Effect of Inspiratory Muscle Training
MARITSA
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to evaluate the effect of inspiratory muscle training on sleep apnea in the elderly. The patients screened will be randomized and allocated into two groups, intervention and control. In the intervention group, the patients will perform the exercises with the inspiratory muscular training apparatus called Powerbreathe with progressive load, according to its inspiratory muscular force. The control group will perform the same exercises, with the same apparatus, but without load.
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 Apr 2016
Typical duration 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
Study Start
First participant enrolled
April 5, 2016
CompletedFirst Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2018
CompletedJune 19, 2017
June 1, 2017
1.9 years
March 23, 2017
June 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of inspiratory exercise on apnea-hypopnea index in elderly patients with sleep apnea.
Impact of inspiratory muscle training on apnea-hypopnea index in elderly patients with sleep apnea. The measurement will be taken before and after the training. The measurement is apnea-hypopnea index through polysomnograph
8 weeks
Secondary Outcomes (2)
Effect of inspiratory training on maximal inspiratory and expiratory pressures
8 weeks
Effect of inspiratory muscle training on diaphragm thickness
8 weeks
Study Arms (2)
Intervention
EXPERIMENTALIntervention: Exercises wih load Device: "Powerbreathe"
Control
PLACEBO COMPARATORControl: Exercises without load
Interventions
The device in which the breathing exercises will be performed will be adjusted with progressive loading aiming to improve muscular strength
The device in which the breathing exercises will be performed will not be adjusted with progressive loading.
Eligibility Criteria
You may qualify if:
- Age between 65 and 80 years
- Both genders
- Not be treating apnea with AHI between 10 and 30
- Do not tolerate or not have access to CPAP with any AHI
- To consent to participate in the research
You may not qualify if:
- Treatment for sleep apnea
- Severe chronic illness
- IAH greater than 35
- Uncontrolled arterial hypertension
- Acute myocardial infarction
- Recent upper airway trauma
- High performance athletes
- Medications with effect on the central nervous system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Denis Martinez
PhD of Graduate Program in Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The investigator will not know the final result of the tests performed until the end of the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
June 19, 2017
Study Start
April 5, 2016
Primary Completion
March 9, 2018
Study Completion
May 10, 2018
Last Updated
June 19, 2017
Record last verified: 2017-06