NCT07529821

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

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 Start

First participant enrolled

February 28, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 27, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Pre-hypertensionPilates BreathingDiaphragmatic BreathingTreadmill trainingPulmonary FunctionChest expansionQuality of life

Outcome Measures

Primary Outcomes (3)

  • Blood Pressure (SBP and DBP)

    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.

    06 weeks

  • Chest Expansion

    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.

    06 weeks

  • Pulmonary Function Test

    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.

    06 weeks

Study Arms (3)

Treadmill training with Pilates breathing

EXPERIMENTAL

Participants will perform moderate-intensity continuous treadmill training combined with pilates breathing exercises three times per week for six weeks.

Other: Pilates Breathing

Treadmill training with diaphragmatic breathing

EXPERIMENTAL

Participants will perform moderate-intensity continuous treadmill training combined with diaphragmatic breathing exercises three times per week for six weeks.

Other: Diaphragmatic Breathing

Treadmill training

ACTIVE COMPARATOR

Participants will perform moderate-intensity continuous treadmill training only, three times per week for six weeks.

Other: Treadmill Training (Moderate-intensity continuous training)

Interventions

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.

Treadmill training with Pilates breathing

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.

Treadmill training with diaphragmatic breathing

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

Treadmill training

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Iqra Zahid, MSPT-CPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having three groups. One group (interventional group) will receive Pilates breathing along with moderate-intensity continuous treadmill training, and the second group (experimental group) will perform diaphragmatic breathing along with moderate-intensity continuous treadmill training, and the third group (control group) will perform only moderate-intensity continuous treadmill training.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 14, 2026

Study Start

February 28, 2026

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

April 14, 2026

Record last verified: 2026-03

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