Physical Activity Intelligence e-Health Program in people with Diabetic neuropathy.
- Conditions
- Diabetic neuropathymusculoskeletal painMetabolic and Endocrine - DiabetesNeurological - Other neurological disordersphysical inactivityMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12619001300167
- Lead Sponsor
- Griffith University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants that complete the study[12 weeks post randomisation (control) or 12 weeks post commencement of PAI e-Health program];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. [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. ];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. [Daily during the intervention, excluding week 1 (it takes 7-days to accumulate PAI). ]
- Secondary Outcome Measures
Name Time Method Overall physical activity as measured using a wrist-worn tri-axial accelerometer (wGT3X+, ActiGraph, Pensacola, Florida, USA) over a 7 day period[Baseline and 12 weeks post PAI e-Health program];Diabetic peripheral neuropathy Symptom Impact will be measured using the DPNPI questionnaire (Prod et al 2015), modified to reflect all diabetic neuropathy symptoms.<br>[Baseline and 12 weeks post PAI e-Health program];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.[Baseline and 12 weeks post PAI e-Health program];Modified version of Chronic Pain Acceptance Questionnaire (CPAQ) (McCracken et al 2004)[Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program];Falls efficacy as measured by the Falls Efficacy Scale (FES-I)[Baseline, 12 weeks & 12 months post randomisation (control) or post commencement of PAI e-Health program]