Resistance Training in Patients With Diabetic Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resistance Training in Patients With Diabetic Neuropathy

Conditions
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Diabetes Mellitus, Type 2, Polyneuropathy Diabetes, Diabetes Complications, Diabetic Peripheral Neuropathy, Muscle Weakness, Fall Patients

Intervention / Treatment
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* Other: 12-week resistance training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: International, randomized controlled training trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 12-week resistance training<br> | Other: 12-week resistance training<br>* 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.<br>|
| No Intervention: No training<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraepidermal nerve fiber density (IENFD) | 1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function. | Change from baseline IENFD at 12 weeks | 
| Muscle strength (isokinetic strength) | Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle. | Change from baseline IENFD at 12 weeks |