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NCT Number: NCT02057783

Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension

Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a physical activity program will optimize 24-hour blood pressure control in patients with OSA-related resistant hypertension.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec, Canada

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About this study

  • Sleep apnea syndrome, resistant hypertension and cardio-vascular risk. There are many epidemiological and clinical cohort studies demonstrating an increasing cardiovascular risk associated with Obstructive Sleep Apnea Syndrome (OSAS). In epidemiological studies, OSA severity and incident hypertension are linked in a dose-response fashion. This is true even when taking into account usual confounding factors such as age, alcohol, tobacco consumption and body mass index. More specifically, OSAS is the leading cause of refractory hypertension and OSAS prevalence is up to 80% in patients with resistant hypertension.
  • CPAP treatment impact for reducing blood pressure in OSAS patients with resistant hypertension A recent small sample size randomized trial (n=35) demonstrated the positive impact of CPAP in decreasing both clinical and 24-hour ambulatory blood pressure. Compared to the control group, awake systolic/diastolic ambulatory blood pressure monitoring decreased significantly in the continuous positive airway pressure group (Delta: +3.1±3.3 /+2.1±2.7 vs. -6.5±3.3/ 4.5±1.9mmHg in control and CPAP groups respectively, p<0.05). Interestingly, the blood pressure changes were only observed while patients were awake, but not during nocturnal ambulatory blood pressure monitoring (Delta: +2.8±4.5/+1.8±3.5 vs. +1.6±3.5/+0.8±2.9mmHg, p=NS).

HIPARCO Study, the largest Randomized Clinical Trial (RCT) in the field (n=194) recently published in JAMA (9 December 2013) also showed a significant but limited impact of CPAP on blood pressure. In an Intention To Treat analysis, CPAP significantly improved 24-h mean BP (3.0 mmHg; 95% CI 0.3 to 5.8; p=0.031) and DBP (3.2 mmHg; 95% CI 1.0 to 5.4; p=0.005) but not SBP (3.1; 95% CI -0.6 to 6.7; p=0.098). Moreover, patients in the CPAP group had 2.4 (1.2-5.1; p=0.019) times greater probability of recovering their dipper pattern. As CPAP alone is not enough in OSAS to sufficiently improve BP, further studies should address the efficacy of combined therapies in OSAS patients with resistant hypertension.

  • Resistant hypertension and physical activity A study has recently explored the impact of a standardized exercise program in patients suffering from resistant hypertension7. In this RCT, the authors have demonstrated that the group of patients who have benefit from a physical activity program had their systolic and diastolic 24-hour ambulatory blood pressure monitoring decreasing by 6±12 and 3±7 mmHg respectively(p=0.03). Thus, the physical activity implemented in this population enabled a better control of blood pressure values. However the authors do not give any information about the presence of the absence of Sleep Apnea Syndrome (SAS) in this cohort.
  • Study hypothesis:

Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a physical activity program will optimize 24-hour blood pressure control in patients with OSA-related resistant hypertension.

Originality: Up to now no study has assessed the effects of combining physical activity with CPAP treatment in patients with sleep apnea and resistant hypertension. Our work is will be the first aiming at evaluating the benefit of this combination on the control of the systolic blood arterial pressure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with an obstructive sleep apnea (apnea-hypopnea index > or equal to 15)
  • Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
  • Ambulatory patient

Exclusion criteria

  • Acute hepatic failure, biliary cirrhosis, cholestasis
  • Acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)
  • Contraindication to CPAP treatment

Treatment and study plan

Physical activity

Other

Physical activity will carry out 3 times per week during 12 weeks for intervention arm

Primary outcomes

  1. Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Time frame: To baseline at 12 weeks

    Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

Secondary outcomes

  1. diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Time frame: To baseline at 12 weeks

    diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

  2. Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Time frame: To baseline at 12 weeks

    Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring

  3. Change in physical activity: number of hour per day of physical activity

    Time frame: To baseline at 12 weeks

    Change in physical activity: number of hour per day of physical activity

  4. pulse wave velocity

    Time frame: To baseline at 12 weeks

    pulse wave velocity

  5. Change in physical activity : Metabolic Equivalents (METS)

    Time frame: To baseline at 12 weeks

    Change in physical activity : Metabolic Equivalents (METS)

  6. Change in physical activity : Number of steps per day

    Time frame: To baseline at 12 weeks

    Change in physical activity : Number of steps per day

  7. Change in sleep duration: Sleep to lying position duration ratio

    Time frame: To baseline at 12 weeks

    Change in sleep duration: Sleep to lying position duration ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Louis Pépin, Pr MD PhD

CONTACT

[email protected]

Sandrine Bouzon

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

AGIR à Dom

Other

Collaborators

  • University Hospital, Grenoble

Registry information

Official study title

Comparison of Standard Treatment by Continuous Positive Airway Pressure (CPAP) and CPAP Combined to a Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension: RAP Randomized Controlled Trial

Acronym: RAP

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2014
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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