Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs (POTENT)

July 9, 2020 updated by: Martin Joergensen, Aalborg University Hospital

Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs: a 20-week Assessor-blindEd raNdomized Controlled Trial

This Study evaluates the effect of 20 weeks of isometric handgrip (IHG) home training in adults aged 50 years or more. Half of the participants will serve as a control group and will only receive hypertension-guidelines on lifestyle changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypertension markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications such as increased levels of physical activity are recommended as the first line of anti-hypertensive treatment. A recent systematic review showed that isometric handgrip (IHG) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (SBP). The average length of previous IHG training studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10 week mark. Recently, the investigators developed a novel method for monitoring handgrip intensity using a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects of 20-weeks IHG home training facilitated by a Wii in hypertensive older adults (+50 years of age) in lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling off effect on SBP will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the IHG home training.

Methods: Based on previous evidence, the investigators calculated that 50 hypertensive older adults (+50 years of age) is needed to achieve a power of 80% or more. Participants will be randomly assigned to either an intervention group (IHG home training + hypertension-guidelines on lifestyle changes) or to a control group (hypertension-guidelines on lifestyle changes). Participants in the intervention group will perform IHG home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20-weeks.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Aalborg, Danmark, Denmark, 9000
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age +50 years old
  2. Un-medicated (anti-hypertensive medicine) with resting SBP between 135-179 mmHg or hypertensive patient medicated with no change in treatment for ≥ 4 months with resting SBP between 135-179 mmHg

Exclusion Criteria:

  1. Manifest cardiovascular disease (cerebrovascular disease, Heart failure, Chronic Kidney Disease, peripheral vascular disease, and advanced retinopathy (fundus hypertonus III-IV)).
  2. Diabetes (any type)
  3. More than three blood pressure regulating agents
  4. Physical limitation preventing IHG training (e.g. missing an arm or musculoskeletal disorders).
  5. Arthritis in the hand or carpal tunnel
  6. SBP ≥ 180 mmHg (will be advised to see a doctor)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IHG+Hypertension lifestyle guidelines
Participants in this group will follow a home-based IHG training protocol. The IHG training will be structured with four sets of 2-minute contractions for each hand, 3 days per week for 20 weeks. In addition, the IHG group will receive information about hypertension-guidelines on lifestyle changes.
Other: IHG home training
Participants of the intervention group will follow the IHG home training protocol for 20 weeks. The IHG training consists of isometric contractions applied with the hands on a Wii.
NO_INTERVENTION: Hypertension lifestyle guidelines
The usual care group will receive information about hypertension-guidelines on lifestyle changes. The usual care group will have the same amount of hospital visits for measurements of blood pressure and maximal muscle tests as the intervention group in order to ensure similar attention provided by the healthcare professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: after 20 weeks of training
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
after 20 weeks of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure
Time Frame: after 20 weeks of training
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
after 20 weeks of training
heart rate
Time Frame: after 20 weeks of training
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
after 20 weeks of training
Handgrip maximum strength
Time Frame: baseline, 5 week, 15 weeks, and 20 weeks followup
This will be measured using the WII and reported in kilograms in the FysioMeter software
baseline, 5 week, 15 weeks, and 20 weeks followup
Handgrip Rate of force development
Time Frame: baseline, 5 week, 15 weeks, and 20 weeks followup
measured using a specially designed software working together with a standard wii board.
baseline, 5 week, 15 weeks, and 20 weeks followup
Handgrip Force variability
Time Frame: after 20 weeks of training
This will be a measure of the muscle force variability during the isometric training sessions throughout the study
after 20 weeks of training
Visual Analog Pain Scale (VAS)
Time Frame: after 20 weeks of training
At the end of each training session. Pain will be assessed for each hand/side using the VAS scale
after 20 weeks of training
Compliance to training sessions
Time Frame: after 20 weeks of training
A report will be generated on how many sessions each participant have completed during the study
after 20 weeks of training
Systolic blood pressure
Time Frame: week 25, 35, and 40 post-intervention
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
week 25, 35, and 40 post-intervention
Diastolic blood pressure
Time Frame: week 25, 35, and 40 post-intervention
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
week 25, 35, and 40 post-intervention
heart rate
Time Frame: week 25, 35, and 40 post-intervention
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
week 25, 35, and 40 post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Odense University Hospital
Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2017

Primary Completion (ACTUAL)

July 9, 2020

Study Completion (ACTUAL)

July 9, 2020

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POTENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data from the study will be made available on a public server

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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