Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients with Resistant Hypertension (RAP)

February 18, 2025 updated by: AGIR à Dom

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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.

  3. 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.
  4. 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
        • Contact:
        • Contact:
          • Caroline Minville, MD
        • Contact:
          • Frédéric Sériès, MD
        • Contact:
          • Isabelle Boutin, MD
        • Contact:
          • François Maltais, MD
  • France
      • La Tronche, France, 38700
        • Recruiting
        • Hopital Universitaire de Grenoble
        • Contact:
        • Contact:
        • Contact:
          • Jean-Louis Pépin, Pr MD PhD
        • Contact:
          • Renaud Tamisier, Pr MD PhD
        • Contact:
          • Patrick Lévy, Pr MD PhD
        • Contact:
          • Jean-Philippe Baguet, Pr MD PhD
        • Contact:
          • Sandrine Launois, MD PhD
        • Contact:
          • Olivier Ormezzano, MD PhD
      • Toulouse, France, 31300
        • Recruiting
        • Clinique Pasteur
        • Contact:
        • Contact:
          • Atul Pathak, MD PhD
        • Contact:
          • Laurence Adrover, MD PhD
        • Contact:
          • Nicolas Combes, MD PhD
        • Contact:
          • Isabelle Billiart, MD PhD
        • Contact:
          • David Attias, MD PhD
        • Contact:
          • Pierre Morinet, MD PhD
  • Switzerland
      • Genève, Switzerland
        • Withdrawn
        • Hôpitaux Universitaires de Genève
      • Lausanne, Switzerland
        • Withdrawn
        • Centre Hospitalier Universitaire Vaudois

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity
Obstructive sleep apnea and resistant hypertension controlled + physical activity
Other: Physical activity
Physical activity will carry out 3 times per week during 12 weeks for intervention arm
No Intervention: Control Group
Obstructive sleep apnea and resistant hypertension controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To baseline at 12 weeks
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
To baseline at 12 weeks
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
To baseline at 12 weeks
pulse wave velocity
Time Frame: To baseline at 12 weeks
pulse wave velocity
To baseline at 12 weeks
Change in physical activity : Metabolic Equivalents (METS)
Time Frame: To baseline at 12 weeks
Change in physical activity : Metabolic Equivalents (METS)
To baseline at 12 weeks
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
To baseline at 12 weeks
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
To baseline at 12 weeks

Collaborators and Investigators

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

Sponsor

AGIR à Dom

Collaborators

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Louis Pépin, Pr MD PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

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)

March 26, 2015

Primary Completion (Estimated)

February 18, 2025

Study Completion (Estimated)

February 18, 2025

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimated)

February 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-AGIR-04

Drug and device information, study documents

product manufactured in and exported from the U.S.

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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