PrehypertensionNCT06762262
Effects of Pilate Training Versus Moderate Intensity Continous Training in Hypertensive Patients
A study testing Moderate-Intensity continuous training in people with Prehypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
Hypertension, commonly known as high blood pressure, continues to be the leading cause of both sickness and mortality globally. Generally, individuals in good health might have trouble breathing solely during vigorous exercise or when holding their breath, finding relief by stopping the activity or adjusting their… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Prehypertension
- What is being tested?
- Moderate-Intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be between 45 to 70 years old
- Gender: Male and Female both
- Chronic, mild-to moderate, and stable (>1 year duration) hypertension (systolic blood pressure
- [SBP] between 140-179 mm Hg and diastolic blood pressure [DBP] between 90-109 mm Hg).
- Single antihypertensive medication will be recruited.
- Participants have sedentary life style.
- Smokers, alcoholic, diabetic, and other cardiac problems (controlled) would be included.
Who cannot join
- Patients with Permanent atrial fibrillation
- Patients with COPD
- Patients with Heart surgery
- Patients with presence of symptomatic congestive heart failure
- Smokers, alcoholic, diabetic, and other cardiac, renal, and respiratory disease patients (uncontrolled) would be excluded.
- Participants with no history of psychiatry or psychological disorders or abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pilate Training Versus Moderate Intensity Continous Training on Dyspnea and Cardiovascular Fitness in Hypertensive Patients
Hypertension, commonly known as high blood pressure, continues to be the leading cause of both sickness and mortality globally. Generally, individuals in good health might have trouble breathing solely during vigorous exercise or when holding their breath, finding relief by stopping the activity or adjusting their breathing technique. Often patients with hypertension seek various treatments to relieve symptoms. The aim of this study is to compare the effects of Pilates Training and Moderate Intensity Continuous Training on dyspnea and cardiovascular fitness in hypertensive patients. The study would be randomized clinical trial. A total of thirty-four subjects will be assigned randomly by using block randomization into two groups. Group A will be given Pilates training while Group B will moderate intensity training. After confirmation of diagnosis with medical history and physical examination as well as chronic, mild-to moderate, and stable (>1 year duration) hypertension (systolic blood pressure [SBP] between 140-179 mm Hg and diastolic blood pressure [DBP]between 90-109 mm Hg) recommended. 3-minute step test, VO2max and Modified BORG scale would be used as an outcome measure tools for cardiovascular parameters and dyspnea. The collected data will be analyzed in SPSS 25.0. Descriptive and inferential statistics will be applied after testing normality of data
- Conditions
- Prehypertension
- Being tested
- Moderate-Intensity continuous training
- Keywords
- Hypertension, Dyspnea, Pilates Training, Modified-Intensity Training
- Medical subject headings
- Prehypertension, Hypertension, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity continuous trainingCombination product
refers to a type of aerobic exercise that involves maintaining a steady and moderate level of physical activity for an extended period. The exercise is performed at a consistent and moderate pace without significant fluctuations in intensity. MICT primarily targets the aerobic energy system, enhancing cardiovascular endurance and respiratory efficiency
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Moderate-Intensity continuous training (MICT) refers to a type of aerobic exercise that involves maintaining a steady and moderate level of physical activity for an extended period. The exercise is performed at a consistent and moderate pace without significant fluctuations in intensity. MICT primarily targets the aerobic energy system, enhancing cardiovascular endurance and respiratory efficiency Receives: Combination Product: Moderate-Intensity continuous training |
| Controlled | Other | Will receive Pilates exercises, Mild stretching, Glute Bridge, Isometric Glute Bridge, Single Leg Raise, Upper Abdominal Curl, Single- leg Strech, Double-Leg Strech, Plank Push Backs, roll down, Cool down. Pilates exercises emphasize controlled movements, proper breathing, and the engagement of the deep core muscles. Pilates exercises can be performed on a mat or using specialized equipment such as a reformer. Receives: Combination Product: Moderate-Intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 MWT
