NCT06612099

Brief Summary

The research aims to compare two different exercise approaches applied to hypertensive individuals. After completion of the research, it will be revealed which exercise approach is more effective on the parameters evaluated in hypertensive individuals. In this context, it is aimed to increase the use of the exercise approach, which is found to be more effective in hypertensive individuals, in the treatment program.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
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

September 20, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

September 21, 2024

Last Update Submit

September 28, 2024

Conditions

Hypertension

Keywords

Hypertensive DiseaseAerobic exerciseMat Pilates ExerciseHypertensionBlood PressureFunctional capacityQuality of life (QOL)Physiotherapy and rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Blood Pressure

    During the measurement, the patient should not be talking, should be leaning back, sitting on a chair, without crossing his legs, without crossing his feet, with his feet touching the ground, with his arm supported at heart level, and after resting calmly for at least 5 minutes. After the brachial artery is palpated in the arm, the cuff is placed 2-3 cm below the antecubital fossa. After inflating sufficiently, the pressure will be reduced and the measurement value will be recorded after carefully listening to the beginning and end of the Korotkoff sounds.

    2 months

  • Functional Capacity

    6 Minute Walk Test will be used to evaluate the submaximal functional capacity of the patients. The aim of this test is to walk the longest distance possible in a 30 meter long corridor within 6 minutes. The testing will be performed in accordance with the guidelines reported by the American Thoracic Society.

    2 months

Secondary Outcomes (1)

  • Quality of life

    2 months

Study Arms (3)

Aerobic Exercise Group

EXPERIMENTAL

Individuals in this group will perform aerobic exercise training on a treadmill/bicycle under the supervision of a physiotherapist for a period of 8 weeks, consisting of a total of 24 training sessions. Moderate intensity aerobic exercise training will be set by calculating the target heart rate range. During the training session, individuals will receive a total of 50 minutes of training, consisting of a 10-minute warm-up, 30 minutes of moderate walking/cycling and a 10-minute cool-down period. In addition to the aerobic exercise training group, on the days he does not come to the session, resistance exercises will be taught in the form of 2 sets of 8 repetitions, with weights of 60-80% of 1 maximum repetition, according to the guidelines of the American Sports Medicine Association, and will be given as home exercises.

Other: Aerobic Exercise

Mat Pilates Exercise Group

ACTIVE COMPARATOR

Individuals in this group will perform mat pilates exercises under the supervision of a physiotherapist for a period of 8 weeks, consisting of a total of 24 exercise sessions. During the exercise sessions, individuals will undergo a 50-minute mat pilates exercise program. In addition to the mat pilates exercise group, on the days when he does not come to the session, resistance exercises will be taught in the form of 2 sets of 8 repetitions, 60-80% of 1 maximum repetition, according to the guidelines of the American Sports Medicine Association, and will be given as home exercises.

Other: Mat Pilates Exercise

Control Group

NO INTERVENTION

Hypertensive individuals who meet the inclusion and exclusion criteria will note their blood pressure values 2 days a week for 8 weeks and share them with the physiotherapist. Patients in this group will be instructed to continue their normal lives.

Interventions

Aerobic ExerciseOTHER

Individuals in this group will perform aerobic exercise training on a treadmill/bicycle under the supervision of a physiotherapist for a period of 8 weeks, consisting of a total of 24 training sessions. Moderate intensity aerobic exercise training will be set by calculating the target heart rate range. During the training session, individuals will receive a total of 50 minutes of training, consisting of a 10-minute warm-up, 30 minutes of moderate walking/cycling and a 10-minute cool-down period. In addition to the aerobic exercise training group, on the days he does not come to the session, resistance exercises will be taught in the form of 2 sets of 8 repetitions, with weights of 60-80% of 1 maximum repetition, according to the guidelines of the American Sports Medicine Association, and will be given as home exercises.

Aerobic Exercise Group
Mat Pilates ExerciseOTHER

Individuals in this group will perform mat pilates exercises under the supervision of a physiotherapist for a period of 8 weeks, consisting of a total of 24 exercise sessions. During the exercise sessions, individuals will undergo a 50-minute mat pilates exercise program. In addition to the mat pilates exercise group, on the days when he does not come to the session, resistance exercises will be taught in the form of 2 sets of 8 repetitions, 60-80% of 1 maximum repetition, according to the guidelines of the American Sports Medicine Association, and will be given as home exercises.

Mat Pilates Exercise Group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension (blood pressure ≥ Individuals diagnosed with 85/135 mmHg) and under medical follow-up,
  • Volunteering to participate in the study,
  • Not having been included in any exercise program in the last 4 weeks.

You may not qualify if:

  • Blood pressure Individuals with ≥ 110/180 mmHg,
  • Having had a cerebrovascular accident or cardiovascular disease in the last 6 months,
  • Having an orthopedic or neurological disorder that prevents walking.
  • Having serious cardiovascular/pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyüp, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Saco-Ledo G, Valenzuela PL, Ruiz-Hurtado G, Ruilope LM, Lucia A. Exercise Reduces Ambulatory Blood Pressure in Patients With Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2020 Dec 15;9(24):e018487. doi: 10.1161/JAHA.120.018487. Epub 2020 Dec 5.

    PMID: 33280503BACKGROUND

  • Ramirez-Jimenez M, Morales-Palomo F, Moreno-Cabanas A, Alvarez-Jimenez L, Ortega JF, Mora-Rodriguez R. Aerobic exercise training improves nocturnal blood pressure dipping in medicated hypertensive individuals. Blood Press Monit. 2022 Aug 1;27(4):272-275. doi: 10.1097/MBP.0000000000000598. Epub 2022 Apr 18.

    PMID: 35438082BACKGROUND

  • Caminiti G, Iellamo F, Mancuso A, Cerrito A, Montano M, Manzi V, Volterrani M. Effects of 12 weeks of aerobic versus combined aerobic plus resistance exercise training on short-term blood pressure variability in patients with hypertension. J Appl Physiol (1985). 2021 Apr 1;130(4):1085-1092. doi: 10.1152/japplphysiol.00910.2020. Epub 2021 Feb 25.

    PMID: 33630677BACKGROUND

  • Carlin de Ramos do Espirito Santo B, Amante Cardoso L, Sudatti Delevatti R, de la Rocha Freitas C. +Acute blood pressure response after Mat Pilates alone and combined with aerobic exercise. J Bodyw Mov Ther. 2024 Jul;39:579-582. doi: 10.1016/j.jbmt.2024.03.010. Epub 2024 Mar 17.

    PMID: 38876689BACKGROUND

  • Martins-Meneses DT, Antunes HK, de Oliveira NR, Medeiros A. Mat Pilates training reduced clinical and ambulatory blood pressure in hypertensive women using antihypertensive medications. Int J Cardiol. 2015 Jan 20;179:262-8. doi: 10.1016/j.ijcard.2014.11.064. Epub 2014 Nov 6.

    PMID: 25464462BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Çağla Yılmaz, BPT

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

  • Alis Kostanoğlu, PhD

    Bezmialem Vakif University

    STUDY DIRECTOR

  • Ahmet Bacaksız, PhD

    Bezmialem Vakif University

    STUDY CHAIR

Central Study Contacts

Çağla Yılmaz, BPT

CONTACT

5370101901caglayillllmaz@gmail.com

Alis Kostanoğlu, PhD

CONTACT

aliskostanoglu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2024

First Posted

September 25, 2024

Study Start

September 20, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

October 1, 2024

Record last verified: 2024-09

Locations

TU(1)