HypertensionNCT07433790
Mat Pilates With Paced Breathing Versus Diaphragmatic Breathing in Stage II Hypertension
A study testing Mat Pilates and Paced Breathing in people with Hypertension and Stage II Hypertension, run by University of Lahore at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effects of mat Pilates combined with paced breathing versus mat Pilates combined with diaphragmatic breathing on stress, anxiety, cardiopulmonary endurance, dyspnea, and quality of life in patients with Stage II hypertension. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Hypertension, Stage II Hypertension, Essential Hypertension
- What is being tested?
- Mat Pilates and Paced Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2025to 18 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province
About this study
Official title: 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
This randomized controlled trial aims to compare the effects of mat Pilates combined with paced breathing versus mat Pilates combined with diaphragmatic breathing on stress, anxiety, cardiopulmonary endurance, dyspnea, and quality of life in patients with Stage II hypertension. Participants will be recruited from the Physiotherapy Department of the University of Lahore Teaching Hospital. Outcome measures will include DASS-21, 6-Minute Walk Test (6MWT), Modified Borg Dyspnea Scale, and SF-12 Health Survey. The intervention will be conducted three times per week for six weeks.
Read the 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.
- Conditions
- Hypertension, Stage II Hypertension, Essential Hypertension
- Being tested
- Mat Pilates, Paced Breathing
- Keywords
- Mat Pilates, Paced Breathing, Diaphragmatic Breathing, Breathing Exercises, Cardiopulmonary Endurance, 6-Minute Walk Test
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat PilatesOther
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.
Paced BreathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mat Pilates + Paced Breathing | Experimental | 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. Receives: Behavioral: Paced Breathing |
| Mat Pilates + Diaphragmatic Breathing | Experimental | 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. Receives: Other: Mat Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress and Anxiety Levels (DASS-21)
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.
Measured: Baseline and at 6 weeks
Secondary outcomes (3)
Cardiopulmonary Endurance (6-Minute Walk Test)
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.
Measured: Baseline and at 6 weeks
Dyspnea Severity (Modified Borg Dyspnea Scale)
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.
Measured: Baseline and at 6 weeks
Health-Related Quality of Life (SF-12)
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.
Measured: Baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 Sep 2025
- Primary completion15 Oct 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Participants will be randomly assigned into two parallel groups to receive either mat Pilates combined with paced breathing or mat Pilates combined with diaphragmatic breathing for six weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amina Shahzadi, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433790
- Sponsor's protocol ID
- UOL/IREB/25/12/0004
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This study is being conducted as an academic research project. The informed consent obtained from participants does not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
Publications
Batista JP, Tavares JB, Goncalves LF, de Souza TCF, Mariano IM, Amaral AL, Rodrigues ML, Matias LAS, Magalhaes Resende AP, Puga GM. Mat Pilates training reduces blood pressure in both well-controlled hypertensive and normotensive postmenopausal women: a controlled clinical trial study. Clin Exp Hypertens. 2022 Aug 18;44(6):548-556. doi: 10.1080/10641963.2022.2079670. Epub 2022 Jun 1.
PubMed 35642490Bartolain, T. (2024). Short-Term Pilates Exercise Intervention and Its Impact on Functional Movement in Healthy Middle-Aged Adults.
Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.
PubMed 36630953BAKIR, 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 IDS, Andrade LS, Sousa AMM, Junior GC, Catai AM, Mota YL, Durigan JLQ. 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. Int J Environ Res Public Health. 2022 Aug 25;19(17):10577. doi: 10.3390/ijerph191710577.
PubMed 36078292Akpama, 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 at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07433790
- Acronym / sponsor ID
- UOL/IREB/25/12/0004
- Conditions
- Hypertension, Stage II Hypertension, Essential Hypertension
- Keywords
- Mat Pilates, Paced Breathing, Diaphragmatic Breathing, Breathing Exercises, Cardiopulmonary Endurance, 6-Minute Walk Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare the effects of mat Pilates combined with paced breathing versus mat Pilates combined with diaphragmatic breathing on stress, anxiety, cardiopulmonary endurance, dyspnea, and quality of life in patients with Stage II hypertension. Participants will be recruited from the Physiotherapy Department of the University of Lahore Teaching Hospital. Outcome measures will include DASS-21, 6-Minute Walk Test (6MWT), Modified Borg Dyspnea Scale, and SF-12 Health Survey. The intervention will be conducted three times per week for six weeks.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups to receive either mat Pilates combined with paced breathing or mat Pilates combined with diaphragmatic breathing for six weeks.
| Arm | Type | Receives |
|---|---|---|
| Mat Pilates + Paced Breathing | Experimental | Behavioral: Paced BreathingParticipants 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. |
| Mat Pilates + Diaphragmatic Breathing | Experimental | Other: Mat PilatesParticipants 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. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mat PilatesStandardized 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. | Other | Mat Pilates + Diaphragmatic Breathing |
| Paced BreathingParticipants 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. | Behavioural | Mat Pilates + Paced Breathing |
Primary outcome
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.
3 secondary outcomes
Cardiopulmonary Endurance (6-Minute Walk Test)
Time frame: Baseline and at 6 weeks
Dyspnea Severity (Modified Borg Dyspnea Scale)
Time frame: Baseline and at 6 weeks
Health-Related Quality of Life (SF-12)
Time frame: Baseline and at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 35642490Batista JP, Tavares JB, Goncalves LF, de Souza TCF, Mariano IM, Amaral AL, Rodrigues ML, Matias LAS, Magalhaes Resende AP, Puga GM. Mat Pilates training reduces blood pressure in both well-controlled hypertensive and normotensive postmenopausal women: a controlled clinical trial study. Clin Exp Hypertens. 2022 Aug 18;44(6):548-556. doi: 10.1080/10641963.2022.2079670. Epub 2022 Jun 1.
- BackgroundBartolain, T. (2024). Short-Term Pilates Exercise Intervention and Its Impact on Functional Movement in Healthy Middle-Aged Adults.
- Background: PubMed 36630953Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.
- BackgroundBAKIR, 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).
- BackgroundAmaral, 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.
- Background: PubMed 36078292Almeida IDS, Andrade LS, Sousa AMM, Junior GC, Catai AM, Mota YL, Durigan JLQ. 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. Int J Environ Res Public Health. 2022 Aug 25;19(17):10577. doi: 10.3390/ijerph191710577.
- BackgroundAkpama, T. G. (2024). Study on the influence of socioeconomic factors on hypertension prevalence.
- BackgroundAdawiyah, R., & Sinaga, W. (2024). HUBUNGAN GENETIK DAN USIA DENGAN PENYAKIT HIPERTENSI DI PUSKESMAS PASAR MINGGU JAKARTA SELATAN. Mayapada Nursing Journal, 1(1), 15-20.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This study is being conducted as an academic research project. The informed consent obtained from participants does not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mat Pilates and Paced Breathing in people with Hypertension and Stage II Hypertension, run by University of Lahore 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 7 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: finished, as of the sponsor's last update on 25 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress and Anxiety Levels (DASS-21) (time frame: Baseline and at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433790, which also lists 8 linked publications.
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 25 Feb 2026.