Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf

About this trial

This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

no written informed consent

age <18 years

isolated diastolic hypertension

medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individualized exercise therapy

    Behavioral

    Patients in the intervention group will receive an individualized exercise training program 3x/week.

  • Lifestyle recommendations

    Behavioral

    The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Individualized exercise training groupActive comparator 2 interventions
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

The retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).

Time frame
From enrollment to the end of treatment after six month.
2

Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters.

Changes of retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).

Time frame
From enrollment to the end of treatment after six month.

Secondary outcomes

1

The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the systolic and diastolic blood pressure compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

Changes in unattended systolic and diastolic blood pressure in mm Hg.

Time frame
From enrollment to the end of treatment after six month.
2

Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure.

Changes in unattended systolic and diastolic blood pressure in mm Hg.

Time frame
From enrollment to the end of treatment after six month.
3

The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the microvascular endothelial function compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation.

Time frame
From enrollment to the end of treatment after six month.
4

Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.

Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation.

Time frame
From enrollment to the end of treatment after six month.

Other outcomes

1

The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on fat and muscle mass compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

Changes in fat and muscle mass will be investigated by bioimpedance analysis.

Time frame
From enrollment to the end of treatment after six month.
2

Effect of a guideline based anti-hypertensive therapy on fat and muscle mass.

Changes in fat and muscle mass will be investigated by bioimpedance analysis.

Time frame
From enrollment to the end of treatment after six month.
3

The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on intra- and extracellular water volume compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

Changes in intra- and extracellular water volume will be investigated by bioimpedance analysis.

Time frame
From enrollment to the end of treatment after six month.
4

Effect of a guideline based anti-hypertensive therapy on intra- and extracellular water volume.

Changes in intra- and extracellular water volume will be investigated by bioimpedance analysis.

Time frame
From enrollment to the end of treatment after six month.

Sponsors and contacts

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