TeleRehabilitation in Hypertension

NCT ID: NCT02705911

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-07-31

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?

Conditions

Hypertension; Pre-hypertension; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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;

Group Type: EXPERIMENTAL

Isometric handgrip exercise

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Aerobic endurance training

Intervention Type: OTHER

To perform 150 minutes extra/week at moderate aerobic intensity

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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;

Intervention Type: OTHER

Aerobic endurance training

To perform 150 minutes extra/week at moderate aerobic intensity

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Véronique Cornelissen

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

1502214N

Identifier Type: -

Identifier Source: org_study_id