NCT03791307

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 18, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 8, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

December 18, 2018

Last Update Submit

March 24, 2020

Conditions

Hypertension

Keywords

Pilates methodBlood pressureAutonomic heart rate modulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Clinical blood pressure

    Change from Baseline systolic and diastolic Blood Pressure at 16 weeks

  • Clinical heart rate

    Change from Baseline clinical heart rate at 16 weeks

  • Autonomic heart rate modulation

    Change from Baseline autonomic heart rate modulation at 16 weeks

  • Ventilatory threshold measured by the cardiopulmonary exercise test

    Change from baseline and at 16 weeks

  • Analysis of the quality of life

    Change from Baseline quality of life at 16 weeks

  • +9 more secondary outcomes

Study Arms (3)

Traditional Pilates group

EXPERIMENTAL

This group will perform only exercises based on the traditional Pilates method

Other: Traditional Pilates group

Modified Pilates group

EXPERIMENTAL

This group will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer

Other: Modified Pilates group

Control group

NO INTERVENTION

This group will not perform any physical exercise during the trial period.

Interventions

Traditional Pilates groupOTHER

The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.

Traditional Pilates group
Modified Pilates groupOTHER

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.

Modified Pilates group

Eligibility Criteria

Age30 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Brasilia

Brasília, Federal District, 72220-900, Brazil

Location

Related Publications (13)

  • 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

  • Carpio-Rivera E, Moncada-Jimenez 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.

    PMID: 27168471BACKGROUND

  • 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. doi: 10.1590/s0034-89102000000200012. Portuguese.

    PMID: 10881154BACKGROUND

  • Gonzales 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.

    PMID: 27622959BACKGROUND

  • Malachias MV. 7th Brazilian Guideline of Arterial Hypertension: Presentation. Arq Bras Cardiol. 2016 Sep;107(3 Suppl 3):0. doi: 10.5935/abc.20160140. No abstract available.

    PMID: 27819379BACKGROUND

  • Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.

    PMID: 15313543BACKGROUND

  • 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.

    PMID: 26423529BACKGROUND

  • 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.

    PMID: 24875976BACKGROUND

  • 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.

    PMID: 23874763BACKGROUND

  • 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. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.

    PMID: 12821592BACKGROUND

  • 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. No abstract available.

    PMID: 24341872BACKGROUND

  • 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.

    PMID: 23217437BACKGROUND

  • da Silva Almeida I, de Souza Andrade L, de Sousa AMM, Junior GC, Turri-Silva N, Cunha Nascimento DD, Mota YL, Durigan JLQ. The Effect of Mat Pilates Training Combined With Aerobic Exercise Versus Mat Pilates Training Alone on Blood Pressure in Women With Hypertension: A Randomized Controlled Trial. Phys Ther. 2022 Feb 1;102(2):pzab258. doi: 10.1093/ptj/pzab258.

    PMID: 35084038DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • João LQ Durigan, PhD

    University of Brasilia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
One researcher will be blinded to the conduct of evaluations and revaluations. One researcher will be blinded for outcomes statistics analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapist, Assistant Professor

Study Record Dates

First Submitted

December 18, 2018

First Posted

January 2, 2019

Study Start

April 8, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

BR(1)