Cardiorespiratory Responses to Exercise in Elderly

October 10, 2017 updated by: Bruno Teixeira Barbosa, Federal University of Paraíba

Can Obstructive Sleep Apnea Impair Cardiorespiratory Responses to Aerobic Exercise in Hypertensive Elderly?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • Joao Pessoa, Paraíba, Brazil, 58051420
        • Bruno Teixeira Barbosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cardiopulmonary Exercise Test Protocol
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.
Diagnostic test: Cardiopulmonary Exercise Test Protocol
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.
Diagnostic test: Polysomnography Assessment
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.
Experimental: Polysomnography Assessment
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.
Diagnostic test: Cardiopulmonary Exercise Test Protocol
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.
Diagnostic test: Polysomnography Assessment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index
Time Frame: A entire night sleep, an average of 8 yours.
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.
A entire night sleep, an average of 8 yours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxygen Consumption
Time Frame: A entire procedure (approximately 10 minutes)
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.
A entire procedure (approximately 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Paraíba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno Barbosa, Master, Centro Universitário de João Pessoa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 48423815.1.0000.5188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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