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Cardiorespiratory Responses to Exercise in Elderly

Primary Purpose

Obstructive Sleep Apnea, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cardiopulmonary Exercise Test Protocol
Polysomnography Assessment
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea Syndrome, Aged, Hypertension, Oxygen Consumption, Exercise

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals in stage I or II of systemic hypertension without use of beta-blockers, eutrophics, non-smokers (< 6 months), with no diabetes, or any respiratory or cardiovascular disease and considered irregularly active [15] were enrolled in this study.

Exclusion Criteria:

  • Those with diabetes or any respiratory or cardiovascular disease.

Sites / Locations

  • Bruno Teixeira Barbosa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cardiopulmonary Exercise Test Protocol

Polysomnography Assessment

Arm Description

All subjects performed an incremental cardiopulmonary exercise test (CPET) to maximum exercise tolerance. All the procedures were performed in agreement with the American Thoracic Society/American College of Chest Physicians guidelines for cycle ergometer tests.

All hypertensive subjects were submitted to a polysomnography exam to diagnose OSA. The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA.

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA.

Secondary Outcome Measures

Oxygen Consumption
Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.

Full Information

First Posted
March 22, 2017
Last Updated
October 10, 2017
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT03307928
Brief Title
Cardiorespiratory Responses to Exercise in Elderly
Official Title
Can Obstructive Sleep Apnea Impair Cardiorespiratory Responses to Aerobic Exercise in Hypertensive Elderly?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
June 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Elderly have a high prevalence to systemic arterial hypertension (SAH) and obstructive sleep apnea (OSA). Both comorbidities are closely associated and inflict injury cardiorespiratory capacity. To assess cardiorespiratory responses to the cardiopulmonary exercise test (CPET) among hypertensive elderly with OSA. We enrolled 25 elderly hypertensive in two different groups: without OSA (No-OSA: Apnea/Hypopnea Index (AHI) < 5 events/h; n = 15) and with OSA (OSA: AHI ≥ 15 events/h; n = 13). All subjects underwent a CPET and polysomnographic assessments. After normality and homogeneity evaluations, independent t test and pearson's correlation were performed. The significance level was p ≤ 0.05.
Detailed Description
The sample was randomly recruited from the Lauro Wanderley University Hospital and older people living together centers located in João Pessoa/PB (Brazil). All subjects were submitted to anthropometric assessments (body mass index, neck circumference, hip circumference and waist circumference), polysomnography, echocardiography, cardiopulmonary exercise test (CPET). Moreover, they were submitted to a sleep quality questionnaire (Pittsburgh Sleep Quality Index). Cardiopulmonary Exercise Test Protocol All subjects performed an incremental cardiopulmonary exercise test (CPET) of maximum exercise tolerance. All procedures were performed in agreement with the guidelines of the American Thoracic Society/American College of Chest Physicians for cycle ergometer tests. The CPET was performed on an Inbrasport CG-04 cycle ergometer (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil) with electromagnetic braking. Subjects performed a 5-min warm-up with no resistance (0 W), then the activity rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort. Pulmonary gas exchange variables (VO2, VCO2, minute ventilation [VE], oxygen pulse (O2Pu), respiratory quotient (R), ventilatory efficiency index (VE/VCO2slope), cardiovascular function index (ΔHR/ΔVO2), deviation from oxygen consumption efficiency (OUES), metabolic efficiency index (VO2/ΔWR), blood pressure (BP), heart rate (HR) recovery at first (HRR1) and second (HRR2) minutes were measured breath-by-breath with an on-line gas expiration analysis system (VO2000, MedGraphics, St. Paul, Minnesota, USA). Peak values were established by the highest values achieved during effort. Polysomnography Assessment All hypertensive subjects were submitted to a polysomnography exam to diagnose OSA. OSA diagnosis was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA. The assessment was carried out during an entire night of sleep in the participant's residence without the use of sedatives. The variables were monitored by an Embletta portable respiratory monitor (Embla, Embletta® Gold, EUA), previously validated and in agreement with manufacturer's instructions. The Embletta monitor is capable to continuously monitor pulse oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring episodes. Additionally, HR was continually measured by the analysis of pulse waves by oximetry. Finally, brain and muscle activities were monitored by electrodes, and oxygen desaturation (O2D) was defined as the amount of reduction in O2S at 4%/h. Echocardiography All subjects performed the two-dimensional color Doppler echocardiogram (iE33® - Philips Electronics, Netherlands) before the CPET. Final systolic and diastolic diameters of the left ventricle and the diastolic thickness of the posterior wall of the left ventricle were measured from the short-axis view, and ejection fraction was obtained from these measures. This exam was conducted by an experienced cardiologist, who was blinded to group allocation. Sleep Quality The subjective sleep quality was assessed by the Pittsburgh Sleep Quality Index, which consists of 19 questions grouped into 7 different components (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of medications, and diurnal dysfunction). The classifications depended upon the scores reached in each question (from 0 to 3); ranging from 0 - 4: good subjective sleep quality; 5 - 10: bad subjective sleep quality; and 11 or higher: indicates the presence of at least one sleep disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypertension
Keywords
Obstructive Sleep Apnea Syndrome, Aged, Hypertension, Oxygen Consumption, Exercise

