NCT07529834

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jan 2026May 2026

Study Start

First participant enrolled

January 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 27, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

HypertensionPilates BreathingDiaphragmatic BreathingCycling trainingPulmonary FunctionChest expansionQuality of life

Outcome Measures

Primary Outcomes (3)

  • 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

    06 weeks

  • 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.

    06 weeks

  • 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.

    06 weeks

Study Arms (3)

Cycling training with Pilates breathing

EXPERIMENTAL

Participants will perform moderate-intensity continuous cycling training with Pilates breathing exercise three times per week for six weeks.

Other: Pilates Breathing

Cycling training with diaphragmatic breathing

EXPERIMENTAL

Participants will perform moderate-intensity continuous cycling training combined with diaphragmatic breathing exercise three times per week for six weeks.

Other: Diaphragmatic Breathing

Cycling training

ACTIVE COMPARATOR

Participants will perform moderate-intensity continuous cycling training only, three times per week for six weeks.

Other: Cycling Training (Moderate-intensity continuous training)

Interventions

Controlled lateral breathing technique focusing on rib cage expansion and core activation performed for 10-15 minutes. A 06 weeks protocol will be followed.

Cycling training with Pilates breathing

Slow deep breathing emphasizing diaphragmatic movement performed for 10-15 minutes. A 06 weeks protocol will be followed.

Cycling training with diaphragmatic breathing

Moderate-intensity continuous cycling training performed at 60-79% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.

Cycling training

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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+

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University, Islamabad

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Saba Rehman, MSPT-CPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the allocation of intervention groups. Rndomization will be performed using sealed envelop method to ensure allocation concealment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 14, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

April 14, 2026

Record last verified: 2026-03

Locations