NCT07730879

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 23, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

isometric exercisewall squatblood pressure

Outcome Measures

Primary Outcomes (1)

  • 12-hour systolic blood pressure

    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 Outcomes (3)

  • 12-hour diastolic blood pressure

    During the 12 hours following the exercise or control session

  • Short-term blood pressure variability

    During the 12 hours following the exercise or control session

  • Pulse pressure

    During the 12 hours following the exercise or control session

Other Outcomes (1)

  • Adverse events associated with the isometric wall squat exercise session.

    From during the session to 72 hours after the exercise session

Study Arms (2)

Isometric Wall Squat

EXPERIMENTAL

Isometric Wall Squat exercise session plus standard drug therapy

Other: Isometric Wall Squat

Control

NO INTERVENTION

non-exercise control session plus standard drug therapy

Interventions

4x2-min isometric wall squat contractions separated by 2-min rest periods plus standard drug therapy

Also known as: wall squat
Isometric Wall Squat

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nippon Sanso Homecare

Braga, Portugal

RECRUITING

MeSH Terms

Conditions

HypertensionSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Fernando Ribeiro, PhD

    University of Aveiro, Aveiro, Portugual

    PRINCIPAL INVESTIGATOR
  • Eduardo C Costa, PhD

    Federal University of Rio Grande do Norte, Natal, Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Ribeiro, PhD

CONTACT

Rafael Mariz, Bachelor in Physiotherapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator Professor with Habilitation

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in the publication will be shared upon reasonable request after study completion.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Available after publication of the primary results and ending 5 years thereafter.
Access Criteria
De-identified individual participant data and supporting documents will be available to qualified researchers upon reasonable request for scientifically valid purposes. Requests will be reviewed and approved by the study team, and access will be granted after agreement on data use, ethical compliance, and confidentiality protections. Data will be shared in de-identified form only, via secure transfer or a controlled-access repository.

Locations