HypertensionNCT06612099
Comparison of the Effects of Aerobic Exercise Training and Mat Pilates Exercise on Blood Pressure, Functional Capacity and Quality of Life in Hypertensive Individuals
A study testing Aerobic Exercise and Mat Pilates Exercise in people with Hypertension, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic Exercise and Mat Pilates Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2024to 30 May 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Alis Kostanoğlu, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Eyüp, 34000
Çağla Yılmaz, BPT, 5370101901 ext. +90, caglayillllmaz@gmail.com
Alis Kostanoğlu, PhD, aliskostanoglu@gmail.com
About this study
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.
Read the detailed description
Exercise is an important lifestyle change in treating and controlling hypertension. The International Society of Hypertension recommends increasing physical activity in the long term as a lifestyle intervention to improve blood pressure control and reduce the risk of cardiovascular disease in hypertensive individuals. Regular exercise appears to reduce drug use as part of lifestyle change in the treatment of hypertension. The risk of developing hypertension in individuals with a sedentary lifestyle is higher than in individuals who engage in regular physical activity.
In addition, new exercise programs such as mat pilates exercises are also applied to hypertensive individuals. Mat pilates exercises are a resistance exercise method used worldwide, especially for middle-aged individuals who do not engage in regular physical activity. In addition, Mat pilates exercises have promising effects, reducing short-term systolic blood pressure by 7.4 mmHg and long-term resting systolic blood pressure by 5.8-7.6 mmHg and diastolic blood pressure by 3.3-3.6 mmHg. These data require further research on the use of mat pilates exercises in hypertensive individuals.
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.
- Conditions
- Hypertension
- Being tested
- Aerobic Exercise, Mat Pilates Exercise
- Keywords
- Hypertensive Disease, Aerobic exercise, Mat Pilates Exercise, Hypertension, Blood Pressure, Functional capacity, Quality of life (QOL), Physiotherapy and rehabilitation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
Quality of life
The EQ-5D-5L general quality of life scale was developed by the EuroQol group, the Western European Quality of Life Research Society, in 1987 and consists of two parts. The first part is the health profile of that day; It allows it to be defined in five sub-dimensions: movement, self-care, usual activities, pain / discomfort and anxiety / depression. Answers given in each section; It has 5 options: "no problem", "mild problem", "moderate problem", "severe problem" and "extreme problem". The second part consists of the visual analog scale (VAS). In this section, individuals give values between 0 and 100 about their current health status and mark this on a thermometer-like scale. Quality of life scores ranging from 0 to 100 are obtained from the visual analog scale section. As the score of the scale increases, the perception of health increases positively. The Turkish version of the scale, which has been translated into 171 languages by the EuroQol group, will be used in the study.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start20 Sep 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla Yılmaz, Bezmialem Vakif University
- Investigators
- Çağla Yılmaz, BPT, Principal investigator, Bezmialem Vakif UniversityAlis Kostanoğlu, PhD, Study director, Bezmialem Vakif UniversityAhmet Bacaksız, PhD, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612099
- Sponsor's protocol ID
- 21/09/2024-155794
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33280503Ramirez-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.
PubMed 35438082Caminiti 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.
PubMed 33630677Carlin 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.
PubMed 38876689Martins-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.
PubMed 25464462
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Aerobic Exercise Training and Mat Pilates Exercise on Blood Pressure, Functional Capacity and Quality of Life in Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT06612099
- Acronym / sponsor ID
- 21/09/2024-155794
- Conditions
- Hypertension
- Keywords
- Hypertensive Disease, Aerobic exercise, Mat Pilates Exercise, Hypertension, Blood Pressure, Functional capacity, Quality of life (QOL), Physiotherapy and rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
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.
Detailed description
Exercise is an important lifestyle change in treating and controlling hypertension. The International Society of Hypertension recommends increasing physical activity in the long term as a lifestyle intervention to improve blood pressure control and reduce the risk of cardiovascular disease in hypertensive individuals. Regular exercise appears to reduce drug use as part of lifestyle change in the treatment of hypertension. The risk of developing hypertension in individuals with a sedentary lifestyle is higher than in individuals who engage in regular physical activity.
In addition, new exercise programs such as mat pilates exercises are also applied to hypertensive individuals. Mat pilates exercises are a resistance exercise method used worldwide, especially for middle-aged individuals who do not engage in regular physical activity. In addition, Mat pilates exercises have promising effects, reducing short-term systolic blood pressure by 7.4 mmHg and long-term resting systolic blood pressure by 5.8-7.6 mmHg and diastolic blood pressure by 3.3-3.6 mmHg. These data require further research on the use of mat pilates exercises in hypertensive individuals.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Other: Aerobic ExerciseIndividuals 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. |
| Mat Pilates Exercise Group | Active comparator | Other: Mat Pilates ExerciseIndividuals 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. |
| 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Aerobic ExerciseIndividuals 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 Group |
| Mat Pilates ExerciseIndividuals 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 Group |
Primary outcome
Blood Pressure
Time frame: 2 months
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.
Functional Capacity
Time frame: 2 months
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.
1 secondary outcome
Quality of life
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 33280503Saco-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.
- Background: PubMed 35438082Ramirez-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.
- Background: PubMed 33630677Caminiti 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.
- Background: PubMed 38876689Carlin 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.
- Background: PubMed 25464462Martins-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.
- Individual participant dataSharing planned: Undecided
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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.
Alis Kostanoğlu, PhD contact
Çağla Yılmaz, BPT principal investigator
Bezmialem Vakif University
Alis Kostanoğlu, PhD study director
Bezmialem Vakif University
Ahmet Bacaksız, PhD study chair
Bezmialem Vakif 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 Aerobic Exercise and Mat Pilates Exercise in people with Hypertension, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Çağla Yılmaz, BPT (5370101901 ext. +90, caglayillllmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT06612099, which also lists 5 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 1 Oct 2024.