Resistance Training in Patients With Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Polyneuropathy Diabetes; Diabetic Peripheral Neuropathy; Muscle Weakness; Fall Patients; Diabetes Mellitus, Type 2; Diabetes Complications
• Interventions: Other: 12-week resistance training

• Registration Number: NCT03252132
• Lead Sponsor: Danish Pain Research Center

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.

Study Timeline

• Study Start: 2017-08-10
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-17
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-week resistance training	12-week resistance training	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark