None listed
Conditions
Brief summary
The beneficial effects of physical activity and exercise on pain, function and quality of life in people with chronic musculoskeletal pain are well-described. In rodents, exercise can reduce neuropathic pain and improve nerve function and structure, but whether physical activity and exercise improve these same outcomes in people with neuropathic pain is poorly understood. Improving understanding of the relationship between physical activity with pain and nerve structure/function in people with diabetic peripheral neuropathy, as well as the effect of a single bout of exercise on these outcomes, could help improve exercise programming to prevent or slow progression of diabetic neuropathy. We hypothesise that an acute bout of exercise will briefly reduce pain in people with diabetic neuropathy. We also hypothesise that people with diabetic neuropathy who are more physically active will report less pain and have less impaired nerve structure and function.
Interventions
The intervention will involve a single bout of aerobic exercise on a stationary cycle ergometer (Monark 928 G3). The intervention will be delivered face-to-face on an individual basis by an undergraduate Exercise Physiology student under the supervision of an Accredited Exercise Physiologist. The exercise bout will commence with a 5-minute warmup at low intensity (approximately 40% of the participant's age-predicted maximum heart rate), followed by 15 minutes of moderate intensity exercise (60-7
The intervention will involve a single bout of aerobic exercise on a stationary cycle ergometer (Monark 928 G3). The intervention will be delivered face-to-face on an individual basis by an undergraduate Exercise Physiology student under the supervision of an Accredited Exercise Physiologist. The exercise bout will commence with a 5-minute warmup at low intensity (approximately 40% of the participant's age-predicted maximum heart rate), followed by 15 minutes of moderate intensity exercise (60-70% of participant's age-predicted maximum heart rate). After the warm up, participants will be encouraged to exercise at 70% of their age-predicted maximum heart rate for the remaining duration of the exercise bout, but will be allowed to exercise at intensities as low as 60% of their age-predicted maximum heart rate if needed. On this basis, the intervention will be tailored to each individual. At the end of the warm up, and then every 5 minutes during exercise, the participant's heart rate, blood pressure and rating of perceived exertion (Borg 6-20 scale) will be recorded. The exercise bout will end with a 2-3 minute cool down at low intensity (rating of perceived exertion 8-9/20). The entire experimental session will last up to 120 minutes depending on whether or not it is performed first in the crossover design. If performed first, the rest of the experimental session will consist of assessments of pressure pain threshold before and after exercise (15 min), monitoring of the participant for any adverse signs/symptoms following exercise (up to 60 min), completion of questionnaires relating to the participants' health and level of physical activity (20 min), and provision of an accelerometer (Actigraph wGT3X-WT) (5 min) which will be used to measure the participant's physical activity levels for one week following the first session. If performed second, the experimental session will last up to 90 minutes as the questionnaires and accelerometer procedures will not be performed. All testing will be performed in the Exercise Physiology laboratories at UNSW Sydney
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be males and females aged 18-65 with a diagnosis of Type 2 diabetes mellitus and evidence of neuropathy according to the Total Neuropathy Score (Grades 0-4). Participants must also be able to speak, read and write in English.
Exclusion criteria
1. Unable to speak, read or write in English or provide informed consent 2. History of hypoglycaemia unawareness 3. Uncontrolled diabetes or hospitilisation from ketoacidosis or hypoglycaemia in the month prior to testing 4. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. 4. Have received neuromodulatory medication within the last month. 5. Have received/currently receiving an investigatory drug within the last 3 months. 6. Symptoms or signs that are contraindications to exercise and have not been cleared by their physician for exercise will be excluded from randomisation to exercising groups. However, these individuals will still invited to complete questionnaires and undergo 7 days of accelerometer-based physical activity monitoring
Outcome results
None listed