NCT07433790

Brief Summary

This randomized controlled trial aims to compare the effects of mat Pilates combined with paced breathing versus mat Pilates combined with diaphragmatic breathing on stress, anxiety, cardiopulmonary endurance, dyspnea, and quality of life in patients with Stage II hypertension. Participants will be recruited from the Physiotherapy Department of the University of Lahore Teaching Hospital. Outcome measures will include DASS-21, 6-Minute Walk Test (6MWT), Modified Borg Dyspnea Scale, and SF-12 Health Survey. The intervention will be conducted three times per week for six weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 19, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

Mat PilatesPaced BreathingDiaphragmatic BreathingBreathing ExercisesCardiopulmonary Endurance6-Minute Walk Test

Outcome Measures

Primary Outcomes (1)

  • Stress and Anxiety Levels (DASS-21)

    Stress and anxiety levels will be assessed using the Depression Anxiety Stress Scale - 21 items (DASS-21). Each subscale consists of 7 items scored on a 4-point Likert scale (0 = Did not apply to me at all to 3 = Applied to me very much or most of the time). Scores are multiplied by 2 to calculate final subscale scores. Higher scores indicate greater psychological distress.

    Baseline and at 6 weeks

Secondary Outcomes (3)

  • Cardiopulmonary Endurance (6-Minute Walk Test)

    Baseline and at 6 weeks

  • Dyspnea Severity (Modified Borg Dyspnea Scale)

    Baseline and at 6 weeks

  • Health-Related Quality of Life (SF-12)

    Baseline and at 6 weeks

Study Arms (2)

Mat Pilates + Paced Breathing

EXPERIMENTAL

Participants assigned to this arm will receive a supervised mat Pilates program combined with paced breathing exercises, performed three times per week on alternate days for six weeks. Each session will last approximately 45-60 minutes.

Behavioral: Paced Breathing

Mat Pilates + Diaphragmatic Breathing

EXPERIMENTAL

Participants assigned to this arm will receive a supervised mat Pilates program combined with diaphragmatic breathing exercises, performed three times per week on alternate days for six weeks. Each session will last approximately 45-60 minutes.

Other: Mat Pilates

Interventions

Standardized mat-based Pilates exercises focusing on breathing control, core stability, postural alignment, flexibility, and strengthening. Sessions will be supervised and conducted three times per week on alternate days for six weeks, with each session lasting approximately 45-60 minutes.

Mat Pilates + Diaphragmatic Breathing
Paced BreathingBEHAVIORAL

Participants will perform paced breathing exercises using a controlled respiratory rate guided by therapist instruction during sessions. Paced breathing will be integrated with mat Pilates sessions, three times per week for six weeks.

Mat Pilates + Paced Breathing

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 40 to 50 years
  • Clinically diagnosed Stage II hypertension confirmed by a qualified healthcare provider
  • On a stable antihypertensive medication regimen for at least 4 weeks
  • Moderate dyspnea levels as measured by the Modified Borg Dyspnea Scale
  • Not currently participating in any structured exercise or rehabilitation program
  • Able to understand instructions and complete questionnaires
  • Willing to provide written informed consent

You may not qualify if:

  • Uncontrolled hypertension (e.g., blood pressure greater than 180/110 mmHg)
  • History of recent cardiovascular events (e.g., myocardial infarction within the past 6 months)
  • Severe neurological or musculoskeletal disorders limiting mobility
  • Severe anxiety or stress requiring psychiatric intervention
  • Severe cognitive impairment or communication barriers
  • Currently enrolled in another clinical trial or structured wellness program
  • Any medical contraindication to physical activity as advised by a physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (8)

  • Batista, J. P., Tavares, J. B., Goncalves, L. F., de Souza, T. C. F., Mariano, I. M., Amaral, A. L., Rodrigues, M. d. L., Matias, L. A. S., Magalhaes Resende, A. P., & Puga, G. M. (2022). Mat Pilates training reduces blood pressure in both well-controlled hypertensive and normotensive postmenopausal women: a controlled clinical trial study. Clinical and Experimental Hypertension, 44(6), 548-556.

    BACKGROUND
  • Bartolain, T. (2024). Short-Term Pilates Exercise Intervention and Its Impact on Functional Movement in Healthy Middle-Aged Adults.

    BACKGROUND
  • Balban, M. Y., Neri, E., Kogon, M. M., Weed, L., Nouriani, B., Jo, B., Holl, G., Zeitzer, J. M., Spiegel, D., & Huberman, A. D. (2023). Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Reports Medicine, 4(1).

    BACKGROUND
  • BAKIR, N., VURAL, P. I., & DEMİR, C. (2024). The Effects of Diaphragmatic Breathing Exercise on Hot Flashes in Menopausal Women during the COVID-19 Pandemic Period: A Randomized Controlled Trial. Gümüshane Üniversitesi Saglik Bilimleri Dergisi, 13(3).

    BACKGROUND
  • Amaral, A. L., Batista, J., Goncalves, L., Tavares, J., Souza, T. C., Mariano, I., Rodrigues, M., Junior, J. C., Araujo, K., & Ribeiro, P. (2021). EFFECTS OF MAT PILATES TRAINING ON BODY COMPOSITION AND CARDIOMETABOLIC MARKERS IN POSTMENOPAUSAL WOMEN WITH MULTIMORBIDITY. Journal of hypertension, 39, e416-e417.

    BACKGROUND
  • Almeida, I. d. S., Andrade, L. d. S., Sousa, A. M. M. d., Junior, G. C., Catai, A. M., Mota, Y. L., & Durigan, J. L. Q. (2022). Is the combination of aerobic exercise with Mat Pilates better than Mat Pilates training alone on autonomic modulation related to functional outcomes in hypertensive women? Secondary analysis of a randomized controlled trial. International Journal of Environmental Research and Public Health, 19(17), 10577.

    BACKGROUND
  • Akpama, T. G. (2024). Study on the influence of socioeconomic factors on hypertension prevalence.

    BACKGROUND
  • Adawiyah, R., & Sinaga, W. (2024). HUBUNGAN GENETIK DAN USIA DENGAN PENYAKIT HIPERTENSI DI PUSKESMAS PASAR MINGGU JAKARTA SELATAN. Mayapada Nursing Journal, 1(1), 15-20.

    BACKGROUND

MeSH Terms

Conditions

HypertensionEssential Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and care providers will not be blinded due to the nature of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups to receive either mat Pilates combined with paced breathing or mat Pilates combined with diaphragmatic breathing for six weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy Student

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

September 15, 2025

Primary Completion

October 15, 2025

Study Completion

November 18, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. This study is being conducted as an academic research project. The informed consent obtained from participants does not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.

Locations