Resistance Training in Patients With Diabetic Neuropathy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Resistance Training in Patients With Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252132
• Other study ID #: IDNC-DD2-MUSCLE
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2021
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Fall Patients
• Muscle Weakness
• Peripheral Nervous System Diseases
• Polyneuropathies
• Polyneuropathy Diabetes

Intervention

Other:
• 12-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.

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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