Diabetes Complications, Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy, Fall Patients, Muscle Weakness, Polyneuropathy Diabetes
Conditions
Brief summary
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2). Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural instability increasing the risk of frequent falls and thereby increased morbidity and mortality. Thus, diabetic neuropathy is associated with significant disabilities having major impact on activities of daily living and quality of life. The effects of resistance training on neuropathy symptoms, muscle strength and muscle structure in patients with and with diabetic neuropathy will be examined.
Detailed description
Perspective: The studies will likely improve the understanding of diabetic neuropathy and the relation between risk of falls in patients with and without motor dysfunction. The results may enable new and more precise recommendations for exercise in diabetic patients with diabetic neuropathy. In addition, the results may lead to a better understanding of the mechanisms underlying the effects of training. The improvement of motor function may lead to improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes patients, resulting in lower morbidity and mortality.
Interventions
OTHER12-week resistance training
Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.
Sponsors
Odense University Hospital
Danish Pain Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
International, randomized controlled training trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of type 2 diabetes
Exclusion criteria
* Neuropathy due to any other cause * BMI \>40 * Pacemaker * Comorbidity that contraindicates exercise * History of stroke with affection of the lower extremities * Ischemic heart disease * Any other neurological disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraepidermal nerve fiber density (IENFD) | Change from baseline IENFD at 12 weeks | 1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function. |
| Muscle strength (isokinetic strength) | Change from baseline IENFD at 12 weeks | Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle. |
Countries
Denmark
Outcome results
None listed