Resistance Training in Patients With Diabetic Neuropathy

Sponsor
Danish Pain Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT03252132
Collaborator
Odense University Hospital (Other)
109
1
2
19.6
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 12-week resistance training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
International, randomized controlled training trialInternational, randomized controlled training trial
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Resistance Training in Patients With Diabetic Neuropathy
Actual Study Start Date :
Aug 10, 2017
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Mar 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 12-week resistance training

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.

No Intervention: No training

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danish Pain Research Center, Aarhus University Hospital Aarhus Denmark 8000

Sponsors and Collaborators

  • Danish Pain Research Center
  • Odense University Hospital

Investigators

  • Principal Investigator: Karolina Snopek, MD, Danish Pain Research Center, Aarhus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT03252132
Other Study ID Numbers:
  • IDNC-DD2-MUSCLE
First Posted:
Aug 17, 2017
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021