Improving Mobility in Diabetic Patients Through Resistance Training

Diabetic Patients With Polyneuropathy Clinical Trial

Official title:

Improving Mobility in Diabetic Patients Through Resistance Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759265
• Other study ID #: 06-3-031
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: October 6, 2015
• Start date: May 2006
• Est. completion date: January 2011

Study information

• Verified date: July 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Patients With Polyneuropathy
• Polyneuropathies

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Academic Hospital Maastricht	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility		0 month, 3 months, 6 months, 12 months	Yes