NCT03069443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

January 13, 2017

Last Update Submit

July 9, 2020

Conditions

Hypertension

Keywords

Isometric handgrip traininghome trainingolder adultsHypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

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

    after 20 weeks of training

Secondary Outcomes (10)

  • Diastolic blood pressure

    after 20 weeks of training

  • heart rate

    after 20 weeks of training

  • Handgrip maximum strength

    baseline, 5 week, 15 weeks, and 20 weeks followup

  • Handgrip Rate of force development

    baseline, 5 week, 15 weeks, and 20 weeks followup

  • Handgrip Force variability

    after 20 weeks of training

  • +5 more secondary outcomes

Study Arms (2)

IHG+Hypertension lifestyle guidelines

EXPERIMENTAL

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

Hypertension lifestyle guidelines

NO INTERVENTION

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.

Interventions

IHG home trainingOTHER

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.

IHG+Hypertension lifestyle guidelines

Eligibility Criteria

Age50 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University hospital

Aalborg, Danmark, 9000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29426359DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular 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
Senior researcher, cand. scient., PhD

Study Record Dates

First Submitted

January 13, 2017

First Posted

March 3, 2017

Study Start

March 15, 2017

Primary Completion

July 9, 2020

Study Completion

July 9, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

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

Locations

DK(1)