Back to resultsTeleRehabilitation 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
About this trial
This is an interventional treatment trial for Hypertension
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
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
NCT ID
NCT02705911
First Posted
March 3, 2016
Last Updated
March 7, 2022
Sponsor
KU Leuven
Collaborators
Research Foundation Flanders
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
Learn more about this trial
TeleRehabilitation in Hypertension
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