Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01538069
Status:
UNKNOWN
Last Update Posted:
2013-08-09
First Post:
2012-02-15
Brief Title:
Heart Failure and Sleep Apnea Exercise Training and Continuous Positive Airway Pressure
Sponsor:
Associação Fundo de Incentivo à Pesquisa
Organization:
Associação Fundo de Incentivo à Pesquisa
Study Overview
Official Title:
Comparison Between Exercise Training and CPAP Treatment for Patients With Heart Failure and Sleep Apnea
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPAP
Brief Summary:
Introduction Heart failure is the result of primary ventricular dysfunction followed by neurohormorais changes distribution of cardiac output peripheral circulation the skeletal and respiratory muscles which determine their clinical and prognosis Despite the advancement in treatment morbidity and mortality remain high Physical training appears as a therapeutic strategy because most of its beneficial effects is by inducing changes in peripheral physiological changes resulting from heart failure Associated factors that may contribute to its progression and worse prognosis now beginning to be studied such as sleep apnea the diagnosis provides important prognostic information and a potential therapeutic option for these patients
Objectives Demonstrate the benefits of physical training for patients with heart failure and sleep apnea and compare treatment with CPAP alone and associated with the exercise program Will also be assessed risk and adherence to physical training
Material and Methods The design will be prospective longitudinal randomized consecutive patients After screening and baseline evaluations the patients will be randomized into Group 1 CPAP n 20 Group 2 CPAP Physical training n 20 Group 3 Physical Training n 20 and Group 4 Control without intervention n 20 Outcomes baseline and 3 months Quality of sleep polysomnography Quality of life Minnesota and SF-36 sexual function QS-M and QS-F and functional capacity cardiopulmonary exercise testing and isokinetic testing Physical training aerobic and resistance exercises three times a week for three months CPAP therapyafter polysomnography for titration with ventilator servo-assisted and outpatient follow monthly for three months
Objectives Demonstrate the benefits of physical training for patients with heart failure and sleep apnea and compare treatment with CPAP alone and associated with the exercise program Will also be assessed risk and adherence to physical training
Material and Methods The design will be prospective longitudinal randomized consecutive patients After screening and baseline evaluations the patients will be randomized into Group 1 CPAP n 20 Group 2 CPAP Physical training n 20 Group 3 Physical Training n 20 and Group 4 Control without intervention n 20 Outcomes baseline and 3 months Quality of sleep polysomnography Quality of life Minnesota and SF-36 sexual function QS-M and QS-F and functional capacity cardiopulmonary exercise testing and isokinetic testing Physical training aerobic and resistance exercises three times a week for three months CPAP therapyafter polysomnography for titration with ventilator servo-assisted and outpatient follow monthly for three months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None