The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
1 other identifier
interventional
30
1 country
1
Brief Summary
This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.
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 Jun 2016
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
May 31, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 9, 2016
August 1, 2016
1.5 years
May 31, 2016
August 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea hypopnea index
measured by portable polysomnography \[in events/hour\]
12 weeks
Secondary Outcomes (9)
sleepiness
12 weeks
sleep quality
12 weeks
cognitive function
12 weeks
motor task
12 weeks
executive function measured by Trail Making Test
12 weeks
- +4 more secondary outcomes
Study Arms (2)
Inspiratory muscle training (IMT)
EXPERIMENTALParticipants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Sham IMT
PLACEBO COMPARATORParticipants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Interventions
Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center
Eligibility Criteria
You may qualify if:
- Heart failure patients with obstructive sleep apnea- hypopnea
- Heart failure patients without sleep apnea
- Left ventricle fraction ejection \< 51 % for men and \< 53% for woman
- Must be clinically stable
- New York Heart Association I, II and III
- Without changes in medication for the last three months.
You may not qualify if:
- Unstable angina
- Atrial fibrillation
- Acute myocardial infarction (\<6 months)
- Recent heart surgery (\<6 months)
- Chronic metabolic disease
- Infectious disease
- Anemia
- Severe hypoxemia
- Neuromuscular disease
- Diabetes mellitus
- Obesity
- Use of continuous positive airway pressure
- Smoking
- Pulmonary disease (forced vital capacity \<80% of predicted and / or forced expiratory volume in one second \<70% predicted).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cruz Alta
Cruz Alta, Rio Grande do Sul, 9800050, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carine C Callegaro, PhD
University of Cruz Alta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 9, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
August 9, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
The volunteers will receive the results of the evaluations pre and post-intervention by the of the study.