Trial of Nonpharmacologic Interventions in Elderly (TONE)
NCT ID: NCT00000535
Last Updated: 2016-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1992-04-30
1997-03-31
Brief Summary
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Detailed Description
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An estimated 30 to 40 percent of elderly persons are treated with blood pressure medications. The efficacy of blood pressure drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven, but such therapy can adversely affect quality of life and biochemical profile. In 1992 when the study started, there was a compelling rationale to identify what proportion of medicated, well-controlled elderly hypertensives could be maintained long-term or greater than 30 months in the normotensive state following withdrawal of blood pressure medications. There was also a need to determine whether nonpharmacologic therapy could significantly increase the proportion with a successful outcome.
DESIGN NARRATIVE:
Randomized. A total of 585 overweight subjects were assigned in a 2 x 2 factorial design to weight loss, sodium reduction, combined weight loss and sodium reduction, or usual life-style control. The remaining 390 subjects of normal weight were assigned in a 2-armed design to a sodium reduction or an attention control group. The control groups were engaged in a series of non-blood pressure related health encounters designed to control for non-specific effects of groups contacts. Withdrawal of antihypertensive medication was attempted following three months of intervention. The primary endpoint was a blood pressure of 150/90 mm Hg or greater, resumption of antihypertensive drug therapy, or the occurrence of a blood pressure-related clinical complication during two to three years of follow-up. Recruitment ended in June, 1994. Follow-up ended in December, 1995. NHLBI support for the trial ended in March, 1997. The NIA supported the Coordinating Center and two clinical centers through February 1998.
The study completion date listed in this record was obtained from the "Completed Date" entered from the old format in the Protocol Registration and Results System (PRS).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
Interventions
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diet, reducing
diet, sodium-restricted
Eligibility Criteria
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Inclusion Criteria
60 Years
80 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Principal Investigators
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Walter Ettinger
Role:
Bowman Gray School of Medicine
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
University of Tennessee
Memphis, Tennessee, United States
Countries
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References
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