Effects of Training Based on the Pilates Method on the Blood Pressure of Hypertensive Women

Hypertension Clinical Trial

Official title:

Blood Pressure, Autonomic Heart Rate Modulation, Cardiorespiratory Parameters, Functionality and Quality of Life in Hypertensive Women After 16 Weeks of Training Based on the Pilates Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791307
• Other study ID #: CAEE: 99221818.9.0000.0029
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2020
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate and compare the effect of the Pilates method associated with aerobic exercise and the traditional Pilates method on the blood pressure of hypertensive medicated women. In addition, we aim to analyze and compare the chronic effects of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and quality of life.

Description:

Subjects will be allocated randomly in three groups: (1) Traditional Pilates group, which will perform only exercises based on the traditional Pilates method, (2) Modified Pilates group, which will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, (3) Control group: will not perform any physical exercise during the trial period. The sessions will be performed two times a week, during 16 weeks. Subjects will be evaluated before and after 16 weeks of intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• Hypertensive women

• Age 30 to 59

• Sedentary or who do not practice any form of physical exercise regularly for at least 6 months

• Make use of antihypertensive medication

• Who have medical clearance for physical exercise

Exclusion Criteria:

• Complaint of pain that influences or makes the performance of the tests / exercises proposed impossible

• Congenital or acquired anomalies of upper limbs and lower limbs

• Presence of musculoskeletal disease or injury that interfere the performance of exercises

• Changes in pharmacological treatment during the experimental period

• Release for physical activity suspended during intervention

• Absence in more than 25% of the exercise sessions

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Traditional Pilates group
The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.
• Modified Pilates group
The participants will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, 2 times a week, for 50 minutes, for 16 weeks.

Locations

Country	Name	City	State
Brazil	University of Brasilia	Brasília	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
João Luiz Q. Durigan	Catholic University of Brasília

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

Carpio-Rivera E, Moncada-Jiménez J, Salazar-Rojas W, Solera-Herrera A. Acute Effects of Exercise on Blood Pressure: A Meta-Analytic Investigation. Arq Bras Cardiol. 2016 May;106(5):422-33. doi: 10.5935/abc.20160064. Epub 2016 May 6. Review. English, Portuguese. — View Citation

Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. Portuguese. — View Citation

Gonzáles AI, Nery T, Fragnani SG, Pereira F, Lemos RR, Bezerra PP, Haas P. Pilates Exercise for Hypertensive Patients: A Review of the Literature. Altern Ther Health Med. 2016 Sep;22(5):38-43. Review. — View Citation

Malachias MV. 7th Brazilian Guideline of Arterial Hypertension: Presentation. Arq Bras Cardiol. 2016 Sep;107(3 Suppl 3):0. doi: 10.5935/abc.20160140. English, Portuguese. — View Citation

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. — View Citation

Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. — View Citation

Pescatello LS, MacDonald HV, Lamberti L, Johnson BT. Exercise for Hypertension: A Prescription Update Integrating Existing Recommendations with Emerging Research. Curr Hypertens Rep. 2015 Nov;17(11):87. doi: 10.1007/s11906-015-0600-y. Review. — View Citation

Prinsloo GE, Rauch HG, Derman WE. A brief review and clinical application of heart rate variability biofeedback in sports, exercise, and rehabilitation medicine. Phys Sportsmed. 2014 May;42(2):88-99. doi: 10.3810/psm.2014.05.2061. Review. — View Citation

Rtveladze K, Marsh T, Webber L, Kilpi F, Levy D, Conde W, McPherson K, Brown M. Health and economic burden of obesity in Brazil. PLoS One. 2013 Jul 11;8(7):e68785. doi: 10.1371/journal.pone.0068785. Print 2013. — View Citation

Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. — View Citation

Weber MA, Schiffrin EL, White WB, Mann S, Lindholm LH, Kenerson JG, Flack JM, Carter BL, Materson BJ, Ram CV, Cohen DL, Cadet JC, Jean-Charles RR, Taler S, Kountz D, Townsend RR, Chalmers J, Ramirez AJ, Bakris GL, Wang J, Schutte AE, Bisognano JD, Touyz RM, Sica D, Harrap SB. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014 Jan;16(1):14-26. doi: 10.1111/jch.12237. Epub 2013 Dec 17. — View Citation

Xhyheri B, Manfrini O, Mazzolini M, Pizzi C, Bugiardini R. Heart rate variability today. Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):321-31. doi: 10.1016/j.pcad.2012.09.001. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure	Systolic and diastolic blood pressure will be measured by 24-hour Ambulatorial Monitoring Blood Pressure, before and after trial period.	Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Secondary	Clinical blood pressure	Clinical assessment of systolic and diastolic blood pressure will be measured by an automatic arm blood pressure monitor after 10 minutes of rest, before and after trial period.	Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Secondary	Clinical heart rate	Clinical assessment of heart rate will be measured by a heart rate monitor after 10 minutes of rest, before and after trial period.	Change from Baseline clinical heart rate at 16 weeks
Secondary	Autonomic heart rate modulation	Autonomic heart rate modulation will be assessed by the heart rate variability method using a heart rate monitor, before and after trial period.	Change from Baseline autonomic heart rate modulation at 16 weeks
Secondary	Ventilatory threshold measured by the cardiopulmonary exercise test	The ventilatory threshold will be measured by the cardiopulmonary exercise test. An ergospirometric exercise test will be performed, consisting of increasing loads, with no pauses between the stages until exhaustion of the volunteer. The examination will be performed in a treadmill with ergospirometric and electrocardiographic analysis.	Change from baseline and at 16 weeks
Secondary	Analysis of the quality of life	Quality of life will be analyzed by means of the questionnaire World Health Organization Quality Of Life/Bref (WHOQOL/bref). The questionnaire has twenty-six questions that involve different aspects of daily life and deal with four domains of quality of life: physical, psychological, environmental and social relations. The response is represented by scores ranging from one to five, with the worst score being one and the best score being five. The results of the domains have values between zero and one hundred, with the worst being the closest to zero and the best the closest to one hundred, thus, a value equal to 50 for a given domain can be considered median for that domain.	Change from Baseline quality of life at 16 weeks
Secondary	Flexibility	Flexibility will be analyzed by bank of wells test, before and after trial period.	Change from Baseline flexibility at 16 weeks
Secondary	Strength	Strength will be analyzed by hydraulic handgrip dynamometer, before and after trial period.	Change from Baseline strength at 16 weeks
Secondary	Speed to lift from a sitting position	Speed to lift from a sitting position will be evaluated by a stopwatch, before and after trial period.	Change from Baseline speed at16 weeks
Secondary	Speed to lift from a layered position	Speed to lift from a layered position will be evaluated by a stopwatch, before and after trial period	Change from Baseline speed at 16 weeks
Secondary	Speed to put on and tie his shoes	Speed to put on and tie his shoes will be evaluated by a stopwatch, before and after trial period.	Change from Baseline speed at 16 weeks
Secondary	Body weight	Body weight will be measured using a digital scale, before and after trial period.	Change from Baseline body weight at 16 weeks
Secondary	Height	Height will be measured using a stadiometer.	Change from Baseline at 16 weeks
Secondary	Body Mass Index	Will be analyzed as weight divided by height squared.	Change from Baseline body mass index at 16 weeks
Secondary	Circumference measurements	Will be analyzed the circumference of hip, waist, neck, abdomen, before and after trial period.	Change from Baseline circumference measurements at 16 weeks