NCT06762262

Brief 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 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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 1, 2025

Last Update Submit

January 1, 2025

Conditions

Keywords

Hypertension, Dyspnea, Pilates Training, Modified-Intensity Training

Outcome Measures

Primary Outcomes (3)

  • 6 MWT

    8 weeks

  • VO2 max

    8 weeks

  • Borg Dyspnea Scale

    8 weeks

Study Arms (2)

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

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.

Combination Product: Moderate-Intensity continuous training

Interventions

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

ControlledTreatment Group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zaid Hospital

Quetta, Balochistan, oooo, Pakistan

Location

MeSH Terms

Conditions

PrehypertensionHypertensionDyspnea

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sumera Nassser, Mphill

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

April 20, 2024

Primary Completion

December 30, 2024

Study Completion

April 30, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations