None listed
Conditions
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.
Interventions
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
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.
Sponsors
Griffith University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed