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HypertensionNCT07529834

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

A study testing Cycling Training (Moderate-intensity continuous training), Pilates Breathing and Diaphragmatic Breathing in people with Hypertension, run by Foundation University Islamabad at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Hypertension or high blood pressure is defined as when the pressure in the blood vessels is too high. According to Joint National Committee 8 (JNC 8) Guidelines, hypertension is defined as systolic blood pressure level of more than ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg. Read more about this study

Who is it for?
Ages 20 to 55 years
Conditions the study is for
Hypertension
What is being tested?
Cycling 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
12 Jan 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

  • Medically diagnosed patients having Stage 1 hypertension(SBP;140-159 mmHg,DBP:90-99mmHg) and Stage 2 -hypertension(SBP:≥160mmHg,DBP:≥100mmHg) according to JNC 8 Guidelines, referred by a medical specialist or GP or cardiologist from FFH or clinical setups or Hospitals of Rawalpindi/Islambad
  • Patients who are on antihypertensive medications for at least 3 months before study.
  • Age ranging from 20-55 years
  • Both male and female patients.
  • Patients who are willing to participate in exercise regime and are able to -provide informed consent, have not been a part of any exercise regime from the last 6 months and well tolerated for exercise after being screened through PAR-Q+

Who cannot join

  • Patients with Stage 3 hypertension (SBP: ≥180 mmHg or DBP: ≥110 mmHg) and above hypertension according to JNC 8 Guidelines or Hypertensive Crisis etc.
  • Patients with any severe knee or other orthopedic conditions that can limit exercise performance
  • Patients with uncontrolled hypertension
  • History of any abdominal, orthopedic or spinal surgery that could interfere with core or breathing exercise
  • Neurological or psychiatric disorders
  • Uncontrolled cardiovascular conditions such as arrhythmias or recent myocardial infarction
  • Pregnant women

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saba Rehman, MSPT-CPT contact

03295200871

sabarehman278@gmail.com

Sana Bashir, PhD* contact

+923218529475

drsana.bashir@fui.edu.pk

Pakistan1 site, 1 recruiting
  • Foundation University, Islamabad

    Islamabad

    Sana Bashir, PhD*, +923218529475, drsana.bashir@fui.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Hypertension or high blood pressure is defined as when the pressure in the blood vessels is too high. According to Joint National Committee 8 (JNC 8) Guidelines, hypertension is defined as systolic blood pressure level of more than ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg. This study aims to study the combined effects of Pilates breathing, Diaphragmatic breathing and Moderate Intensity Continuous Cycling Training on blood pressure, chest expansion, pulmonary function and quality of life. Aerobic physical activity moderate intensity continuous training: (55%- 70% of maximal heart rate (MHR), rate of perceived exertion (RPE) of 11-13 on the Borg scale) continuous training, known as MICT. Pilates breathing exercise enhances lung expansion by focusing on controlled rhythmic breathing methods involving respiratory muscles. Diaphragmatic breathing exercise is slow and controlled deep breathing that has important effects on respiratory system by the modulation of autonomic nervous system. Hypertensive patients will be selected for this study. The study will include three groups. One group will undergo Cycling training with Pilates breathing and the other group will undergo Cycling training with Diaphragmatic breathing and third group will undergo Cycling training only. Before initiating the intervention at the baseline, following outcome measures would be assessed for all the patients: Blood pressure, chest expansion, pulmonary function and quality of life.

Read the detailed description

Hypertension or high blood pressure is defined as when the pressure in the blood vessels is too high. According to Joint National Committee 8 (JNC 8) Guidelines, hypertension is defined as systolic blood pressure level of more than ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg. Elevated blood pressure increases the heart's workload and it causes the heart to work harder and become stiffened and thick. High blood pressure can significantly impact a patient's quality of life. These impacts range from physical limitations and emotional distress to increased risk of severe health issues. Lifestyle modifications and exercise can help counteract its effects. This study aims to study the combined effects of Pilates breathing, Diaphragmatic breathing and Moderate Intensity Continuous Cycling Training on blood pressure, chest expansion, pulmonary function and quality of life. Three Parallel arm randomized control study consisting of three groups each group will contain 15 patients. Selection of subjects will be done by using non-probability purposive sampling technique.The sample size was calculated using G* power software version 3.1. This was determined for difference between two means (one-way ANOVA / Kruskal Wallis test), with significance level of 0.05 and power 0.95, which resulted in 45 participants to be enrolled in the study (15 in each group). Following tools will be used for assessment of outcome measures:

Sphygmomanometer (ICC = 0.91-0.97): To assess systolic and diastolic blood pressure.

Spirometry (ICC: 0.88-0.96): A diagnostic test used to assess lung function and help diagnose, monitor, and manage respiratory conditions. It measures the volume of air a person can inhale and exhale and how quickly they can do so. It measures FVC, FEV1 and FEV1/FVC ratio.

MINICHAL Questionnaire (ICC: 0.88,0.85): A useful and reliable instrument used to assess Quality of Life (QoL) in hypertensive patients. It is a short,16 question, self-administered questionnaire that explores both psychological and somatic aspects related to the impact of hypertension on a person's life.

