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Improving Mobility in Diabetic Patients Through Resistance Training

Primary Purpose

Diabetic Patients With Polyneuropathy

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
resistance training
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Patients With Polyneuropathy focused on measuring Muscle strength, Physical activity, Mobility, Gait analysis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diabetic patients with polyneuropathy:
  • valkscore >5;
  • diabetic type 2;
  • age >50 years

Exclusion Criteria:

  • muscular related diseases;
  • ischemia;
  • amputation (except for toe amputation)

Sites / Locations

  • Academic Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

resistance training

control

Arm Description

During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.

No intervention was prescribed

Outcomes

Primary Outcome Measures

Mobility

Secondary Outcome Measures

Full Information

First Posted
September 24, 2008
Last Updated
October 6, 2015
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00759265
Brief Title
Improving Mobility in Diabetic Patients Through Resistance Training
Official Title
Improving Mobility in Diabetic Patients Through Resistance Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life. The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Patients With Polyneuropathy
Keywords
Muscle strength, Physical activity, Mobility, Gait analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
resistance training
Arm Type
Experimental
Arm Description
During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention was prescribed
Intervention Type
Other
Intervention Name(s)
resistance training
Intervention Description
During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.
Primary Outcome Measure Information:
Title
Mobility
Time Frame
0 month, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diabetic patients with polyneuropathy: valkscore >5; diabetic type 2; age >50 years Exclusion Criteria: muscular related diseases; ischemia; amputation (except for toe amputation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teunis H IJzerman, MSc
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24138784
Citation
Melai T, Schaper NC, Ijzerman TH, de Lange TL, Willems PJ, Lima Passos V, Lieverse AG, Meijer K, Savelberg HH. Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial. J Foot Ankle Res. 2013 Oct 18;6(1):41. doi: 10.1186/1757-1146-6-41.
Results Reference
derived

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Improving Mobility in Diabetic Patients Through Resistance Training

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