Program in people with Diabetic neuropathy.
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Scientific title
Feasibility and Efficacy of the Physical Activity Intelligence e-Health Program in Diabetic neuropathy.
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Secondary ID [1]
298176
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none
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Universal Trial Number (UTN)
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Trial acronym
PAIn study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic neuropathy
312744
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musculoskeletal pain
312745
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physical inactivity
314345
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Condition category
Condition code
Metabolic and Endocrine
311243
311243
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0
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Diabetes
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Musculoskeletal
311244
311244
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0
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Other muscular and skeletal disorders
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Neurological
312263
312263
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants 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 and Accredited Exercise Physiologist (AEP) t. 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) patients will be encouraged to self-reflect and discuss strategies to adopt and maintain physical activity targets using the PAI app to monitor adherence. These discussions will be facilitated by a Musculoskeletal Physiotherapist following training by a Clinical Psychologist. 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 asked to report any adverse events to the staff during the intervention or follow-up period.
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Intervention code [1]
314402
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Lifestyle
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Comparator / control treatment
No comparator/control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Proportion of participants that complete the study
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Assessment method [1]
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Timepoint [1]
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12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program
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Primary outcome [2]
319999
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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.
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Assessment method [2]
319999
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Timepoint [2]
319999
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Adverse events will be documented by the Accredited exercise physiologist (AEP) or Physiotherapist at each visit during phase 1. During phase 2, participants will contact research staff if they note adverse events.
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Primary outcome [3]
320000
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Adherence to the PAI program will be evaluated as the number of days during the intervention that the participant achieves 100 PAI points. Week 1 data will be excluded as it takes 7-days to accumulate PAI.
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Assessment method [3]
320000
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Timepoint [3]
320000
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Daily during the intervention, excluding week 1 (it takes 7-days to accumulate PAI).
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Secondary outcome [1]
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Overall physical activity as measured using a wrist-worn tri-axial accelerometer (wGT3X+, ActiGraph, Pensacola, Florida, USA) over a 7 day period
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Assessment method [1]
370145
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Timepoint [1]
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Baseline and 12 weeks post PAI e-Health program
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Secondary outcome [2]
370146
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Diabetic peripheral neuropathy Symptom Impact will be measured using the DPNPI questionnaire (Prod et al 2015), modified to reflect all diabetic neuropathy symptoms.
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Assessment method [2]
370146
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Timepoint [2]
370146
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Baseline and 12 weeks post PAI e-Health program
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Secondary outcome [3]
370147
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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.
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Assessment method [3]
370147
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Timepoint [3]
370147
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Baseline and 12 weeks post PAI e-Health program
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Secondary outcome [4]
370154
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Modified version of Chronic Pain Acceptance Questionnaire (CPAQ) (McCracken et al 2004)
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Assessment method [4]
370154
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Timepoint [4]
370154
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Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program
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Secondary outcome [5]
370159
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Falls efficacy as measured by the Falls Efficacy Scale (FES-I)
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Assessment method [5]
370159
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Timepoint [5]
370159
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Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program
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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.
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Minimum age
30
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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); (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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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 50, 75 and 100 PAI points and adverse events.
To obtain estimates of intervention effects, we will compare physical activity, neuropathy specific quality of life, neuropathy and musculoskeletal symptoms between baseline and 12 weeks using paired t-tests 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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
20/09/2019
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Actual
4/10/2019
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Date of last participant enrolment
Anticipated
1/08/2020
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Actual
5/02/2020
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Date of last data collection
Anticipated
1/12/2020
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Actual
25/05/2020
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Sample size
Target
10
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
26410
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4000 - Brisbane
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Recruitment postcode(s) [2]
26411
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4001 - Brisbane
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Recruitment postcode(s) [3]
26412
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4072 - University Of Queensland
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Recruitment postcode(s) [4]
26413
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4111 - Nathan
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Funding & Sponsors
Funding source category [1]
302711
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University
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Name [1]
302711
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Griffith University New Researcher Grant
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Address [1]
302711
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Griffith University
170 Kessels Road, Nathan, QLD 4111
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Country [1]
302711
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
Griffith University
School of Allied Health Sciences
170 Kessels Road, Nathan, QLD 4111
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Country
Australia
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Secondary sponsor category [1]
302639
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University
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Name [1]
302639
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The University of Queensland
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Address [1]
302639
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The University of Queensland
School of Human Movement and Nutrition Sciences
26b Blair Dr, St Lucia, QLD 4067
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Country [1]
302639
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303321
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Griffith University Human Ethics Committee
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Ethics committee address [1]
303321
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Manager, Research Ethics and Integrity
Office for Research
Griffith University
170 Kessels Road QLD 4111, Australia
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Ethics committee country [1]
303321
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Australia
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Date submitted for ethics approval [1]
303321
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14/02/2019
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Approval date [1]
303321
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07/05/2019
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Ethics approval number [1]
303321
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GU Ref No: 2019/214
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Ethics committee name [2]
303885
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UQ Medical Research Ethics Committee
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Ethics committee address [2]
303885
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University of Queensland St Lucia, QLD 4072
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Ethics committee country [2]
303885
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Australia
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Date submitted for ethics approval [2]
303885
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07/05/2019
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Approval date [2]
303885
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19/06/2019
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Ethics approval number [2]
303885
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2019001070
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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.
The primary aims of this study were to investigate the feasibility, acceptability and safety of the PAI e-health program in people with DPN. The secondary aims were to explore the clinical impact of the PAI e-Health program on physical activity, sleep and symptoms including the intensity of DPN symptoms and quality of life. It was hypothesised that participants who attended the program would be satisfied with the e-health program and PAI technology, be able to achieve health-enhancing levels of physical activity and not experience major adverse events.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Brooke Coombes
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Address
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School of Allied Health Sciences
Griffith University
170 Kessels Road, Nathan, QLD 4111
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Country
93266
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Australia
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Phone
93266
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+61 7 5552 7087
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Fax
93266
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Email
93266
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[email protected]
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Contact person for public queries
Name
93267
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Dr Brooke Coombes
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Address
93267
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School of Allied Health Sciences
Griffith University
170 Kessels Road, Nathan, QLD 4111
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Country
93267
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Australia
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Phone
93267
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+61 7 5552 7087
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Fax
93267
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Email
93267
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[email protected]
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Contact person for scientific queries
Name
93268
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Dr Brooke Coombes
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Address
93268
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School of Allied Health Sciences
Griffith University
170 Kessels Road, Nathan, QLD 4111
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Country
93268
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Australia
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Phone
93268
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+61 7 5552 7087
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Fax
93268
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Email
93268
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This is a pilot study. Data sharing will be made available following completion of a fully powered trial.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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