NCT03214016

Brief Summary

This study evaluates the effects of Pilates method and aerobic training in hypertensive subjects. Half of participants will be trained with Pilates, while the other half will be trained with aerobic exercise during 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

July 3, 2017

Last Update Submit

April 29, 2020

Conditions

Keywords

Pilates TrainingAerobic ExercisesHypertensionClinical trial

Outcome Measures

Primary Outcomes (2)

  • Change from baseline casual systolic blood pressure at 8 weeks

    It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff.

    baseline and 8 weeks

  • Change from baseline 24-hour systolic blood pressure at 8 weeks

    It will be evaluated by 24-hour ambulatory BP monitoring (ABPM)

    baseline and 8 weeks

Secondary Outcomes (17)

  • Casual diastolic blood pressure

    baseline and 8 weeks

  • Heart rate variability

    baseline and 8 weeks

  • Diastolic and mean blood pressure

    baseline and 8 weeks

  • Functional capacity

    baseline and 8 weeks

  • Respiratory muscle strength

    baseline and 8 weeks

  • +12 more secondary outcomes

Study Arms (2)

Pilates method group

EXPERIMENTAL

The participants will do Mat Pilates.

Other: Pilates

Aerobic training group

ACTIVE COMPARATOR

The participants will do aerobic exercise on treadmill.

Other: Aerobic Exercise

Interventions

1 hour of aerobic training on a treadmill, 3 times a week, during 8 weeks.

Also known as: aerobic training
Aerobic training group
PilatesOTHER

1 hour of Mat Pilates, 2 times a week, during 8 weeks.

Also known as: Pilates method, Mat Pilates
Pilates method group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with high blood pressure controled by medication;
  • sedentary.

You may not qualify if:

  • IMC≥30 kg/m²
  • using beta blockers
  • smokers or that interrupted the routine less than 6 months
  • musculoskeletal diseases in evolution or with current symptomatic
  • rheumatological diseases
  • other cardiovascular disease
  • renal disease due to hypertension
  • endocrine, neurological, oncological, immunological, hematological and psychiatric diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Federal of Santa Maria

Santa Maria, Rio Grande do Sul, 97.105-900, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

ExerciseExercise Movement Techniques

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy professor

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 11, 2017

Study Start

August 20, 2017

Primary Completion

May 30, 2018

Study Completion

August 31, 2018

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations