NCT01429662

Brief Summary

The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR) technique over no MR for treating hypertension in Thai postmenopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
429

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

September 3, 2011

Last Update Submit

May 27, 2012

Conditions

Postmenopausal SyndromeHypertension

Keywords

postmenopausehypertensionrelaxationSBP 140-159 mmHgDBP 90-99 mmHgstage 1 or mild hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in SBP.

    Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.

    16 weeks

Secondary Outcomes (4)

  • Changes in DBP.

    16 weeks

  • Continuation rate of MR practice.

    16 weeks

  • Drop-out rates.

    16 weeks

  • Numbers of subjects who require anti-hypertensive medication.

    16 weeks

Study Arms (2)

Lifestyle Education (LE)

SHAM COMPARATOR

Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.

Behavioral: Lifestyle Education (LE)

Modified Relaxation (MR)

EXPERIMENTAL

Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.

Behavioral: Modified Relaxation (MR)

Interventions

Modified Relaxation (MR)BEHAVIORAL

Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.

Also known as: Behavioral Relaxation
Modified Relaxation (MR)
Lifestyle Education (LE)BEHAVIORAL

Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.

Also known as: Lifestyle Modification
Lifestyle Education (LE)

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 1 essential hypertension, defined as a systolic blood pressure of 140-159 and/or DBP of 90-99 mmHg on two occasions at least 30 minutes apart.
  • Women who are able to attend follow visits as advised.

You may not qualify if:

  • Women with systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg.
  • Women who have other known causes of hypertension, such as renal diseases
  • Women who are using sedatives or tranquilizer,or antidepressant, or antihypertensive medication during the past 2 months prior to the study.
  • Have language or geographical barrier.
  • Do not give their informed consent.
  • Women who need to be prescribed HRT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahasarakham Hospital

Maha Sarakham, Northeast, 44000, Thailand

Location

Related Publications (1)

  • Saensak S, Vutyavanich T, Somboonporn W, Srisurapanont M. Modified relaxation technique for treating hypertension in Thai postmenopausal women. J Multidiscip Healthc. 2013 Oct 3;6:373-8. doi: 10.2147/JMDH.S51580. eCollection 2013.

    PMID: 24124377DERIVED

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Suprawita Saensak, PhDcandidate

    PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate (Clinical Epidemiology)

Study Record Dates

First Submitted

September 3, 2011

First Posted

September 7, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

TH(1)