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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Foundation University Islamabad · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
OTHER	Cycling Training (Moderate-intensity continuous training)	Moderate-intensity continuous cycling training performed at 60-79% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.
OTHER	Pilates Breathing	Controlled lateral breathing technique focusing on rib cage expansion and core activation performed for 10-15 minutes. A 06 weeks protocol will be followed.
OTHER	Diaphragmatic Breathing	Slow deep breathing emphasizing diaphragmatic movement performed for 10-15 minutes. A 06 weeks protocol will be followed.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Pakistan