TeleRehabilitation in Hypertension (TRiHYP)

March 7, 2022 updated by: Véronique Cornelissen, KU Leuven

Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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;
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;
ACTIVE_COMPARATOR: Aerobic endurance training
Participants are asked to perform at least 150 minutes extra of moderate aerobic exercise per week
Other: Aerobic endurance training
To perform 150 minutes extra/week at moderate aerobic intensity
NO_INTERVENTION: Control
Participants are asked to continue with their daily routine and not to perform extra exercise.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Research Foundation Flanders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (ESTIMATE)

March 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502214N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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