Measured: 8 weeks
VO2 max
Measured: 8 weeks
Borg Dyspnea Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Apr 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera Nassser, Mphill, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762262
- Sponsor's protocol ID
- Rabbia Naseer Ahmed
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilate Training Versus Moderate Intensity Continous Training on Dyspnea and Cardiovascular Fitness in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06762262
- Acronym / sponsor ID
- Rabbia Naseer Ahmed
- Conditions
- Prehypertension
- Keywords
- Hypertension, Dyspnea, Pilates Training, Modified-Intensity Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
Hypertension, commonly known as high blood pressure, continues to be the leading cause of both sickness and mortality globally. Generally, individuals in good health might have trouble breathing solely during vigorous exercise or when holding their breath, finding relief by stopping the activity or adjusting their breathing technique. Often patients with hypertension seek various treatments to relieve symptoms. The aim of this study is to compare the effects of Pilates Training and Moderate Intensity Continuous Training on dyspnea and cardiovascular fitness in hypertensive patients. The study would be randomized clinical trial. A total of thirty-four subjects will be assigned randomly by using block randomization into two groups. Group A will be given Pilates training while Group B will moderate intensity training. After confirmation of diagnosis with medical history and physical examination as well as chronic, mild-to moderate, and stable (>1 year duration) hypertension (systolic blood pressure [SBP] between 140-179 mm Hg and diastolic blood pressure [DBP]between 90-109 mm Hg) recommended. 3-minute step test, VO2max and Modified BORG scale would be used as an outcome measure tools for cardiovascular parameters and dyspnea. The collected data will be analyzed in SPSS 25.0. Descriptive and inferential statistics will be applied after testing normality of data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Combination Product: Moderate-Intensity continuous trainingModerate-Intensity continuous training (MICT) refers to a type of aerobic exercise that involves maintaining a steady and moderate level of physical activity for an extended period. The exercise is performed at a consistent and moderate pace without significant fluctuations in intensity. MICT primarily targets the aerobic energy system, enhancing cardiovascular endurance and respiratory efficiency |
| Controlled | Other | Combination Product: Moderate-Intensity continuous trainingWill receive Pilates exercises, Mild stretching, Glute Bridge, Isometric Glute Bridge, Single Leg Raise, Upper Abdominal Curl, Single- leg Strech, Double-Leg Strech, Plank Push Backs, roll down, Cool down. Pilates exercises emphasize controlled movements, proper breathing, and the engagement of the deep core muscles. Pilates exercises can be performed on a mat or using specialized equipment such as a reformer. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be between 45 to 70 years old
- Gender: Male and Female both
- Chronic, mild-to moderate, and stable (>1 year duration) hypertension (systolic blood pressure
- [SBP] between 140-179 mm Hg and diastolic blood pressure [DBP] between 90-109 mm Hg).
- Single antihypertensive medication will be recruited.
Key exclusion criteria (6 listed)
- Patients with Permanent atrial fibrillation
- Patients with COPD
- Patients with Heart surgery
- Patients with presence of symptomatic congestive heart failure
- Smokers, alcoholic, diabetic, and other cardiac, renal, and respiratory disease patients (uncontrolled) would be excluded.
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 |
|---|---|---|
| Moderate-Intensity continuous trainingrefers to a type of aerobic exercise that involves maintaining a steady and moderate level of physical activity for an extended period. The exercise is performed at a consistent and moderate pace without significant fluctuations in intensity. MICT primarily targets the aerobic energy system, enhancing cardiovascular endurance and respiratory efficiency | Combination product | Controlled, Treatment Group |
Primary outcome
6 MWT
Time frame: 8 weeks
VO2 max
Time frame: 8 weeks
Borg Dyspnea Scale
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Sumera Nassser, Mphill study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity continuous training in people with Prehypertension, run by Riphah International University 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 6 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
6 MWT (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.