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TeleRehabilitation in Hypertension (TRiHYP)

Primary Purpose

Hypertension, Pre-hypertension, Healthy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Isometric handgrip exercise
Aerobic endurance training
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Isometric Handgrip training

Aerobic endurance training

Control

Arm Description

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

Participants are asked to perform at least 150 minutes extra of moderate aerobic exercise per week

Participants are asked to continue with their daily routine and not to perform extra exercise.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2016
Last Updated
March 7, 2022
Sponsor
KU Leuven
Collaborators
Research Foundation Flanders
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1. Study Identification

Unique Protocol Identification Number
NCT02705911
Brief Title
TeleRehabilitation in Hypertension
Acronym
TRiHYP
Official Title
Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Research Foundation Flanders

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pre-hypertension, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isometric Handgrip training
Arm Type
Experimental
Arm Description
Participants are asked to perform daily 4 x 2 minute contractions with alternating hands , separated with 1 minute rest period using a ZonaHealth device;
Arm Title
Aerobic endurance training
Arm Type
Active Comparator
Arm Description
Participants are asked to perform at least 150 minutes extra of moderate aerobic exercise per week
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants are asked to continue with their daily routine and not to perform extra exercise.
Intervention Type
Other
Intervention Name(s)
Isometric handgrip exercise
Intervention Description
Participants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device;
Intervention Type
Other
Intervention Name(s)
Aerobic endurance training
Intervention Description
To perform 150 minutes extra/week at moderate aerobic intensity
Primary Outcome Measure Information:
Title
change in office blood pressure at 8 weeks of follow-up
Time Frame
8 weeks - 6 months
Secondary Outcome Measure Information:
Title
change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up
Time Frame
8 weeks - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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TeleRehabilitation in Hypertension

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