What is the clinical evidence from this study?

Study design: RCT. Population: Prehypertension and mild hypertension (n=85). Intervention: DASH diet alone or with home-based exercise vs. Usual advice. Primary outcome: Difference in office systolic blood pressure (SBP) before and after the 8-week study period (p=0.347).

January 1, 2018Open Access

The Effects of Diet Alone or in Combination with Exercise in Patients with Prehypertension and Hypertension: a Randomized Controlled Trial

Key Result

A home-based intervention of DASH diet and exercise did not significantly reduce the primary endpoint of office systolic blood pressure compared to usual advice (-3.6 mmHg vs 2.0 mmHg, p=0.347).

Study Design

Type

RCT (n=85)

Blinding

Open-label

Randomization

permuted 6 block randomizations

Multicenter

Structured PICO

Does a home-based lifestyle modification intervention combining the DASH diet and exercise reduce blood pressure in patients with prehypertension or mild hypertension?

Population

85 adults over 20 years of age with prehypertension or mild hypertension were randomized to usual advice, DASH diet, or DASH diet plus home-based exercise for 8 weeks.

Intervention

Dietary Approaches to Stop Hypertension (DASH) diet education alone (n=30) or DASH diet education combined with a home-based exercise program (n=27) for 8 weeks.

Comparator

Advice-only comparison group (n=28) receiving usual care and advice on lifestyle modification from their physician based on guidelines for the management of arterial hypertension, with no additional education sessions.

Outcome

Difference in office systolic blood pressure (SBP) before and after the 8-week study period.surrogate

A home-based lifestyle modification program combining the DASH diet and exercise significantly reduced daytime ambulatory systolic blood pressure compared to usual care in patients with prehypertension or mild hypertension.

Main Result

Absolute Event Rate: -3.6% vs 2%

p-value: p=0.347

Limitations

Randomization bias with more obese and male patients in the diet plus exercise group
Patient adherence was not formally analyzed due to incomplete exercise diary submissions
The study may have been underpowered to detect a significant reduction in the primary endpoint of office blood pressure

Abstract

BACKGROUND AND OBJECTIVES: Supervised lifestyle interventions, including dietary and exercise programs, may be infeasible to implement in real-world settings. Therefore, this study aimed to evaluate the effectiveness of a home-based lifestyle modification intervention on blood pressure (BP) management. METHODS: Eighty-five patients aged over 20 years and diagnosed with prehypertension or mild hypertension were randomly assigned to an advice-only comparison group (C group, n=28), a Dietary Approaches to Stop Hypertension (DASH) diet education group (D group, n=30), or a DASH and home-based exercise group (D+Ex group, n=27). The intervention lasted for 8 weeks. The primary outcome was the difference in office systolic blood pressure (SBP) before and after the study period (Trial registry at ClinicalTrials.gov, NCT01637909). RESULTS: Seventy-two participants (87.8%) completed the trial. The degree of change in office SBP did not significantly differ among the intervention groups; however, the D+Ex group demonstrated a tendency toward decreased SBP. Upon analysis of 24-hour ambulatory BP measurements, daytime ambulatory SBP was significantly lower in the D+Ex group (134 mmHg; 95% confidence interval CI, 131 to 137; p=0.011) than in the C group (139.5 mmHg; 95% CI, 130.9 to 137), and daytime ambulatory SBP was significantly decreased in the D+Ex group (-5.2 mmHg; 95% CI, -8.3 to -2.1; p=0.011) compared to the C group (0.4 mmHg, 95% CI, -2.5 to 3.3). CONCLUSIONS: In conclusion, lifestyle modification emphasizing both diet and exercise was effective for lowering BP and should be favored over diet-only modifications.

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