Back to resultsThe Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High Volume Group
Low Volume Group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring training volume, elderly, lipid profile, postmenopausal
Eligibility Criteria
Inclusion Criteria:
- Dyslipidemic, postmenopausal and sedentary.
Exclusion Criteria:
- Women taking statins and smokers.
Sites / Locations
- Adriana Cristine Koch Buttelli
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High Volume Group
Low Volume Group
Control Group
Arm Description
Performed four weekly sessions, 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.
Did not exercise, during 10 weeks.
Outcomes
Primary Outcome Measures
Metabolic outcomes
Cholesterol (mg/dl)
Metabolic outcomes
Low-density lipoprotein (mg/dl)
Metabolic outcomes
Triglycerides (mg/dl)
Metabolic outcomes
High-density lipoprotein (mg/dl)
Metabolic outcomes
TC/HDL ratio
Secondary Outcome Measures
Secondary outcomes
Systolic blood pressure (mmHg)
Secondary outcomes
Diastolic blood pressure (mmHg)
Secondary outcomes
Functional physical fitness
Secondary outcomes
Quality of life
Full Information
NCT ID
NCT03307031
First Posted
September 13, 2017
Last Updated
October 5, 2017
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03307031
Brief Title
The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.
Official Title
The Influence of Pilates Exercises Training Volume on Metabolic, Physical Fitness and Quality of Life Outcomes in Dyslipidemic Women: A Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
training volume, elderly, lipid profile, postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A CONTROLLED CLINICAL TRIAL
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Volume Group
Arm Type
Experimental
Arm Description
Performed four weekly sessions, during 10 weeks with 45 to 55 minutes per session.
Arm Title
Low Volume Group
Arm Type
Experimental
Arm Description
Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Did not exercise, during 10 weeks.
Intervention Type
Other
Intervention Name(s)
High Volume Group
Intervention Description
Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.
Intervention Type
Other
Intervention Name(s)
Low Volume Group
Intervention Description
Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Did not exercise, during 10 weeks.
Primary Outcome Measure Information:
Title
Metabolic outcomes
Description
Cholesterol (mg/dl)
Time Frame
10 weeks
Title
Metabolic outcomes
Description
Low-density lipoprotein (mg/dl)
Time Frame
10 weeks
Title
Metabolic outcomes
Description
Triglycerides (mg/dl)
Time Frame
10 weeks
Title
Metabolic outcomes
Description
High-density lipoprotein (mg/dl)
Time Frame
10 weeks
Title
Metabolic outcomes
Description
TC/HDL ratio
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Secondary outcomes
Description
Systolic blood pressure (mmHg)
Time Frame
10 weeks
Title
Secondary outcomes
Description
Diastolic blood pressure (mmHg)
Time Frame
10 weeks
Title
Secondary outcomes
Description
Functional physical fitness
Time Frame
10 weeks
Title
Secondary outcomes
Description
Quality of life
Time Frame
10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Dyslipidemic, postmenopausal and sedentary.
Exclusion Criteria:
Women taking statins and smokers.
Facility Information:
Facility Name
Adriana Cristine Koch Buttelli
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.
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