NCT00791986

Brief Summary

The purpose of this study is to determine whether adding load to slow controlled breathing training could enhance blood pressure lowering in patients with essential hypertension.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

November 14, 2008

Last Update Submit

March 5, 2018

Conditions

Essential Hypertension

Keywords

Breathing exerciseblood pressurehypertension

Outcome Measures

Primary Outcomes (1)

  • Home blood pressure

    Pre- and post - 8 weeks of intervention at rest

Secondary Outcomes (3)

  • Office blood pressure

    Pre- and post- 8 weeks of intervention at rest

  • Exercising blood pressure

    Blood pressure during exercise at pre- and post-8 weeks of intervention

  • Heart rate variability

    Heart rate variability at pre-and post- 8 weeks of intervention

Study Arms (3)

control

NO INTERVENTION

The patients in this control group do not conduct any breathing training.

ULB

EXPERIMENTAL

The patients conduct controlled slow breathing training using the WPTB device without inspiratory resistance.

Device: ULB , LB

LB

EXPERIMENTAL

The patients breath in against resistance using WPTB device.

Device: ULB , LB

Interventions

ULB , LBDEVICE

ULB: The patients breath in slowly without resistance via the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks. LB : The patients breath in slowly against resistance of 20 cmH2O provided by the water pressure threshold breathing (WPTB) device, 30 min/day, 7 days/week for 8 weeks.

Also known as: Guided breathing training, Paced breathing training, Controlled breathing training
LBULB

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of essential hypertension stage I-II

You may not qualify if:

  • Respiratory disease
  • Diabetes mellitus
  • Heart disease
  • Renal disease
  • Cerebrovascular disease
  • Dyslipidemia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiopulmonary Physical Therapy Research Room, Faculty of Asociated Medical Sciences, Khon Kaen University.

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • - Seals DR, Suwarno NO, Joyner MJ et al.Respiratory modulation of muscle sympathetic nerve activity in intact and lung denervated humans. Circulation Research 72(2): 440-454,1993. - Rosenthal T, Alter A, Peleg E, Gavish B. Device-guided breathing exercises reduce blood pressure: ambulatory and home measurements. Am J Hypertens 14(1):74-76,2001. - Viskoper R, Shapira I, Priluck R et al.Nonpharmacologic treatment of resistant hypertensive by device-guided slow breathing exercises. Am J Hypertens 16(6): 484-487,2003. - Grossman E, Grossman A, Schein MH et al.Breathing-control lowers blood pressure. J Hum Hypertens 15(4): 263-269,2001. - Viskoper R, Shapira I, Priluck R et al.Nonpharmacologic treatment of resistant hypertensive by device-guided slow breathing exercises. Am J Hypertens 16(6):484-487,2003 - Meles E, Giannattasio C, Failla M. et al.Non-pharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens 17(4):370-374,2004.

    BACKGROUND

MeSH Terms

Conditions

Essential HypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Chulee U Jones, Ph.D.

    Department of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University.

    STUDY CHAIR

  • Benjarat Sangthong, M.Sc.

    Faculty of Physical Therapy, Rungsit University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of associated medical science

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

TH(1)