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were divided into two groups: (1) hypertension without OSA (NO-OSA group; AHI < 5 events/h; n = 15) and (2) hypertension with OSA (OSA group: AHI ≥ 15 events/h; n = 13).
Masking
ParticipantInvestigator
Masking Description
The investigator did not have access to the exams that the volunteers realized, either they have access to what they were doing or the order of the exams.
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiopulmonary Exercise Test Protocol
Arm Type
Experimental
Arm Description
All subjects performed an incremental cardiopulmonary exercise test (CPET) to maximum exercise tolerance. All the procedures were performed in agreement with the American Thoracic Society/American College of Chest Physicians guidelines for cycle ergometer tests.
Arm Title
Polysomnography Assessment
Arm Type
Experimental
Arm Description
All hypertensive subjects were submitted to a polysomnography exam to diagnose OSA. The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiopulmonary Exercise Test Protocol
Intervention Description
The CPET was performed in a cycle ergometer with electromagnetic braking using an Inbrasport (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil). Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography Assessment
Intervention Description
The polysomnography assessment was carried out during an entire night of sleep in the participant's residence with no use of sedatives. The variables were monitored by an Embletta portable respiratory monitor (Embla, Embletta® Gold, EUA), previously validated, and in agreement with manufacturer's instructions. The Embletta monitor was capable to monitor continuously the pulse oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring episodes. Additionally, HR was continually measured by the analysis of pulse waves by oximetry. Finally, brain and muscle activities were monitored by electrodes and oxygen desaturation (O2D) was defined as the amount of reduction in O2S in 4%/h.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
The OSA diagnose was confirmed by the apnea/hypopnea index (AHI) and classified as follows: AHI < 5 events/h, absence of OSA; 5 ≤ AHI ≤ 15 events/h, low OSA; 15 ≤ AHI ≤ 30 events/h, moderate OSA; AHI > 30 events/h, severe OSA.
Time Frame
A entire night sleep, an average of 8 yours.
Secondary Outcome Measure Information:
Title
Oxygen Consumption
Description
Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.
Time Frame
A entire procedure (approximately 10 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals in stage I or II of systemic hypertension without use of beta-blockers, eutrophics, non-smokers (< 6 months), with no diabetes, or any respiratory or cardiovascular disease and considered irregularly active [15] were enrolled in this study. Exclusion Criteria: Those with diabetes or any respiratory or cardiovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Barbosa, Master
Organizational Affiliation
Centro Universitário de João Pessoa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bruno Teixeira Barbosa
City
Joao Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051420
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiorespiratory Responses to Exercise in Elderly

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