TeleRehabilitation in Hypertension

NCT02705911 | Completed

• 1 other identifier: 1502214N
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  8 weeks - 6 months

Secondary Outcomes (1)

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

  8 weeks - 6 months

Study Arms (3)

Isometric Handgrip training

EXPERIMENTAL

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

Aerobic endurance training

ACTIVE COMPARATOR

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

Other: Aerobic endurance training

Control

NO INTERVENTION

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

Interventions

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;

Isometric Handgrip training

Aerobic endurance training OTHER

To perform 150 minutes extra/week at moderate aerobic intensity

Aerobic endurance training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• mmHg \< systolic BP \< 160 mmHg and/or 90 mmHg\<DBP\< 100 mmHg in the absence of other cardiovascular risk factors

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

BE (1)