An interventional study of Treadmill Training (Moderate-intensity continuous training) and Pilates Breathing in PRE-HYPERTENSION, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
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.
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's planned enrollment of 45 is below the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Foundation University Islamabad is the lead sponsor of 255 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will perform moderate-intensity continuous treadmill training combined with pilates breathing exercises three times per week for six weeks.
Other: Pilates Breathing
Participants will perform moderate-intensity continuous treadmill training combined with diaphragmatic breathing exercises three times per week for six weeks.
Other: Diaphragmatic Breathing
Participants will perform moderate-intensity continuous treadmill training only, three times per week for six weeks.
Other: Treadmill Training (Moderate-intensity continuous training)
70% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 06 weeks
Started Feb 2026 (actual). Primary completion is estimated for May 2026, 2 months after the start.
Of 56 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's planned 2 months is below that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
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