NCT03307031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
Last Updated

October 11, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

September 13, 2017

Last Update Submit

October 5, 2017

Conditions

Keywords

training volumeelderlylipid profilepostmenopausal

Outcome Measures

Primary Outcomes (5)

  • Metabolic outcomes

    Cholesterol (mg/dl)

    10 weeks

  • Metabolic outcomes

    Low-density lipoprotein (mg/dl)

    10 weeks

  • Metabolic outcomes

    Triglycerides (mg/dl)

    10 weeks

  • Metabolic outcomes

    High-density lipoprotein (mg/dl)

    10 weeks

  • Metabolic outcomes

    TC/HDL ratio

    10 weeks

Secondary Outcomes (4)

  • Secondary outcomes

    10 weeks

  • Secondary outcomes

    10 weeks

  • Secondary outcomes

    10 weeks

  • Secondary outcomes

    10 weeks

Study Arms (3)

High Volume Group

EXPERIMENTAL

Performed four weekly sessions, during 10 weeks with 45 to 55 minutes per session.

Other: High Volume Group

Low Volume Group

EXPERIMENTAL

Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.

Other: Low Volume Group

Control Group

PLACEBO COMPARATOR

Did not exercise, during 10 weeks.

Other: Control Group

Interventions

Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.

High Volume Group

Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.

Low Volume Group

Did not exercise, during 10 weeks.

Control Group

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dyslipidemic, postmenopausal and sedentary.

You may not qualify if:

  • Women taking statins and smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adriana Cristine Koch Buttelli

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A CONTROLLED CLINICAL TRIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 13, 2017

First Posted

October 11, 2017

Study Start

March 1, 2017

Primary Completion

July 28, 2017

Study Completion

September 13, 2017

Last Updated

October 11, 2017

Record last verified: 2017-08

Locations