Improving Mobility in Diabetic Patients Through Resistance Training

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00759265
First received: September 24, 2008
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Diabetic Patients With Polyneuropathy
Other: resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Mobility in Diabetic Patients Through Resistance Training

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Mobility [ Time Frame: 0 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2006
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resistance training

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.

Other: resistance training

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.


  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759265

Locations
Netherlands
Academic Hospital Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Teunis H IJzerman, MSc Maastricht UMC
  More Information

No publications provided

Responsible Party: Savelberg PhD, University Maastricht
ClinicalTrials.gov Identifier: NCT00759265     History of Changes
Other Study ID Numbers: 06-3-031
Study First Received: September 24, 2008
Last Updated: July 22, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Muscle strength
Physical activity
Mobility
Gait analysis

Additional relevant MeSH terms:
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014