DyslipidemiasNCT03307031
The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.
A study testing High Volume Group and Low Volume Group in people with Dyslipidemias, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- High Volume Group and Low Volume Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 13 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dyslipidemic, postmenopausal and sedentary.
Who cannot join
- Women taking statins and smokers.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Dyslipidemias
- Being tested
- High Volume Group, Low Volume Group, Control Group
- Keywords
- training volume, elderly, lipid profile, postmenopausal
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Volume GroupOther
Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.
Low Volume GroupOther
Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
Control GroupOther
Did not exercise, during 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Volume Group | Experimental | Performed four weekly sessions, during 10 weeks with 45 to 55 minutes per session. Receives: Other: High Volume Group |
| Low Volume Group | Experimental | Performed only twice a week, during 10 weeks with 45 to 55 minutes per session. Receives: Other: Low Volume Group |
| Control Group | Placebo comparator | Did not exercise, during 10 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic outcomes
Cholesterol (mg/dl)
Measured: 10 weeks
Metabolic outcomes
Low-density lipoprotein (mg/dl)
Measured: 10 weeks
Metabolic outcomes
Triglycerides (mg/dl)
Measured: 10 weeks
Metabolic outcomes
High-density lipoprotein (mg/dl)
Measured: 10 weeks
Metabolic outcomes
TC/HDL ratio
Measured: 10 weeks
Secondary outcomes (4)
Secondary outcomes
Systolic blood pressure (mmHg)
Measured: 10 weeks
Secondary outcomes
Diastolic blood pressure (mmHg)
Measured: 10 weeks
Secondary outcomes
Functional physical fitness
Measured: 10 weeks
Secondary outcomes
Quality of life
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start1 Mar 2017
- Primary completion28 Jul 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A CONTROLLED CLINICAL TRIAL
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Fernando Martins Kruel, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307031
- Sponsor's protocol ID
- 1.990.955
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03307031
- Acronym / sponsor ID
- 1.990.955
- Conditions
- Dyslipidemias
- Keywords
- training volume, elderly, lipid profile, postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A CONTROLLED CLINICAL TRIAL
| Arm | Type | Receives |
|---|---|---|
| High Volume Group | Experimental | Other: High Volume GroupPerformed four weekly sessions, during 10 weeks with 45 to 55 minutes per session. |
| Low Volume Group | Experimental | Other: Low Volume GroupPerformed only twice a week, during 10 weeks with 45 to 55 minutes per session. |
| Control Group | Placebo comparator | Other: Control GroupDid not exercise, during 10 weeks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dyslipidemic, postmenopausal and sedentary.
Key exclusion criteria (1 listed)
- Women taking statins and smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Volume GroupPerformed four weekly session, during 10 weeks with 45 to 55 minutes per session. | Other | High Volume Group |
| Low Volume GroupPerformed only twice a week, during 10 weeks with 45 to 55 minutes per session. | Other | Low Volume Group |
| Control GroupDid not exercise, during 10 weeks. | Other | Control Group |
Primary outcome
Metabolic outcomes
Time frame: 10 weeks
Cholesterol (mg/dl)
Metabolic outcomes
Time frame: 10 weeks
Low-density lipoprotein (mg/dl)
Metabolic outcomes
Time frame: 10 weeks
Triglycerides (mg/dl)
Metabolic outcomes
Time frame: 10 weeks
High-density lipoprotein (mg/dl)
Metabolic outcomes
Time frame: 10 weeks
TC/HDL ratio
4 secondary outcomes
Secondary outcomes
Time frame: 10 weeks
Secondary outcomes
Time frame: 10 weeks
Secondary outcomes
Time frame: 10 weeks
Secondary outcomes
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Volume Group and Low Volume Group in people with Dyslipidemias, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic outcomes (time frame: 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.