- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529834
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saba Rehman, MSPT-CPT
- Phone Number: 03295200871
- Email: sabarehman278@gmail.com
Study Contact Backup
- Name: Sana Bashir, PhD*
- Phone Number: +923218529475
- Email: drsana.bashir@fui.edu.pk
Study Locations
-
-
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Islamabad, Pakistan
- Recruiting
- Foundation University, Islamabad
-
Contact:
- Sana Bashir, PhD*
- Phone Number: +923218529475
- Email: drsana.bashir@fui.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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+
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cycling training with Pilates breathing
Participants will perform moderate-intensity continuous cycling training with Pilates breathing exercise three times per week for six weeks.
|
Controlled lateral breathing technique focusing on rib cage expansion and core activation performed for 10-15 minutes.
A 06 weeks protocol will be followed.
|
|
Experimental: Cycling training with diaphragmatic breathing
Participants will perform moderate-intensity continuous cycling training combined with diaphragmatic breathing exercise three times per week for six weeks.
|
Slow deep breathing emphasizing diaphragmatic movement performed for 10-15 minutes. A 06 weeks protocol will be followed. |
|
Active Comparator: Cycling training
Participants will perform moderate-intensity continuous cycling training only, three times per week for six weeks.
|
Moderate-intensity continuous cycling training performed at 60-79% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure (SBP and DBP)
Time Frame: 06 weeks
|
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 |
06 weeks
|
|
Chest Expansion
Time Frame: 06 weeks
|
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. |
06 weeks
|
|
Pulmonary Function Test
Time Frame: 06 weeks
|
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. |
06 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUCP/CTR/2026/03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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