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Resistance Training in Patients With Diabetic Neuropathy

Primary Purpose

Diabetes Mellitus, Type 2, Polyneuropathy Diabetes, Diabetes Complications

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
12-week resistance training
Sponsored by
Danish Pain Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Danish Pain Research Center, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

12-week resistance training

No training

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2017
Last Updated
August 17, 2021
Sponsor
Danish Pain Research Center
Collaborators
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03252132
Brief Title
Resistance Training in Patients With Diabetic Neuropathy
Official Title
Resistance Training in Patients With Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Pain Research Center
Collaborators
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Polyneuropathy Diabetes, Diabetes Complications, Diabetic Peripheral Neuropathy, Muscle Weakness, Fall Patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
International, randomized controlled training trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12-week resistance training
Arm Type
Active Comparator
Arm Title
No training
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
12-week resistance training
Intervention Description
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 Outcome Measure Information:
Title
Intraepidermal nerve fiber density (IENFD)
Description
1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.
Time Frame
Change from baseline IENFD at 12 weeks
Title
Muscle strength (isokinetic strength)
Description
Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.
Time Frame
Change from baseline IENFD at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karolina Snopek, MD
Organizational Affiliation
Danish Pain Research Center, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35048156
Citation
Khan KS, Overgaard K, Tankisi H, Karlsson P, Devantier L, Gregersen S, Jensen TS, Finnerup NB, Pop-Busui R, Dalgas U, Andersen H. Effects of progressive resistance training in individuals with type 2 diabetic polyneuropathy: a randomised assessor-blinded controlled trial. Diabetologia. 2022 Apr;65(4):620-631. doi: 10.1007/s00125-021-05646-6. Epub 2022 Jan 19.
Results Reference
derived

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Resistance Training in Patients With Diabetic Neuropathy

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