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

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ClinicalTrials.gov Identifier: NCT03069443
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Odense University Hospital
Aalborg University
Information provided by (Responsible Party):
Martin Joergensen, Aalborg University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: IHG home training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs: a 20-week Assessor-blindEd raNdomized Controlled Trial
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: after 20 weeks of training ]
    measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069443


Locations
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Denmark
Aalborg University hospital
Aalborg, Danmark, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Odense University Hospital
Aalborg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martin Joergensen, Senior researcher, cand. scient., PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03069443     History of Changes
Other Study ID Numbers: POTENT
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data from the study will be made available on a public server

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Joergensen, Aalborg University Hospital:
Isometric handgrip training
home training
older adults
Hypertension
Additional relevant MeSH terms:
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Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases