None listed
Conditions
Brief summary
Diabetic neuropathy is a common co-morbidity of diabetes that is a risk factor for foot ulceration and lower limb amputation. Exercise interventions may have the potential to reduce the burden of diabetic foot problems as a recent study demonstrated improvement in peripheral neuropathy symptoms after a structured exercise program in laboratory conditions. Exploration of these promising results in a pragmatic environment is required to understand the true effect of exercise in the management of peripheral neuropathy. Therefore, we will attempt to answer the following research question: Does structured exercise training improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy? To answer this question, a pilot randomised controlled trial will be conducted. People with diabetes and peripheral neuropathy will be recruited. Following preliminary testing and randomisation, participants will attend three supervised exercise sessions per week or a diabetes lifestyle coaching program for 8-weeks. Repeat testing will be completed after the completion of the exercise or education program. The primary outcome will be the validated Michigan Neuropathy Screening Instrument score and secondary outcomes will include three separate physical function tests that explore aerobic fitness, lower limb endurance and balance. Based on neuropathy-related effect found in the previous study, approximately 24 participants in each group are required to identify a medium effect (power = 80%, p = 0.05).
Interventions
Exercise
The 8- week exercise program will be performed three times per week and has both aerobic and strengthening components and is based on American Diabetes Association and American College of Sports Medicine recommendations and informed by guidelines for the Medicare funded Type 2 Diabetes Allied Health Group Program.
The program will be individually prescribed and undertaken in a group environment of no more than eight participants. All exercise sessions will be preceded by warm-up and s
Exercise The 8- week exercise program will be performed three times per week and has both aerobic and strengthening components and is based on American Diabetes Association and American College of Sports Medicine recommendations and informed by guidelines for the Medicare funded Type 2 Diabetes Allied Health Group Program. The program will be individually prescribed and undertaken in a group environment of no more than eight participants. All exercise sessions will be preceded by warm-up and stretching. The aerobic component will progress from 10 min at 50% heart rate reserve to 50 min at 70% heart rate reserve. The strengthening component will begin at 2 sets of 10 repetitions for each exercise gradually progressing to 3 sets of 15 repetitions to maintain rating of perceived exertion in a moderate range (7–8 out of 10). The exercise intervention will be supervised by an Accredited Exercise Physiologist and the program of exercise will be approved by the participant’s General Practitioner.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than 18 years Clinical diagnosis of Type 1 or Type 2 diabetes confirmed by General Practitioner Michigan Neuropathy Screening Instrument score of >2 (examination component) and; Approval from General Practitioner to participate
Exclusion criteria
An inability to understand instructions Serious cardiac pathology Musculoskeletal problems that would seriously limit exercise Open wounds on the weight-bearing surface of the feet Inability to ambulate independently Stroke or central nervous system pathology Stage 2 hypertension (resting blood pressure: systolic >160 mmHg or diastolic >100 mmHg).
Outcome results
None listed