Borg Scale (ICC: 0.7-0.9) It is a scale to measure rate of perceived exertion, a subjective method to measure the intensity of physical activity.The scale ranges from 6 to 20 with each number corresponding to subjective level of exertion Measuring Tape for Chest Expansion (ICC = 0.82-0.91): To measure chest expansion at xiphoid level Pulse Oximeter (ICC: 0.95): The pulse Oximeter is a non-invasive device, which provide digital readings: heart rate and oxygen saturation.

Participants will be selected according to non-probability purposive sampling technique and then randomly allocated to intervention group or control group through sealed envelope method. Single Blinded study (Participants will be kept blinded through sealed envelope method).A sealed envelope method will be used to ensure concealed allocation. Envelopes will be prepared in advance, shuffled thoroughly, and selected by the participants to determine group assignment.

This study involves 3 intervention groups naming:

GROUP A: Pilates Breathing+ Cycling GROUP B: Diaphragmatic Breathing + Cycling GROUP C: Cycling only. Following a total of 18 sessions over the course of 6 weeks period. Warm-up: Side bends, arm circles, torso twists, standing march. Cool-down: Quadriceps stretch, seated figure of four stretches, calf stretch.

Cycling Training (All Groups):

Protocol: Moderate-Intensity Continuous Training (MICT).

Parameters:

Frequency: 3 days/week Intensity: 60-79% of Maximum Heart Rate (HRmax), or Borg RPE 11-13. Progression: Based on structured Astrand-Rhyming cycle ergometer protocol guidelines.

Duration: As per the standard moderate-intensity cycling session duration (gradually increased if required).

Monitoring: Continuous heart rate and vitals monitoring throughout the cycling sessions.

Pilates breathing :

Focus: Lateral rib cage expansion, diaphragmatic control, core engagement. Position: Sitting or lying down.

Steps:

Neutral spine position. Hands placed on rib cage and abdomen. Inhale deeply expanding the ribs laterally.

Exhale drawing the navel inward to engage core muscles. Controlled breathing coordinated with warm-up and cool-down movements. Frequency: 3 days per week Intensity: Low intensity, the perceived effort should be 3-4/10 Time: 10-15 min/session Type: Lateral breathing exercises

Diaphragmatic breathing:

Focus: Deep abdominal breathing, enhancing diaphragmatic movement, autonomic balance.

Position: Supine or seated.

Steps:

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. Chest should remain still. Frequency: 3 days per week Intensity: Low intensity, the perceived effort should be 3-4/10 Time: 10-15 min/session Type: Seated or supine diaphragmatic breathing (inhale deeply through the nose, exhale slowly through pursed lips) to enhance lung function, reduce stress Data will be analyzed using SPSS v. 21.0.

Conditions
Hypertension
Being tested
Cycling Training (Moderate-intensity continuous training), Pilates Breathing, Diaphragmatic Breathing
Keywords
Hypertension, Pilates Breathing, Diaphragmatic Breathing, Cycling training, Pulmonary Function, Chest expansion, Quality of life
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cycling Training (Moderate-intensity continuous training)Other

    Moderate-intensity continuous cycling training performed at 60-79% 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. A 06 weeks protocol will be followed.

  • Diaphragmatic BreathingOther

    Slow deep breathing emphasizing diaphragmatic movement performed for 10-15 minutes.

    A 06 weeks protocol will be followed.

Study groups in NCT07529834
Study groupRoleWhat they receive
Cycling training with Pilates breathingExperimentalParticipants will perform moderate-intensity continuous cycling training with Pilates breathing exercise three times per week for six weeks.
Receives: Other: Pilates Breathing
Cycling training with diaphragmatic breathingExperimentalParticipants will perform moderate-intensity continuous cycling training combined with diaphragmatic breathing exercise three times per week for six weeks.
Receives: Other: Diaphragmatic Breathing
Cycling trainingActive comparatorParticipants will perform moderate-intensity continuous cycling training only, three times per week for six weeks.
Receives: Other: Cycling Training (Moderate-intensity continuous training)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure (SBP and DBP)

    Evaluation will be performed using a sphygmomanometer to measure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). Measurements will be recorded in millimeters of mercury (mmHg) under standardized conditions after at least 5 minutes of seated rest.

    Two readings will be taken, and the average value will be used for analysis

    Measured: 06 weeks

  2. Chest Expansion

    Evaluation will be performed by measuring chest expansion at the xiphoid level using a measuring tape. Chest circumference will be recorded in centimeters (cm) at maximum inspiration and maximum expiration, and chest expansion will be calculated as the difference between these two measurements.

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

    Measured: 06 weeks

  3. Pulmonary Function Test

    Evaluation will be performed using a spirometer device according to 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.

  1. First posted14 Apr 2026
  2. Study start12 Jan 2026
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 May 2026 (estimated)

Resources

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) wil perform Pilates breathing along with moderate-intensity continuous cycling training, and the second group (experimental group) will perform diaphragmatic breathing along with moderate-intensity continuous cycling training, and the third group (control group) will perform only moderate-intensity continuous cycling training
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07529834
Sponsor's protocol ID
FUCP/CTR/2026/03
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

Questions about this trial

What is this clinical trial studying?

A study testing Cycling Training (Moderate-intensity continuous training), Pilates Breathing and Diaphragmatic Breathing in people with 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 7 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 Saba Rehman, MSPT-CPT (03295200871, sabarehman278@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.

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