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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429662
• Other study ID #: MRLE-HTN
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2011
• Last updated: May 27, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Postmenopausal Syndrome

Intervention

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

Locations

Country	Name	City	State
Thailand	Mahasarakham Hospital	Maha Sarakham	Northeast

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in SBP.	Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.	16 weeks	No
Secondary	Changes in DBP.	Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.	16 weeks	No
Secondary	Continuation rate of MR practice.	Measure the continuation rate of MR practice after 4 months of follow-up period.	16 weeks	No
Secondary	Drop-out rates.	Measure the drop-out rate after intervention at 1, 2, 3, and 4 months of follow-up period.	16 weeks	No
Secondary	Numbers of subjects who require anti-hypertensive medication.	Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period.	16 weeks	No

External Links

•   International Journal of Hypertension is a peer-reviewed, open access journal that publishes original research articles, review articles, and clinical studies in all areas of hypertension.
•   NIH is the nation's medical research agency—supporting scientific studies that turn discovery into health.
•   PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books.
•   The Journal of Behavioral Medicine is a broadly conceived interdisciplinary publication devoted to furthering understanding of physical health and illness through the knowledge and techniques of behavioral science.
•   The Journal of North American Menopause Society is a peer-reviewed scientific journal owned by NAMS and published by Lippincott Williams & Wilkins (LWW).