Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000537
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
1999-10-27
Brief Title:
Stress Reduction CVD Morbidity and Mortality in Blacks
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the effects of two stress reduction techniques Transcendental Meditation TM and Progressive Muscle Relaxation PMR on the control of mild hypertension in elderly Blacks with hypertension
Detailed Description:
BACKGROUND
Life expectancy for Black Americans is about 10 percent less than for whites The leading cause of excessive mortality in older Blacks is cardiovascular disease which may be largely due to disproportionately high rates of hypertension in older Blacks Conventional antihypertensive drug therapies are frequently associated with adverse effects on quality-of-life QL and low compliance rates especially in elderly minority populations
The present study is an extension of a pilot study on a comparable sample of 80 Black elderly The previous study which was the first of its kind yielded results which indicated that both TM and PMR produced moderate reductions in systolic and diastolic blood pressure with TM producing the most significant improvements in blood pressure and in quality-of-life Dr Schneider hypothesized from this and related evidence that TM should prove to be an effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly Blacks and should prove even more effective in fostering compliance and in improving overall quality-of-life without any of the unpleasant side effects of anti-hypertensive medications
DESIGN NARRATIVE
Randomized Over an 18-month period 213 people were screened for inclusion in the study Of these 127 with initial diastolic blood pressure of 90 to 109 mm Hg systolic blood pressure of 189 mm Hg or less and final baseline blood pressure of 179104 or less mm Hg were randomized to treatment Of the 127 participants 16 did not complete follow-up blood pressure measurements Thus 111 subjects completed the study All subjects were pretested over a four session baseline period on clinic blood pressure ambulatory blood pressure cardiovascular and emotional reactivity and quality-of-life measures Subjects were then randomly assigned 36 to TM 37 to PMR and 38 to lifestyle modification education control and followed monthly with major post-tests at three months and eighteen months on these variables The primary outcome variables were changes in clinic systolic and diastolic blood pressure values measured blindly The secondary outcomes were changes in self-monitored home blood pressure and compliance
The study was extended through July 2007 for an additional 5 years of followup of the cohort
Life expectancy for Black Americans is about 10 percent less than for whites The leading cause of excessive mortality in older Blacks is cardiovascular disease which may be largely due to disproportionately high rates of hypertension in older Blacks Conventional antihypertensive drug therapies are frequently associated with adverse effects on quality-of-life QL and low compliance rates especially in elderly minority populations
The present study is an extension of a pilot study on a comparable sample of 80 Black elderly The previous study which was the first of its kind yielded results which indicated that both TM and PMR produced moderate reductions in systolic and diastolic blood pressure with TM producing the most significant improvements in blood pressure and in quality-of-life Dr Schneider hypothesized from this and related evidence that TM should prove to be an effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly Blacks and should prove even more effective in fostering compliance and in improving overall quality-of-life without any of the unpleasant side effects of anti-hypertensive medications
DESIGN NARRATIVE
Randomized Over an 18-month period 213 people were screened for inclusion in the study Of these 127 with initial diastolic blood pressure of 90 to 109 mm Hg systolic blood pressure of 189 mm Hg or less and final baseline blood pressure of 179104 or less mm Hg were randomized to treatment Of the 127 participants 16 did not complete follow-up blood pressure measurements Thus 111 subjects completed the study All subjects were pretested over a four session baseline period on clinic blood pressure ambulatory blood pressure cardiovascular and emotional reactivity and quality-of-life measures Subjects were then randomly assigned 36 to TM 37 to PMR and 38 to lifestyle modification education control and followed monthly with major post-tests at three months and eighteen months on these variables The primary outcome variables were changes in clinic systolic and diastolic blood pressure values measured blindly The secondary outcomes were changes in self-monitored home blood pressure and compliance
The study was extended through July 2007 for an additional 5 years of followup of the cohort
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: