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NCT Number: NCT07529821

Additional Effects of Pilates Breathing and Diaphragmatic Breathing Combined With Moderate Intensity Continuous Treadmill Training on Blood Pressure, Chest Expansion, Pulmonary Function and Quality Of Life in Pre-hypertensive Patients

Pre-hypertension is defined as systolic blood pressure between 120-139mmHg or diastolic blood pressure between 80-89mmHg and is considered a risk factor for developing hypertension. Early lifestyle interventions such as aerobic exercise and breathing techniques may help prevent progression to hypertension. This randomised controlled trial aims to determine the additional effects of pilates breathing and diaphragmatic breathing combined with moderate-intensity continuous treadmill training on blood pressure, chest expansion, pulmonary function and quality of life in pre-hypertensive patients.

A total of 45 participants will be randomly allocated into three groups:

treadmill training with pilates breathing, tredmill training with diaphragmtic brething and treadmill training alone. The intervention will be conducted for 6 weeks. Outcome measures including blood pressure, pulmonary function, chest expansion and quality of life will be assesed before and after the intervention.

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Key information

Conditions

Pre-Hypertension Cardiovascular Diseases Prehypertension Vascular Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University Islamabad

Islamabad, Pakistan

Location status: Recruiting

Location contact

Sana Bashir

CONTACT

[email protected]

03218529475

About this study

Pre-hypertension is defined as systolic blood pressure between 120-139mmHg or diastolic blood pressure between 80-89mmHg.

This study is a three-arm parallel randomized controlled trial designed to evaluate the additional effects of pilates breathing and diaphragmatic breathing combined with moderate-intensity continuous treadmill training (MICT) in individuals with prehypertension.

A total of 45 participants aged 20-55 years diagnosed with prehypertension will be recruited from the Rehabilitation OPD of Fauji Foundation Hospital Rawalpindi. Participants will be randomly allocated into three groups:

Group A (Pilates breathing + treadmill training), Group B (Diaphragmatic breathing + treadmill training), and Group C (Treadmill training only). The intervention will be performed three times per week for six weeks. Treadmill training will follow a moderate-intensity continuous training protocol based on 55-70% of maximum heart rate. Breathing exercises will be performed for 10-15 minutes per session. Data will be analyzed using SPSS software.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prehypertensive individuals (SBP 120-139 mmHg or DBP 80-89 mmHg)
  • Age 20-55 years
  • Both male and female
  • Sedentary individuals according to IPAQ
  • Willing to participate and provide informed consent

Exclusion criteria

  • Diagnosed hypertension (≥140/90 mmHg)
  • Cardiopulmonary diseases (COPD, asthma, CAD, heart failure)
  • Musculoskeletal conditions preventing exercise
  • Neurological disorders
  • Pregnancy
  • Participation in structured exercise in last 3 months

Treatment and study plan

Treadmill Training (Moderate-intensity continuous training)

Other

70% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.

Pilates Breathing

Other

Controlled lateral breathing technique focusing on rib cage expansion and core activation performed for 10-15 minutes, with low intensity, the perceived effort should be 3-4/10, with 3 days/week. A 06 weeks protocol will be followed.

Steps: Patient in neutral spine position and hands placed on rib cage and abdomen. Inhale deeply expanding the ribs laterally. Exhale drawing the navel inward to engage core muscles.

Diaphragmatic breathing

Other

Slow deep breathing emphasizing diaphragmatic movement performed for 10-15 minutes, with low intensity, the perceived effort should be 3-4/10, with 3 days/week. A 06 weeks protocol will be followed.

Steps: Patient in supine or in seated position. Place one hand on chest and one below the ribs. Inhale slowly through the nose expanding the abdomen. Exhale through pursed lips, allowing the abdomen to fall inward and chest should remain still.

Primary outcomes

  1. Blood Pressure (SBP and DBP)

    Time frame: 06 weeks

    Evaluation will be performed using an sphygmomanometer. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) will be recorded in millimeters of mercury (mmHg) under standardized conditions after adequate rest in a seated position.

    Blood pressure values will be recorded as continuous variables. Higher values indicate worse cardiovascular status, while lower values indicate improvement in blood pressure control.

  2. Chest Expansion

    Time frame: 06 weeks

    Evaluation will be performed by measuring chest expansion using a measuring tape at three anatomical levels: axillary, nipple, and xiphoid. Measurements will be taken as the difference (in centimeters, cm) between maximum chest circumference at full inspiration and at full expiration at each level.

    Higher values indicate greater chest wall mobility and improved respiratory function, whereas lower values indicate restricted chest expansion.

  3. Pulmonary Function Test

    Time frame: 06 weeks

    Evaluation will be performed using a spirometer machine in accordance with standard guidelines. The parameters assessed will include Forced Expiratory Volume in 1 second (FEV₁), Forced Vital Capacity (FVC), and FEV₁/FVC ratio. Values will be recorded in liters (L) and as percentage of predicted values (%) based on age, sex, height, and ethnicity.

    Higher values of FEV₁ and FVC indicate better pulmonary function, while a higher FEV₁/FVC ratio indicates reduced airway obstruction and improved respiratory status.

Study contacts

Contact information is provided by the study sponsor or research team.

Iqra Zahid, MSPT-CPT

CONTACT

[email protected]

03310174987

Sana Bashir, PhD*

CONTACT

[email protected]

+923218529475

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 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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