Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women

May 27, 2012 updated by: Suprawita Saensak, Chiang Mai University

Phase 3 Study of Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Medical treatment of hypertension (HTN) in postmenopausal women is not very effective, as it requires co-operation and long-term commitment from the patients and their families. The medication itself may cause bothersome side effects and it can pose economic burden to the patients and the society. In contrast, lifestyle modifications, particularly relaxation technique, are less costly and relatively free of any side effects. Once the patients master the techniques, they can practice by themselves at home and at any time that is convenient to them. There is evidence from at least one RCT that the techniques are effective in reducing the systolic blood pressure (SBP) and diastolic blood pressure (DBP), even after a short practice of only two months.

In this study, the investigators propose a randomized control trial to examine the effectiveness of modified relaxation (MR) technique to control HTN in Thai postmenopausal women against a control group who practice no MR. Such a study in Thai population has not been done before. In addition, the investigators will extend the period of observation up to 16 weeks, to assess longer-term patients' compliance, and the effects of MR on BP.

Study Type

Interventional

Enrollment (Actual)

429

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Northeast
      • Maha Sarakham, Northeast, Thailand, 44000
        • Mahasarakham Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Lifestyle Education (LE)
Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Behavioral: Lifestyle Education (LE)
Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Other Names:
  • Lifestyle Modification
Experimental: Modified Relaxation (MR)
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)
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.
Other Names:
  • Behavioral Relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in SBP.
Time Frame: 16 weeks
Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in DBP.
Time Frame: 16 weeks
Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.
16 weeks
Continuation rate of MR practice.
Time Frame: 16 weeks
Measure the continuation rate of MR practice after 4 months of follow-up period.
16 weeks
Drop-out rates.
Time Frame: 16 weeks
Measure the drop-out rate after intervention at 1, 2, 3, and 4 months of follow-up period.
16 weeks
Numbers of subjects who require anti-hypertensive medication.
Time Frame: 16 weeks
Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Suprawita Saensak, PhDcandidate, PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 3, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 27, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRLE-HTN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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