NCT04019132

Brief Summary

The primary aim of this study is to optimize the methodology to measure lower limb power in older adults, so that clinicians are able to detect functional problems in this population earlier.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

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

July 2, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

July 2, 2019

Last Update Submit

May 18, 2022

Conditions

Aging

Keywords

Muscle PowerFunctional capacity

Outcome Measures

Primary Outcomes (8)

  • Lower limb muscle power during a stair climb test

    The power (watt) needed to perform stair climbing is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Lower limb muscle power during a sit-to-stand test

    The power (watt) needed to perform 5 sit-to-stand transitions and a 30 sec. sit-to-stand test is calculated using a 3D accelerometer (DynaPort MoveTest, McRoberts), worn at the back of the participant

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Reliability of power measurements measured with a 3D accelerometer

    Reliability of power measurements (watt) measured with a 3D accelerometer (DynaPort MoveTest, McRoberts) worn during functional activities (stair climbing, sit-to-stand test) three times within a period of 2 weeks

    1 test moment of approximately 30 minutes, planned between September 2019 and July 2020

  • Rate of power (force-velocity) development

    Participants perform a test protocol on a Biodex Dynamometer. The rate of power development (watt/s) is defined as the linear slope of the power-time curve and is measured from the onset of movement till peak power.

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Handgrip strength

    Handgrip strength (kg) evaluated with a Jamar dynamometer

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Jumping height

    Jumping height (in cm) measured during a standardized jump test

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Physical activity

    Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry

    1 week

  • Number of steps/stairs a day

    Objective measurement of physical activity in a subgroup of older participants (n=50) by means of accelerometry

    1 week

Secondary Outcomes (7)

  • Number of repetitions during a 30s sit-to-stand test

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • 6min walk distance

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Balance

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Maximal gait speed

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • Usual gait speed

    1 test moment of approximately 1 hour, planned between September 2019 and July 2020

  • +2 more secondary outcomes

Study Arms (4)

Older adults

Older adults aged \>65 years

Diagnostic Test: Muscle function test

Young group

Younger adults between the age of 20 and 40 years

Diagnostic Test: Muscle function test

Middle-aged group 1

Adults between the age of 40 and 55 years

Diagnostic Test: Muscle function test

Middle-aged group 2

Adults between the age of 55 and 65 years

Diagnostic Test: Muscle function test

Interventions

Muscle function testDIAGNOSTIC_TEST

Body measurements, power and strength tests of the knee extensor muscle, handgrip strength, functional capacity tests, objective measurement of physical activity (subgroup of older adults, n=50)

Middle-aged group 1Middle-aged group 2Older adultsYoung group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy young to older adults

You may qualify if:

  • Age \>20

You may not qualify if:

  • Unstable cardiovascular diseases
  • Fever or acute infection
  • Cognitive or physical malfunctioning that hinders the understanding or performance of tests and/or instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven - Department of Movement Sciences

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 15, 2019

Study Start

January 20, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)