Improving Mobility in Diabetic Patients Through Resistance Training

Not Applicable

Completed

• Conditions: Diabetic Patients With Polyneuropathy
• Interventions: Other: resistance training

• Registration Number: NCT00759265
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2010-02
• Status Verified: 2010-07
• Study Completion: 2011-01
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistance training	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.

Primary Outcome Measures

Name	Time	Method
Mobility	0 month, 3 months, 6 months, 12 months

Trial Locations

Locations (1)

Academic Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands