The aim of this trial is to investigate if modifications to exercise and diet have any effect on neurocognitive functions (functions controlled by the brain). The main outcomes to be investigated are changes in executive function (behavioral control and decision making), processing speed (the ability to process information) and memory.
The details
Patients with hypertension have an increased risk of stroke. Strokes are a known risk factor for neurocognitive dysfunction and dementia. Resistant hypertension is a condition where blood pressure is consistently high and usually requires treatment with three or more drugs. The risk of stroke is higher in patients with resistant hypertension. Intense drug treatment is not always effective and can cause unwanted side effects.
Lifestyle changes are often recommended as a non-drug treatment for patients with hypertension. These include weight loss, increasing physical activity and decreasing alcohol intake. The DASH diet is a specialized diet that can help lower blood pressure.
Lifestyle improvements have been shown to improve neurocognitive function in non-hypertensive patients. The aim of this study is to examine the effects in patients with resistant hypertension.
Who are they looking for?
This trial will recruit about 120 patients who have been diagnosed with resistant hypertension in the past 6 months. Patients who have been taking 3 or more drugs and have a systolic blood pressure (SBP – pressure when heart beats) greater than 140 mm HG or diastolic blood pressure (DBP – pressure when the heart is relaxed) greater than 90 mm Hg are eligible. Patients who have been taking 4 or more drugs and have an SBP greater than 130 mm HG or DBP greater than 85 mm Hg are also eligible. Participants must adhere to their prescribed medications and lead a generally inactive lifestyle.
Patients must not have secondary hypertension, asthma, lung disease, cancer, any life-threatening illness, or severe heart disease. Patients must be able to take part in the fitness program assigned to them. Individuals with psychiatric disorders or a history of drug or alcohol abuse or those who have had gastric bypass surgery are not eligible.
How will it work
Patients are randomly assigned to one of 2 groups. The first group will undergo a structured centre-based lifestyle intervention. This will consist of weekly visits to the centre for 4 months. They will receive instructions on the DASH diet for calorie and sodium intake. They will exercise 3 times a week under the supervision of trained staff.
The second group will receive standard education and advice. This includes encouragement to achieve ideal body weight and engage in regular exercise.
The main outcomes to be assessed are changes in executive function, processing ability, and memory over a period of 4 months.
