None listed
Conditions
Brief summary
Australian data, including ours from NSW, show that in people with diabetes weekly exercise volumes are below the Australian adult general population. In addition, when a person develops a DFU they are commonly instructed by clinicians to avoid any non-essential weight-bearing physical activity. Yet, exercise has significant benefit for people with diabetes including improved aerobic fitness and glycaemic control, reductions in all-cause mortality and possibly improved healing of ulcers. People with DFU require specialist exercise therapy to reduce plantar pressures and manage concomitant diseases. Upper limb seated cycle ergometry (UCE) involving thrice weekly sessions can improve cardiovascular fitness and does not increase plantar pressures. In addition, UCE can be complemented by resistance exercise in the upper body and open chain lower-body exercises to provide further metabolic benefit. Combined UCE and resistance exercise may be a safe and effective method for improving glycaemic control and aerobic fitness in people with DFUs. AEPs have appropriate clinical skills, in collaboration with other High Risk Foot Services (iHRFS) disciplines, to safely pre-screen and implement exercise for adults with DFUs. HYPOTHESIS Participants undertaking regular exercise will improve cardiorespiratory fitness (VO2peak), muscular strength (1RM strength) and glycaemic control (HbA1c, fasting plasma glucose). Exercise may also affect biomarkers of healing outcomes and immunophenotype. Study participants are expected to find that the exercise is a positive experience with high acceptability, which may be found to improve quality of life scores.
Interventions
Supervised Exercise Intervention: Those participants randomised to the exercise arm will undertake 12 weeks of upper limb cycle ergometry (UCE) and resistance training for supervised three times weekly exercise in small groups. An Accredited Exercise Physiologist (AEP) will undertake all exercise testing and supervision. Initially, UCE will commence at 60% VO2peak and progress to 70-80% over 2 weeks or as tolerated. UCE exercise duration will progress from 15 to 30 mins three times each week. F
Supervised Exercise Intervention: Those participants randomised to the exercise arm will undertake 12 weeks of upper limb cycle ergometry (UCE) and resistance training for supervised three times weekly exercise in small groups. An Accredited Exercise Physiologist (AEP) will undertake all exercise testing and supervision. Initially, UCE will commence at 60% VO2peak and progress to 70-80% over 2 weeks or as tolerated. UCE exercise duration will progress from 15 to 30 mins three times each week. Following UCE, resistance exercise of approximately 30 mins will be carried out in the same session. Resistance exercise will commence at 60% of 1 repetition maximum (1RM) for 2 sets of 8-12 repetitions and progress to 80% of 1RM by week 2 or as tolerated. Upper limb exercises include chest press, lat pulldown, seated row and tricep pushdown. Lower limb open chain exercises include knee extension, hamstring curl and hip extension. After 12 weeks, follow-up measures will be undertaken as per baseline data-collection. Supervised exercise sessions will be carried out at the Charles Perkins Royal Prince Alfred (CPC RPA) Clinic located next to Royal Prince Alfred Hospital (RPAH).
Sponsors
University of Sydney
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 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18-70 years of age. 2. Have confirmed diabetes mellitus (HbA1c equal to or greater than6.5%). 3. Foot ulcer of greater than 4 weeks duration. 4. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. Pregnancy or breastfeeding. 2. Underlying osteomyelitis. 3. Severe peripheral artery disease (Arterial Brachial Index equal to or greater than 0.7). 4. Severe infection (WIFI Criteria). 5. Uncontrolled psychiatric illness. 6. Recent onset cardiovascular disease (coronary artery disease, myocardial infarction, etc, within 6 months). 7. Musculoskeletal pathology that would impede capacity to carry out the exercise assessments and intervention. 8. Participants who are not fluent in English or who have difficulty understanding English
Outcome results
None listed