Skip to main content
OpenTrials
Completed

NCT Number: NCT01115205

Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes

The purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.

Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes known for at least 2 yr
  • physical inactivity
  • haemoglobin (Hb)A1c between 6.5-9.9%
  • treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
  • willingness to participate in a programme of regular physical activity

Exclusion criteria

  • moderate-severe autonomic or somatic neuropathy
  • severe lower limb vasculopathy
  • pre-proliferative or proliferative active retinopathy
  • moderate to severe chronic renal failure
  • unstable angina or recent (in the previous 3 months) myocardial infarction
  • acute intercurrent diseases
  • acute metabolic decompensation (blood glucose >300 mg/dl or ketonuria in two consecutive checks)
  • use of beta-blocker drugs
  • subjects unable to complete a 6-min walk test

Treatment and study plan

Supervised walking

Behavioral

Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.

Standard counselling procedure

Behavioral

Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity. In addition, one group session of counselling on these issues.

Primary outcomes

  1. Change in haemoglobin A1c (HbA1c) levels

    Time frame: 4 months

    The measurement of HbA1c is carried out with a DCCT-aligned method.

Secondary outcomes

  1. Change in Body weight

    Time frame: 4 months

  2. Change in Fasting plasma glucose levels

    Time frame: 4 months

  3. Change in Total Cholesterol levels

    Time frame: 4 months

  4. Change in HDL Cholesterol levels

    Time frame: 4 months

  5. Change in LDL Cholesterol levels

    Time frame: 4 months

  6. Change in Triglycerides levels

    Time frame: 4 months

  7. Change in Blood Pressure

    Time frame: 4 months

  8. Change in 6 minutes walk distance

    Time frame: 4 months

    This test measures the number of meters that can be walked in 6 minutes over a 30 m course. It is a simple field test to assess aerobic functional capacity.

  9. Change in C-reactive protein levels

    Time frame: 4 months

  10. Change in Energy expenditure through voluntary physical activity

    Time frame: 4 months

    Energy expenditure is estimated through 7-day activity diaries. The intensity of each activity (defined in metabolic equivalents, MET) is multiplied by duration and the product for each activity is summed to give a total activity score in MET hours/week.

  11. Change in Antidiabetic medications

    Time frame: 4 months

    Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol, to assess changes in hypoglycemic medication during the trial.

  12. Compliance with walking sessions

    Time frame: 4 months

    Attendance at the scheduled walking sessions is recorded for each patient.

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Assessment of Feasibility and Efficacy of a Project Aimed to Improve Metabolic Control in Type 2 Diabetes Through Lifestyle Changes and Self-monitoring of Blood Glucose

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
May 4, 2010
Registry last updated
May 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.