Effects of Respiratory Muscle Training in Obese Women
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedStudy Start
First participant enrolled
December 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2019
CompletedJuly 24, 2019
July 1, 2019
5 months
October 17, 2018
July 22, 2019
Conditions
Keywords
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 INTERVENTIONThis group will not receive intervention
Inspiratory Muscle Training
EXPERIMENTALThis 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.
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eli M Pazzianoto-Forti, Phd
Universidade Metodista de Piracicaba
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