Cardiorespiratory Responses to Exercise in Elderly

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307928
• Other study ID #: 48423815.1.0000.5188
• Status: Completed
• Phase: N/A
• First received: March 22, 2017
• Last updated: October 10, 2017
• Start date: November 1, 2015
• Est. completion date: June 15, 2016

Study information

• Verified date: October 2017
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 15, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Bruno Teixeira Barbosa	Joao Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	A entire procedure (approximately 10 minutes)