NCT02845544

Brief Summary

The study of the behavior of the mechanisms of body balance with a workout based on the Pilates method can facilitate the development of more accurate rehabilitation approaches. However, there is still little scientific information on its effects on the locomotor system and it's necessary to search for new methods to evaluate its strategies more specifically. Thus, this study aims to determine whether an exercise program based on Pilates method has influence on the static and dynamic postural balance of sedentary adults. This is a randomized controlled trial, which will be developed with an initial sample of 20 subjects of both sexes, aged between 18 and 30 years, divided into two groups: a control group and an experimental group. Participants with physical activity time up to 150 minutes per week will be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those who have no experience with the Pilates method. In the experimental group a workout program will be done for 6 weeks with individual classes including exercises based on the Pilates method, during 1-hour, twice a week. Assessments will be made prior and after the training program with anamnesis, anthropometric measurements and also the Balance Error Scoring System and the Star Excursion Balance Test Y to assess postural balance. During the tests and training program exercises the muscle activity of paraspinals and transversus abdominis will be analyzed using surface electromyography (sEMG), and body mass center displacement will be measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The data will be entered in a spreadsheet and statistically tested with SPSS software. The tests will include the comparison of means, association, correlation and effect size, which will be chosen according to the distribution of the data and will use the 5% significance level for all tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

May 3, 2016

Last Update Submit

September 7, 2016

Conditions

Keywords

Postural Balance

Outcome Measures

Primary Outcomes (1)

  • Static and dynamic postural balance with body mass displacement tracking

    Postural balance will be assessed during standing position and walking while wearing a triaxial accelerometer for the body mass displacement tracking

    up to 6 weeks

Secondary Outcomes (1)

  • Surface Electromyography of the abdominal and low-back muscles

    up to 6 weeks

Study Arms (2)

Experimental group - Pilates

EXPERIMENTAL

A Pilates-based exercises program of 6 weeks' duration

Other: Pilates-based exercises

Control group - no exercises

NO INTERVENTION

Interventions

Experimental group - Pilates

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary
  • healthy
  • with no pilates experience

You may not qualify if:

  • Physically active
  • with history of injuries and surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Kinesiology and Functional Evaluation in Federal University of Pernambuco

Recife, Pernambuco, 50.740-600, Brazil

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Marco AB Rodrigues, Ph.D.

    Universidade Federal de Pernambuco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2016

First Posted

July 27, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations