Validation study to assess limitations in mobility among patients with type 2 diabetes.

Completed

• Conditions: 10012653; insulin-independent diabetes mellitus; type 2 diabetes

• Registration Number: NL-OMON31102
• Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

Type 2 diabetes mellitus, age > 40 years and able to walk at least 6 minutes unassisted

Exclusion Criteria

limited mobility due to severe joint problems, any amputation exceeding toe amputation(s), foot ulcus < 1 year ago, severe peripheral arterial disease (claudication with walking distance less than 1000 meter and/or Doppler ankle brachial index less than 0.7), myopathies, CVA with motor impairment, cancer, severe exercise capacity limitations (NYHA classification > 2) due to cardiac or pulmonary disfunction (decompensatio cordis, angina pectoris, recent myocardial infarction (< 6 months)), pregnancy, high intake of alcohol and drugs, weight change more than 4 kg in the last 4 weeks, severe rheumatoid arthritis, knee- or ankleprosthesis, vision < 0.5 with correction

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Correlation between the 6 minutes walk and the time to get up and go, balance<br /><br>tests and walking an 8 stairway up and down. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Prevalence of limitations in mobility, measured with the 6 minutes walk, and<br /><br>the difference in prevalence between patients without polyneuropathy and<br /><br>peripheral arterial disease, patients with polyneuropathy and patients with<br /><br>both polyneuropathy and peripheral arterial disease. </p><br>