NCT03767556

Brief Summary

The objective of this study will be to evaluate the effects of inspiratory muscle training (IMT) on the physical fitness of obese women It is believed that the application of these exercises helps in the improvement of inspiratory muscle performance, which should improve physical fitness and thus allow a better performance in the activities of daily living.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

October 17, 2018

Last Update Submit

July 22, 2019

Conditions

Keywords

physical testsfunctional capacityspirometrytravelled distancecardiorespiratory fitnessflexibilityrespiratory pressuresdyspnea

Outcome Measures

Primary Outcomes (1)

  • EVALUATION OF LUNG VOLUMES AND CAPACITIES

    Spirometry will be out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). The values extracted will be selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.

    before and after the intervention, for 2 days with a 72-hour interval

Secondary Outcomes (5)

  • EVALUATION OF PHYSICAL ACTIVITY LEVEL

    before and after the intervention, for 2 days with a 72-hour interval

  • 6-MINUTE DEGREE TEST (TD6)

    before and after the intervention, for 2 days with a 72-hour interval

  • INCREMENTAL SHUTTLE WALKING TEST (ISWT)

    before and after the intervention, for 2 days with a 72-hour interval

  • TEST TO SIT AND LIFT

    before and after the intervention, for 2 days with a 72-hour interval

  • EVALUATION OF INSPIRATORY MUSCLE STRENGTH

    before and after the intervention, for 2 days with a 72-hour interval

Study Arms (2)

Control

NO INTERVENTION

This group will not receive intervention

Inspiratory Muscle Training

EXPERIMENTAL

This group, for inspiratory muscle training, will use the Powerbreathe® K5 device. This device will be adjusted with a load of 55% of previously assessed MIP. The volunteer will be instructed to inhale with sufficient force to overcome the resistance of the equipment and subsequently perform a normal expiration. During the 4-week period of respiratory muscle training volunteers will be instructed to perform 2 sets with 30 inspiratory efforts, 5 days a week. The training load will be readjusted on the first day of training each week, after a new reassessment of the PIMax in order to guarantee the overload during inspiratory muscle training.

Procedure: Inspiratory muscle training

Interventions

Powerbreathe® K5

Inspiratory Muscle Training

Eligibility Criteria

Age20 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\> 35 and \<55 kg / m²
  • with clinical stability
  • suitable for physical tests
  • acceptance to participate in the study

You may not qualify if:

  • women with reports of decompensated heart disease
  • chronic obstructive pulmonary disease and asthma
  • musculoskeletal and / or neuromuscular changes,
  • which make it impossible to perform the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Metodista de Piracicaba (UNIMEP)

Piracicaba, São Paulo, 13400911, Brazil

Location

MeSH Terms

Conditions

Respiratory InsufficiencyDiabetes MellitusHypertensionDyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eli M Pazzianoto-Forti, Phd

    Universidade Metodista de Piracicaba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigador

Study Record Dates

First Submitted

October 17, 2018

First Posted

December 6, 2018

Study Start

December 15, 2018

Primary Completion

May 21, 2019

Study Completion

June 8, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations