Exercise Training Intervention in Children With Type 1 Diabetes

NCT ID: NCT01220479

Last Updated: 2010-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2009-06-30

Brief Summary

Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these conditions lays in childhood. Exercise is known to have a positive influence on bone mineral density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but little is known about these associations in children with T1DM.

The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise training program on skeletal development in children with T1DM, compared to healthy subjects. The second aim is to evaluate whether the program influences also cardiovascular diseases risk factors.

This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy children. Both groups are randomly divided (1:1) in an exercise or a control group: 1) exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.

Exercise groups participate to an identical weight-bearing exercise training program 2 x 90 minutes per week and controls are relatively inactive.

Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Healthy

Group Type: NO_INTERVENTION

Exercise training program

Intervention Type: BEHAVIORAL

Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.

Control groups are relatively inactive.

Control Diabetic

Group Type: NO_INTERVENTION

Exercise training program

Intervention Type: BEHAVIORAL

Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.

Control groups are relatively inactive.

Exercise Diabetic

Group Type: EXPERIMENTAL

Exercise training program

Intervention Type: BEHAVIORAL

Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.

Control groups are relatively inactive.

Exercise Healthy

Group Type: EXPERIMENTAL

Exercise training program

Intervention Type: BEHAVIORAL

Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.

Control groups are relatively inactive.

Interventions

Exercise training program

Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.

Control groups are relatively inactive.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1) disease for at least 1 year.

1) good general health and normal growth.

Exclusion Criteria

1. presence of other chronic disease, including thyroid disease;

2. medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months;

3. presence of nephropathy;

4. systemic disease or hospitalization for more than 2 weeks in the preceding year;

5. less than 6 menstrual cycles in the past year for post-menarche girls;

6. participation in competitive sport.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

University Hospital of Geneva

Principal Investigators

Farpour-Lambert Nathalie, PD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

Maggio AB, Rizzoli RR, Marchand LM, Ferrari S, Beghetti M, Farpour-Lambert NJ. Physical activity increases bone mineral density in children with type 1 diabetes. Med Sci Sports Exerc. 2012 Jul;44(7):1206-11. doi: 10.1249/MSS.0b013e3182496a25.

Reference Type: DERIVED

PMID: 22246217 (View on PubMed)

Other Identifiers

snf n°63164

Identifier Type: -

Identifier Source: org_study_id