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Completed

NCT Number: NCT03069443

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

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.

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Key information

Age range

50 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University hospital

Aalborg, Danmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age +50 years old
  • 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

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

Treatment and study plan

IHG home training

Other

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.

Primary outcomes

  1. Systolic blood pressure

    Time frame: after 20 weeks of training

    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

Secondary outcomes

  1. Diastolic blood pressure

    Time frame: after 20 weeks of training

    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

  2. heart rate

    Time frame: after 20 weeks of training

    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. Systolic blood pressure

    Time frame: week 25, 35, and 40 post-intervention

    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

  9. Diastolic blood pressure

    Time frame: week 25, 35, and 40 post-intervention

    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

  10. heart rate

    Time frame: week 25, 35, and 40 post-intervention

    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aalborg University
  • Odense University Hospital

Registry information

Official study title

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

Acronym: POTENT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2017
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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