TeleRehabilitation in Hypertension

Overview

The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations.

II. To assess whether isometric handgrip training yields larger BP reductions beyond the supervised training period at 6 months of follow-up.

III. To determine whether changes in BP following acute exercise and chronic training can be explained by changes in important physiological mechanisms known to mediate or to be associated with BP?

Full Title of Study: “Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Interventions

  • Other: Isometric handgrip exercise
    • Participants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device;
  • Other: Aerobic endurance training
    • To perform 150 minutes extra/week at moderate aerobic intensity

Arms, Groups and Cohorts

  • Experimental: Isometric Handgrip training
    • Participants are asked to perform daily 4 x 2 minute contractions with alternating hands , separated with 1 minute rest period using a ZonaHealth device;
  • Active Comparator: Aerobic endurance training
    • Participants are asked to perform at least 150 minutes extra of moderate aerobic exercise per week
  • No Intervention: Control
    • Participants are asked to continue with their daily routine and not to perform extra exercise.

Clinical Trial Outcome Measures

Primary Measures

  • change in office blood pressure at 8 weeks of follow-up
    • Time Frame: 8 weeks – 6 months

Secondary Measures

  • change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up
    • Time Frame: 8 weeks – 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • not physically active (< 3 hours of moderate to high levels of PA/week) low cardiovascular risk according to current guidelines (Mancia et al J Hypertens 2013) will be recruited through advertisements. The latter is defined as:
  • >115 mmHg < systolic BP < 139 mmHg and/or 75 mmHg< diastolic BP<90mmHg in the presence of 0 to a maximum of three other cardiovascular risk factors, excluding diabetes Or
  • 139 mmHg < systolic BP < 160 mmHg and/or 90 mmHg<DBP< 100 mmHg in the absence of other cardiovascular risk factors

Exclusion Criteria

  • current smoker
  • pregnancy
  • presence of other cardiovascular disease, pulmonary disease or metabolic disease
  • inability to perform a standard exercise program due to mental/physical disability.
  • use of antihypertensive drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • KU Leuven
  • Collaborator
    • Research Foundation Flanders
  • Provider of Information About this Clinical Study
    • Principal Investigator: VĂ©ronique Cornelissen, PhD – KU Leuven
  • Overall Contact(s)
    • Veronique Cornelissen, PhD, 003216329152, veronique.cornelissen@faber.kuleuven.be

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