PRE-HYPERTENSIONNCT07529821
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 study testing Treadmill Training (Moderate-intensity continuous training), Pilates Breathing and Diaphragmatic Breathing in people with PRE-HYPERTENSION, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- PRE-HYPERTENSION
- What is being tested?
- Treadmill Training (Moderate-intensity continuous training), Pilates Breathing and Diaphragmatic Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Islamabad
Sana Bashir, 03218529475, drsana.bashir@fui.edu.pk
About this study
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.
Read the detailed description
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.
- Conditions
- PRE-HYPERTENSION
- Being tested
- Treadmill Training (Moderate-intensity continuous training), Pilates Breathing, Diaphragmatic Breathing
- Keywords
- Pre-hypertension, Pilates Breathing, Diaphragmatic Breathing, Treadmill training, Pulmonary Function, Chest expansion, Quality of life
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill Training (Moderate-intensity continuous training)Other
70% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.
Pilates BreathingOther
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 BreathingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diaphragmatic Breathing |
| Treadmill training | Active comparator | Participants will perform moderate-intensity continuous treadmill training only, three times per week for six weeks. Receives: Other: Treadmill Training (Moderate-intensity continuous training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 06 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start28 Feb 2026
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRE-HYPERTENSIONStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529821
- Sponsor's protocol ID
- FUCP/CTR/2026/02
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07529821
- Acronym / sponsor ID
- FUCP/CTR/2026/02
- Conditions
- PRE-HYPERTENSION
- Keywords
- Pre-hypertension, Pilates Breathing, Diaphragmatic Breathing, Treadmill training, Pulmonary Function, Chest expansion, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treadmill training with Pilates breathing | Experimental | Other: Pilates BreathingParticipants will perform moderate-intensity continuous treadmill training combined with pilates breathing exercises three times per week for six weeks. |
| Treadmill training with diaphragmatic breathing | Experimental | Other: Diaphragmatic BreathingParticipants will perform moderate-intensity continuous treadmill training combined with diaphragmatic breathing exercises three times per week for six weeks. |
| Treadmill training | Active comparator | Other: Treadmill Training (Moderate-intensity continuous training)Participants will perform moderate-intensity continuous treadmill training only, three times per week for six weeks. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Diagnosed hypertension (≥140/90 mmHg)
- Cardiopulmonary diseases (COPD, asthma, CAD, heart failure)
- Musculoskeletal conditions preventing exercise
- Neurological disorders
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill Training (Moderate-intensity continuous training)70% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks. | Other | Treadmill training |
| Pilates BreathingControlled 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. | Other | Treadmill training with Pilates breathing |
| Diaphragmatic BreathingSlow 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. | Other | Treadmill training with diaphragmatic breathing |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Training (Moderate-intensity continuous training), Pilates Breathing and Diaphragmatic Breathing in people with PRE-HYPERTENSION, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iqra Zahid, MSPT-CPT (03310174987, iqrazahid31801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (SBP and DBP) (time frame: 06 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.