- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433790
Mat Pilates With Paced Breathing Versus Diaphragmatic Breathing in Stage II Hypertension
Effects of Paced Breathing Versus Diaphragmatic Breathing Combined With Mat Pilates on Cardiopulmonary Endurance, Dyspnea, Stress, Anxiety, and Quality of Life in Patients With Stage II Hypertension: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial conducted at the Physiotherapy Department of the University of Lahore Teaching Hospital, Lahore. A total of 63 hypertensive patients will be screened from the Outpatient Department (OPD) after clinical diagnosis by a qualified medical specialist.
Eligible participants who meet inclusion criteria and provide written informed consent will be enrolled using a non-probability purposive sampling technique. Participants will be randomly allocated into two parallel groups using a sealed envelope method to ensure allocation concealment.
Participants in:
Group A:
Will receive mat Pilates exercises combined with paced breathing training.
Group B:
Will receive mat Pilates exercises combined with diaphragmatic breathing training.
Both groups will undergo supervised intervention sessions three times per week on alternate days for a total duration of six weeks. Each session will last approximately 45-60 minutes.
Outcome measures will be assessed at baseline and at the end of the six-week intervention period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- University of Lahore Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 40 to 50 years
- Clinically diagnosed Stage II hypertension confirmed by a qualified healthcare provider
- On a stable antihypertensive medication regimen for at least 4 weeks
- Moderate dyspnea levels as measured by the Modified Borg Dyspnea Scale
- Not currently participating in any structured exercise or rehabilitation program
- Able to understand instructions and complete questionnaires
- Willing to provide written informed consent
Exclusion Criteria:
- Uncontrolled hypertension (e.g., blood pressure greater than 180/110 mmHg)
- History of recent cardiovascular events (e.g., myocardial infarction within the past 6 months)
- Severe neurological or musculoskeletal disorders limiting mobility
- Severe anxiety or stress requiring psychiatric intervention
- Severe cognitive impairment or communication barriers
- Currently enrolled in another clinical trial or structured wellness program
- Any medical contraindication to physical activity as advised by a physician
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: Mat Pilates + Paced Breathing
Participants assigned to this arm will receive a supervised mat Pilates program combined with paced breathing exercises, performed three times per week on alternate days for six weeks.
Each session will last approximately 45-60 minutes.
|
Participants will perform paced breathing exercises using a controlled respiratory rate guided by therapist instruction during sessions.
Paced breathing will be integrated with mat Pilates sessions, three times per week for six weeks.
|
|
Experimental: Mat Pilates + Diaphragmatic Breathing
Participants assigned to this arm will receive a supervised mat Pilates program combined with diaphragmatic breathing exercises, performed three times per week on alternate days for six weeks.
Each session will last approximately 45-60 minutes.
|
Standardized mat-based Pilates exercises focusing on breathing control, core stability, postural alignment, flexibility, and strengthening.
Sessions will be supervised and conducted three times per week on alternate days for six weeks, with each session lasting approximately 45-60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress and Anxiety Levels (DASS-21)
Time Frame: Baseline and at 6 weeks
|
Stress and anxiety levels will be assessed using the Depression Anxiety Stress Scale - 21 items (DASS-21).
Each subscale consists of 7 items scored on a 4-point Likert scale (0 = Did not apply to me at all to 3 = Applied to me very much or most of the time).
Scores are multiplied by 2 to calculate final subscale scores.
Higher scores indicate greater psychological distress.
|
Baseline and at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiopulmonary Endurance (6-Minute Walk Test)
Time Frame: Baseline and at 6 weeks
|
Cardiopulmonary endurance will be measured using the 6-Minute Walk Test (6MWT).
The total distance walked in meters over six minutes will be recorded.
Higher distance indicates improved cardiopulmonary endurance.
|
Baseline and at 6 weeks
|
|
Dyspnea Severity (Modified Borg Dyspnea Scale)
Time Frame: Baseline and at 6 weeks
|
Dyspnea will be assessed using the Modified Borg Dyspnea Scale, a numerical rating scale ranging from 0 (no breathlessness) to 10 (maximal breathlessness).
Higher scores indicate more severe dyspnea.
|
Baseline and at 6 weeks
|
|
Health-Related Quality of Life (SF-12)
Time Frame: Baseline and at 6 weeks
|
Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12), which evaluates physical and mental health domains.
Higher scores indicate better perceived health status.
|
Baseline and at 6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Batista, J. P., Tavares, J. B., Goncalves, L. F., de Souza, T. C. F., Mariano, I. M., Amaral, A. L., Rodrigues, M. d. L., Matias, L. A. S., Magalhaes Resende, A. P., & Puga, G. M. (2022). Mat Pilates training reduces blood pressure in both well-controlled hypertensive and normotensive postmenopausal women: a controlled clinical trial study. Clinical and Experimental Hypertension, 44(6), 548-556.
- Bartolain, T. (2024). Short-Term Pilates Exercise Intervention and Its Impact on Functional Movement in Healthy Middle-Aged Adults.
- Balban, M. Y., Neri, E., Kogon, M. M., Weed, L., Nouriani, B., Jo, B., Holl, G., Zeitzer, J. M., Spiegel, D., & Huberman, A. D. (2023). Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Reports Medicine, 4(1).
- BAKIR, N., VURAL, P. I., & DEMİR, C. (2024). The Effects of Diaphragmatic Breathing Exercise on Hot Flashes in Menopausal Women during the COVID-19 Pandemic Period: A Randomized Controlled Trial. Gümüshane Üniversitesi Saglik Bilimleri Dergisi, 13(3).
- Amaral, A. L., Batista, J., Goncalves, L., Tavares, J., Souza, T. C., Mariano, I., Rodrigues, M., Junior, J. C., Araujo, K., & Ribeiro, P. (2021). EFFECTS OF MAT PILATES TRAINING ON BODY COMPOSITION AND CARDIOMETABOLIC MARKERS IN POSTMENOPAUSAL WOMEN WITH MULTIMORBIDITY. Journal of hypertension, 39, e416-e417.
- Almeida, I. d. S., Andrade, L. d. S., Sousa, A. M. M. d., Junior, G. C., Catai, A. M., Mota, Y. L., & Durigan, J. L. Q. (2022). Is the combination of aerobic exercise with Mat Pilates better than Mat Pilates training alone on autonomic modulation related to functional outcomes in hypertensive women? Secondary analysis of a randomized controlled trial. International Journal of Environmental Research and Public Health, 19(17), 10577.
- Akpama, T. G. (2024). Study on the influence of socioeconomic factors on hypertension prevalence.
- Adawiyah, R., & Sinaga, W. (2024). HUBUNGAN GENETIK DAN USIA DENGAN PENYAKIT HIPERTENSI DI PUSKESMAS PASAR MINGGU JAKARTA SELATAN. Mayapada Nursing Journal, 1(1), 15-20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- UOL/IREB/25/12/0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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