Cardiorespiratory Responses to Exercise in Elderly

NCT03307928 | Completed

• 1 other identifier: 48423815.1.0000.5188
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Hypertension

Keywords

Obstructive Sleep Apnea Syndrome; Aged; Hypertension; Oxygen Consumption; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  A entire night sleep, an average of 8 yours.

Secondary Outcomes (1)

• Oxygen Consumption

  A entire procedure (approximately 10 minutes)

Study Arms (2)

Cardiopulmonary Exercise Test Protocol

EXPERIMENTAL

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; Diagnostic Test: Polysomnography Assessment

Polysomnography Assessment

EXPERIMENTAL

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; Diagnostic Test: Polysomnography Assessment

Interventions

Cardiopulmonary Exercise Test Protocol DIAGNOSTIC_TEST

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.

Cardiopulmonary Exercise Test Protocol; Polysomnography Assessment

Polysomnography Assessment DIAGNOSTIC_TEST

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.

Cardiopulmonary Exercise Test Protocol; Polysomnography Assessment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those with diabetes or any respiratory or cardiovascular disease.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Bruno Teixeira Barbosa

João Pessoa, Paraíba, 58051420, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Bruno Barbosa, Master

  Centro Universitário de João Pessoa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: October 12, 2017
• Study Start: November 1, 2015
• Primary Completion: March 31, 2016
• Study Completion: June 15, 2016
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)