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

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115205
• Other study ID #: CE 1264
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: May 3, 2010
• Start date: March 2006
• Est. completion date: January 2009

Study information

• Verified date: May 2010
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Supervised walking
Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
• Standard counselling procedure
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in haemoglobin A1c (HbA1c) levels	The measurement of HbA1c is carried out with a DCCT-aligned method.	4 months	No
Secondary	Change in Body weight		4 months	No
Secondary	Change in Fasting plasma glucose levels		4 months	No
Secondary	Change in Total Cholesterol levels		4 months	No
Secondary	Change in HDL Cholesterol levels		4 months	No
Secondary	Change in LDL Cholesterol levels		4 months	No
Secondary	Change in Triglycerides levels		4 months	No
Secondary	Change in Blood Pressure		4 months	No
Secondary	Change in 6 minutes walk distance	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.	4 months	No
Secondary	Change in C-reactive protein levels		4 months	No
Secondary	Change in Energy expenditure through voluntary physical activity	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.	4 months	No
Secondary	Change in Antidiabetic medications	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.	4 months	No
Secondary	Compliance with walking sessions	Attendance at the scheduled walking sessions is recorded for each patient.	4 months	No