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Completed

NCT Number: NCT07433790

Mat Pilates With Paced Breathing Versus Diaphragmatic Breathing in Stage II Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Stage II Hypertension Vascular Diseases

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

About this study

This study is a randomized controlled trial conducted at the Physiotherapy Department of the University of Lahore Teaching Hospital, Lahore. A total of 63 hypertensive patients will be screened from the Outpatient Department (OPD) after clinical diagnosis by a qualified medical specialist.

Eligible participants who meet inclusion criteria and provide written informed consent will be enrolled using a non-probability purposive sampling technique. Participants will be randomly allocated into two parallel groups using a sealed envelope method to ensure allocation concealment.

Participants in:

Group A:

Will receive mat Pilates exercises combined with paced breathing training.

Group B:

Will receive mat Pilates exercises combined with diaphragmatic breathing training.

Both groups will undergo supervised intervention sessions three times per week on alternate days for a total duration of six weeks. Each session will last approximately 45-60 minutes.

Outcome measures will be assessed at baseline and at the end of the six-week intervention period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

mat pilates

Other

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.

Paced breathing

Behavioral

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.

Primary outcomes

  1. Stress and Anxiety Levels (DASS-21)

    Time frame: Baseline and at 6 weeks

    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.

Secondary outcomes

  1. Cardiopulmonary Endurance (6-Minute Walk Test)

    Time frame: Baseline and at 6 weeks

    Cardiopulmonary endurance will be measured using the 6-Minute Walk Test (6MWT). The total distance walked in meters over six minutes will be recorded. Higher distance indicates improved cardiopulmonary endurance.

  2. Dyspnea Severity (Modified Borg Dyspnea Scale)

    Time frame: Baseline and at 6 weeks

    Dyspnea will be assessed using the Modified Borg Dyspnea Scale, a numerical rating scale ranging from 0 (no breathlessness) to 10 (maximal breathlessness). Higher scores indicate more severe dyspnea.

  3. Health-Related Quality of Life (SF-12)

    Time frame: Baseline and at 6 weeks

    Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12), which evaluates physical and mental health domains. Higher scores indicate better perceived health status.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Effects of Paced Breathing Versus Diaphragmatic Breathing Combined With Mat Pilates on Cardiopulmonary Endurance, Dyspnea, Stress, Anxiety, and Quality of Life in Patients With Stage II Hypertension: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

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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