- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307031
The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.
October 5, 2017 updated by: Luiz Fernando Martins Kruel, Federal University of Rio Grande do Sul
The Influence of Pilates Exercises Training Volume on Metabolic, Physical Fitness and Quality of Life Outcomes in Dyslipidemic Women: A Controlled Clinical Trial.
The aim of the present study was to assess the influence of different volumes of Pilates training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and quality of life (QL) outcomes in postmenopausal dyslipidemic women.
In total, 26 women participated in the controlled clinical trial, being allocated into three groups: high volume group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6).
HVG performed four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
Before and after the intervention period, metabolic, BP, PF, QL and cardiovascular risk score (CRS) outcomes were measured.
The results were described by mean values with lower and upper limits (95% confidence interval).
Comparisons between groups and intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post hoc of Bonferroni and significance level of ɑ=0,05.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil
- Adriana Cristine Koch Buttelli
-
-
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
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Dyslipidemic, postmenopausal and sedentary.
Exclusion Criteria:
- Women taking statins and smokers.
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Volume Group
Performed four weekly sessions, during 10 weeks with 45 to 55 minutes per session.
|
Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.
|
Experimental: Low Volume Group
Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
|
Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
|
Placebo Comparator: Control Group
Did not exercise, during 10 weeks.
|
Did not exercise, during 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic outcomes
Time Frame: 10 weeks
|
Cholesterol (mg/dl)
|
10 weeks
|
Metabolic outcomes
Time Frame: 10 weeks
|
Low-density lipoprotein (mg/dl)
|
10 weeks
|
Metabolic outcomes
Time Frame: 10 weeks
|
Triglycerides (mg/dl)
|
10 weeks
|
Metabolic outcomes
Time Frame: 10 weeks
|
High-density lipoprotein (mg/dl)
|
10 weeks
|
Metabolic outcomes
Time Frame: 10 weeks
|
TC/HDL ratio
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary outcomes
Time Frame: 10 weeks
|
Systolic blood pressure (mmHg)
|
10 weeks
|
Secondary outcomes
Time Frame: 10 weeks
|
Diastolic blood pressure (mmHg)
|
10 weeks
|
Secondary outcomes
Time Frame: 10 weeks
|
Functional physical fitness
|
10 weeks
|
Secondary outcomes
Time Frame: 10 weeks
|
Quality of life
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
March 1, 2017
Primary Completion (Actual)
July 28, 2017
Study Completion (Actual)
September 13, 2017
Study Registration Dates
First Submitted
September 13, 2017
First Submitted That Met QC Criteria
October 5, 2017
First Posted (Actual)
October 11, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2017
Last Update Submitted That Met QC Criteria
October 5, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.990.955
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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