- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02400515
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals
March 23, 2015 updated by: Andrea Sanches, University of Campinas, Brazil
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic and Hypertensive Individuals
This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.
Study Overview
Detailed Description
This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- having normal physical examinations,
- no participation in regular, moderate or intensive exercise for at least 6 months before the study and
- not be following a diet
Exclusion Criteria:
- the use of insulin and beta-blocker medications and
- the functional inability to perform exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Moderate Exercise
Aerobic physical exercise was applied during 3 months, 3x/week on women with type 2 diabetic.
The evaluation occurred before and after exercise in the same (and only) group, considering that this is a quasi-experimental study.
|
This is a quasi-experimental study and the same group was evaluated before and after the exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose levels
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glucose test.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic and Diastolic blood pressure
Time Frame: 3 months
|
Change in Systolic and Diastolic blood pressure were evaluated before and after physical exercise, during 3 months.
|
3 months
|
Heart Rate measurement
Time Frame: 3 months
|
Change in heart rate was evaluated before, during and after physical exercise, during 3 months.
|
3 months
|
Glycated hemoglobin levels
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glycated hemoglobin test.
|
3 months
|
Proteinuria levels
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for proteinuria test.
|
3 months
|
Triglycerides levels
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for triglycerides test.
|
3 months
|
High Density Level (HDL) Cholesterol levels
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for High Density Level Cholesterol test.
|
3 months
|
Low Density Level (LDL) Cholesterol levels
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Low Density Level Cholesterol test.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary cortisol
Time Frame: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new saliva collection for the salivary cortisol measure.
|
3 months
|
Hospital Anxiety and Depression scale (HADS)
Time Frame: 3 months
|
After 3 months of the physical exercise, the HADS was evaluated.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
March 5, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 27, 2015
Study Record Updates
Last Update Posted (Estimate)
March 27, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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