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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
IHG home training
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Isometric handgrip training, home training, older adults, Hypertension

Eligibility Criteria

50 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aalborg University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IHG+Hypertension lifestyle guidelines

Hypertension lifestyle guidelines

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diastolic blood pressure
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
heart rate
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Handgrip maximum strength
This will be measured using the WII and reported in kilograms in the FysioMeter software
Handgrip Rate of force development
measured using a specially designed software working together with a standard wii board.
Handgrip Force variability
This will be a measure of the muscle force variability during the isometric training sessions throughout the study
Visual Analog Pain Scale (VAS)
At the end of each training session. Pain will be assessed for each hand/side using the VAS scale
Compliance to training sessions
A report will be generated on how many sessions each participant have completed during the study
Systolic blood pressure
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Diastolic blood pressure
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
heart rate
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

Full Information

First Posted
January 13, 2017
Last Updated
July 9, 2020
Sponsor
Aalborg University Hospital
Collaborators
Odense University Hospital, Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03069443
Brief Title
Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs
Acronym
POTENT
Official Title
Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs: a 20-week Assessor-blindEd raNdomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
July 9, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Odense University Hospital, Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Isometric handgrip training, home training, older adults, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IHG+Hypertension lifestyle guidelines
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypertension lifestyle guidelines
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IHG home training
Intervention Description
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 Outcome Measure Information:
Title
Systolic blood pressure
Description
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time Frame
after 20 weeks of training
Secondary Outcome Measure Information:
Title
Diastolic blood pressure
Description
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time Frame
after 20 weeks of training
Title
heart rate
Description
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time Frame
after 20 weeks of training
Title
Handgrip maximum strength
Description
This will be measured using the WII and reported in kilograms in the FysioMeter software
Time Frame
baseline, 5 week, 15 weeks, and 20 weeks followup
Title
Handgrip Rate of force development
Description
measured using a specially designed software working together with a standard wii board.
Time Frame
baseline, 5 week, 15 weeks, and 20 weeks followup
Title
Handgrip Force variability
Description
This will be a measure of the muscle force variability during the isometric training sessions throughout the study
Time Frame
after 20 weeks of training
Title
Visual Analog Pain Scale (VAS)
Description
At the end of each training session. Pain will be assessed for each hand/side using the VAS scale
Time Frame
after 20 weeks of training
Title
Compliance to training sessions
Description
A report will be generated on how many sessions each participant have completed during the study
Time Frame
after 20 weeks of training
Title
Systolic blood pressure
Description
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time Frame
week 25, 35, and 40 post-intervention
Title
Diastolic blood pressure
Description
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time Frame
week 25, 35, and 40 post-intervention
Title
heart rate
Description
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time Frame
week 25, 35, and 40 post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Aalborg University hospital
City
Aalborg
State/Province
Danmark
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data from the study will be made available on a public server
Citations:
PubMed Identifier
29426359
Citation
Jorgensen MG, Ryg J, Danielsen MB, Madeleine P, Andersen S. Twenty weeks of isometric handgrip home training to lower blood pressure in hypertensive older adults: a study protocol for a randomized controlled trial. Trials. 2018 Feb 9;19(1):97. doi: 10.1186/s13063-018-2441-x.
Results Reference
derived

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

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