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Completed

NCT Number: NCT03252132

Resistance Training in Patients With Diabetic Neuropathy

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Peripheral Neuropathy Endocrine System Diseases Fall Patients Glucose Metabolism Disorders Metabolic Diseases Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathy Diabetes Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-week resistance training

Other

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.

Primary outcomes

  1. Intraepidermal nerve fiber density (IENFD)

    Time frame: 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.

  2. Muscle strength (isokinetic strength)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Odense University Hospital

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2017
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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