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Completed

NCT Number: NCT02705911

TeleRehabilitation in Hypertension

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?

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Healthy Pre-Hypertension Prehypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isometric handgrip exercise

Other

Participants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device;

Aerobic endurance training

Other

To perform 150 minutes extra/week at moderate aerobic intensity

Primary outcomes

  1. change in office blood pressure at 8 weeks of follow-up

    Time frame: 8 weeks - 6 months

Secondary outcomes

  1. change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up

    Time frame: 8 weeks - 6 months

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Research Foundation Flanders

Registry information

Official study title

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

Acronym: TRiHYP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2016
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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