- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07730879
How Wall Squat Exercise Affects Blood Pressure in People With High Blood Pressure and Treated Sleep Apnea (WALLPRESS) (WALLPRESS)
Acute Blood Pressure Responses to Isometric Wall Squat Exercise in Adults With Hypertension and CPAP-Treated Obstructive Sleep Apnea: A Randomized Crossover Trial
This study will look at whether a simple exercise called the isometric wall squat can help lower blood pressure in adults who have both hypertension and obstructive sleep apnoea treated with CPAP. Obstructive sleep apnoea is a condition in which breathing repeatedly stops or becomes shallow during sleep, and it is closely linked to high blood pressure. Although CPAP helps treat sleep apnoea, it usually lowers blood pressure only a little, so additional non-drug strategies may be useful.
The study will compare two situations in the same participants: one session of wall squat exercise and one non-exercise control session. Each participant will take part in both sessions, but the order will be random. This design helps the researchers compare blood pressure changes more fairly within the same person.
Participants will first attend a familiarization session, where the study procedures will be explained and the exercise intensity will be checked. After that, they will complete the two study sessions at home, during their usual CPAP treatment visits. The sessions will be separated by at least 48 hours and completed within one week. Both sessions will be scheduled at the same time of day to reduce the effect of normal daily changes in blood pressure.
The main result the researchers will measure is the average systolic blood pressure during the 12 hours after each session, using ambulatory blood pressure monitoring. This means blood pressure will be measured over time while the participant goes about normal daily activities. The researchers want to find out whether a single session of wall squat exercise produces a greater blood pressure reduction than simply resting without exercise.
This study may help improve understanding of whether isometric exercise can be a practical, low-cost, home-based option to support blood pressure control in people with hypertension and CPAP-treated obstructive sleep apnoea.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fernando Ribeiro, PhD
- Phone Number: +351234372455
- Email: fernando.ribeiro@ua.pt
Study Contact Backup
- Name: Rafael Mariz, Bachelor in Physiotherapy
- Email: rafaelmariz@ua.pt
Study Locations
-
-
-
Braga, Portugal
- Recruiting
- Nippon Sanso Homecare
-
Contact:
- Rafael Mariz, Bachelor
- Phone Number: +351 963299791
- Email: rafaelmariz@ua.pt
-
Principal Investigator:
- Rafael Mariz, Bachelor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-80 years old.
- Diagnosis of hypertension and OSA confirmed by polysomnography or respiratory sleep study.
- Apnea-Hypopnea Index (AHI) of at least 15 events per hour.
- Treatment with CPAP for at least 3 months.
Exclusion Criteria:
- Mean CPAP adherence <4 hours/night over the last month, documented by device download.
- Heart failure.
- Peripheral artery disease.
- Atrial fibrillation.
- Chronic obstructive pulmonary disease.
- Chronic kidney disease.
- History of acute coronary syndrome, stroke, or transient ischemic attack in the previous 12 months.
- Relevant changes in antihypertensive or other cardiovascular pharmacotherapy in the previous 3 months.
- Relevant changes in CPAP prescription in the previous 3 months.
- Any contraindication to exercise according to contemporary ESC/ACSM recommendations (e.g. unstable angina).
- Pregnancy or breastfeeding.
- Neurological and/or orthopaedic conditions that could interfere with exercise (e.g. severe knee osteoarthritis, recent lower-limb surgery).
- Inability to read, understand, or provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isometric Wall Squat
Isometric Wall Squat exercise session plus standard drug therapy
|
4x2-min isometric wall squat contractions separated by 2-min rest periods plus standard drug therapy
Other Names:
|
|
No Intervention: Control
non-exercise control session plus standard drug therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-hour systolic blood pressure
Time Frame: During the 12 hours following the exercise or control session
|
Systolic blood pressure measured by ambulatory blood pressure monitoring every 30 minutes for 12 hours after the exercise or control session
|
During the 12 hours following the exercise or control session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-hour diastolic blood pressure
Time Frame: During the 12 hours following the exercise or control session
|
Diastolic blood pressure measured by ambulatory blood pressure monitoring every 30 minutes for 12 hours after the exercise or control session
|
During the 12 hours following the exercise or control session
|
|
Short-term blood pressure variability
Time Frame: During the 12 hours following the exercise or control session
|
Standard deviation of ambulatory readings over 12 hours post-session
|
During the 12 hours following the exercise or control session
|
|
Pulse pressure
Time Frame: During the 12 hours following the exercise or control session
|
Mean difference between systolic and diastolic ambulatory blood pressure during the 12 hours after the exercise or control session
|
During the 12 hours following the exercise or control session
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events associated with the isometric wall squat exercise session.
Time Frame: From during the session to 72 hours after the exercise session
|
Number and type of adverse events (e.g., skin irritation, limb discomfort, cramps, delayed onset muscle soreness) occurring during and/or after the isometric exercise session, classified by severity (mild, moderate, severe), relationship to the intervention (unrelated to definitely related), and type of event
|
From during the session to 72 hours after the exercise session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fernando Ribeiro, PhD, University of Aveiro, Aveiro, Portugual
- Principal Investigator: Eduardo C Costa, PhD, Federal University of Rio Grande do Norte, Natal, Brazil
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 153-CEIC-UA/2026-M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.