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CompletedNCT03307031Updated Oct 11, 2017

The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.

An interventional study of High Volume Group and Low Volume Group in Dyslipidemias, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Brazil. Open to female participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
60 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Dyslipidemias

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Keywords

  • training volume
  • elderly
  • lipid profile
  • postmenopausal
03

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Dyslipidemic, postmenopausal and sedentary.

Exclusion criteria

Exclusion Criteria:

  • Women taking statins and smokers.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    High Volume Group

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

    Other: High Volume Group

  • Experimental
    Low Volume Group

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

    Other: Low Volume Group

  • Placebo comparator
    Control Group

    Did not exercise, during 10 weeks.

    Other: Control Group

Interventions

  • OtherHigh Volume Group

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

  • OtherLow Volume Group

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

  • OtherControl Group

    Did not exercise, during 10 weeks.

05

What researchers measure

Primary outcomes

  1. Metabolic outcomes

    Cholesterol (mg/dl)

    Time frame: 10 weeks

  2. Metabolic outcomes

    Low-density lipoprotein (mg/dl)

    Time frame: 10 weeks

  3. Metabolic outcomes

    Triglycerides (mg/dl)

    Time frame: 10 weeks

  4. Metabolic outcomes

    High-density lipoprotein (mg/dl)

    Time frame: 10 weeks

  5. Metabolic outcomes

    TC/HDL ratio

    Time frame: 10 weeks

Secondary outcomes

  1. Secondary outcomes

    Systolic blood pressure (mmHg)

    Time frame: 10 weeks

  2. Secondary outcomes

    Diastolic blood pressure (mmHg)

    Time frame: 10 weeks

  3. Secondary outcomes

    Functional physical fitness

    Time frame: 10 weeks

  4. Secondary outcomes

    Quality of life

    Time frame: 10 weeks

06

Study locations

1 site
  • Adriana Cristine Koch Buttelli
    Porto Alegre, Rio Grande do Sul, Brazil
07

Registry details

Key details

Study ID
NCT03307031
Lead sponsor
Federal University of Rio Grande do Sul
Responsible party
Luiz Fernando Martins Kruel (Doctor, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Oct 11, 2017
Start date
Mar 1, 2017
Primary completion
Jul 28, 2017
Completion
Sep 13, 2017
Last update
Oct 11, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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