TRiHYP: TeleRehabilitation in Hypertension

Sponsor

KU Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT02705911

Collaborator

Research Foundation Flanders (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Pre-hypertension Healthy	Other: Isometric handgrip exercise Other: Aerobic endurance training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

change in office blood pressure at 8 weeks of follow-up [8 weeks - 6 months]

Secondary Outcome Measures

change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up [8 weeks - 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

KU Leuven
Research Foundation Flanders

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Véronique Cornelissen, PhD, KU Leuven

ClinicalTrials.gov Identifier:

NCT02705911

Other Study ID Numbers:

1502214N

First Posted:

Mar 11, 2016

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Additional relevant MeSH terms:

Hypertension

Prehypertension

Study Results

No Results Posted as of Mar 8, 2022