Effects of Pilate Training Versus Moderate Intensity Continous Training in Hypertensive Patients

January 1, 2025 updated by: Riphah International University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Balochistan
      • Quetta, Balochistan, Pakistan, oooo
        • Sheikh Zaid Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
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
Combination product: Moderate-Intensity continuous training
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
Other: Controlled
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.
Combination product: Moderate-Intensity continuous training
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
6 MWT
Time Frame: 8 weeks
8 weeks
VO2 max
Time Frame: 8 weeks
8 weeks
Borg Dyspnea Scale
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sumera Nassser, Mphill, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rabbia Naseer Ahmed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings