The Role of Physical Activity in the Treatment of Children With Type 1 Diabetes.
4301
Randomized,Controlled,Open,Cross-Over Intervention Study for Evaluating the Role of Physical Activity in the Treatment of Children With Type 1 Diabetes.
1 other identifier
interventional
2,007
1 country
1
Brief Summary
Randomized, controlled, open, comparative intervention study in two groups, each consisting of 25 children with type 1 diabetes that will undergo twelve weeks of exercise program (intensive arm) and twelve weeks of regular activity (non intensive arm) separated by four week of washout period. The study will be conducted in a crossover manner: one group starting with the intensive arm followed by the non intensive arm and vice versa. Blood glucose, HbA1C, Fructosamine, 3 days continuous glucose monitoring system (CGMS), total daily insulin dose, fasting lipid profile, body impedance and BMR will be measured. Self esteem and quality of life questionnaires will be filled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 26, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJune 26, 2007
June 1, 2007
June 25, 2007
June 25, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HbA1C
0,3 monthes
fructosamine
0,3 monthes
Secondary Outcomes (3)
Body composition & BMR
0,3 monthes
Self esteem & QOL questionnaires
o, 3 monthes
3 days CGMS & SBGM profile
0,3 monthes
Interventions
Eligibility Criteria
You may qualify if:
- Type I diabetic children
- Tanner stage II-IV
- Patients of the Schneider's national institute of childhood diabetes. Duration of diabetes
- more than one year.
- HbA1C between 8 and 12 at time 0.
- Mandatory 4 daily self blood glucose measurements and daily recording of adverse events.
- A signed informed consent of the parents and child.
You may not qualify if:
- Additional chronic significant disease such as cardiac, liver, renal disease .
- Children who exercise regularly more than 180 min per week.
- Cardiac symptoms: history of chest pain , syncope , palpitations or dyspnea during exercise.
- Eating disorders.
- Participation in a study during the past month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schnider children's medical center
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ravital Nimri, MD
Rabin Medical Center
- PRINCIPAL INVESTIGATOR
Moshe Phillip, Prof
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 26, 2007
Study Start
July 1, 2007
Study Completion
July 1, 2009
Last Updated
June 26, 2007
Record last verified: 2007-06