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Agility Training for Older Adults to Improve Fall Risk Factors (AgilE)

Primary Purpose

Age-Related Loss of Skeletal Muscle Mass, Aging, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Agility training
Exercise recommendations
Exercise diary
Sponsored by
Oliver Faude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Loss of Skeletal Muscle Mass

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: willing to be randomized to either arm ability to travel to the sports facility twice a week understanding the german language Exclusion Criteria: smoking, obesity history of cardiovascular, pulmonary or chronic inflammatory disease vision impairments orthopaedic problems preventing them from participating in an exercise program history of osteoporosis or recent low trauma fracture less than two weeks during the intervention period not have taken part in a structured exercise program more than once a week in the past three months

Sites / Locations

  • Departement für Sport, Bewegung und GesundheitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Agility Training

Control

Arm Description

16 weeks, two times per week, 1 hour of multi-component exercise training, exercise guidelines and exercise diary.

Exercise guidelines and exercise diary.

Outcomes

Primary Outcome Measures

Isometric knee-extension strength
Strength in torque (N*m) of the quadriceps femoris muscle. Measured on an isokinetic device in an isometric condition.

Secondary Outcome Measures

Isometric knee-flexion strength
Strength in torque (N*m) of the hamstring muscle group measured on an isokinetic device in an isometric condition.
Cognitive Processing Speed
Eriksen flanker task performance measured be reaction speed in milliseconds and accuracy in percentage.
Cognitive Impulsiveness
Go / No-Go task performance measured by reaction speed in milliseconds and accuracy in percentage.
Balance Performance
Staying as stable as possible during ten seconds in tandem stance eyes open condition. Center of pressure sway path length in mm and average sway speed in m/s is calculated.
Hand Grip Strength
Using a handheld dynamometer with an extended arm squeezing as hard as possible. Measured in N.
Counter movement jump power
Measured on a force plate participants are instructed to jump as high as possible with their hands akimbo. Peak of the time-power curve in Watts.
Blood Pressure
Blood pressure cuff on the right arm at the height of the aorta. Measured in mmHG.
Pulse Wave Velocity
Estimated from a mobile blood pressure cuff (mobil-O-graph) on the right arm. Measured in m/s.
Retinal vessel diameter
A photo is made from the retinal vessels with a static vessel analyzer (camera)through the eye and the vessel diameters are measured in mikrometers.
Quality of Life Questionnaire
26 item questionnaire (WHOQOL-Bref). Every answer is rated on a scale from 1 to 5. Aggregate Score from 0 to 100.
Fall Efficacy
16 item qestionnaire (Fall Efficacy Scale). Every answer is rated on a scale from 1 to 4.
Sleep Disturbances
7 item questionnaire (Insomnia Severity Index). Every answer is rated on a scale from 1 to 5.
Stress
10 item qestionnaire (Perceived Stress Scale). Every answer is rated on a scale from 1 to 5.
Depression
15 item questionnaire (Center for Epidemiological Studies Depression Scale). Every answer is rated on a scale from 1 to 4.

Full Information

First Posted
January 13, 2023
Last Updated
February 3, 2023
Sponsor
Oliver Faude
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1. Study Identification

Unique Protocol Identification Number
NCT05727254
Brief Title
Agility Training for Older Adults to Improve Fall Risk Factors
Acronym
AgilE
Official Title
Agility Training for Older Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oliver Faude

4. Oversight

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

5. Study Description

Brief Summary
In this randomized controlled trial the effect of 4 months of multi-component (strength, balance, cognition, endurance) exercise training intervention on measures of neuromuscular performance, cognition, and endurance as well as neural adaptations on a central and peripheral level is investigated. 40 subjects are recruited that are generally health and between 60 and 80 years of age. The interventions is based around exercises, where different tasks have to be solved simultaneously rather than serially, as has previously been done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Loss of Skeletal Muscle Mass, Aging, Sarcopenia, Cognitive Decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with an intervention and a control arm.
Masking
None (Open Label)
Masking Description
Due to the nature of the study (exercise intervention) no masking of participants and intervention providers is possible.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Agility Training
Arm Type
Experimental
Arm Description
16 weeks, two times per week, 1 hour of multi-component exercise training, exercise guidelines and exercise diary.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Exercise guidelines and exercise diary.
Intervention Type
Behavioral
Intervention Name(s)
Agility training
Intervention Description
Multi-component (strength, balance, cognition) exercise training.
Intervention Type
Behavioral
Intervention Name(s)
Exercise recommendations
Intervention Description
Participants are being given the standard recommendations how much exercise and what type older adults should do.
Intervention Type
Behavioral
Intervention Name(s)
Exercise diary
Intervention Description
Participants are instructed to write down their physical activity and exercises.
Primary Outcome Measure Information:
Title
Isometric knee-extension strength
Description
Strength in torque (N*m) of the quadriceps femoris muscle. Measured on an isokinetic device in an isometric condition.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Isometric knee-flexion strength
Description
Strength in torque (N*m) of the hamstring muscle group measured on an isokinetic device in an isometric condition.
Time Frame
16 weeks
Title
Cognitive Processing Speed
Description
Eriksen flanker task performance measured be reaction speed in milliseconds and accuracy in percentage.
Time Frame
16 weeks
Title
Cognitive Impulsiveness
Description
Go / No-Go task performance measured by reaction speed in milliseconds and accuracy in percentage.
Time Frame
16 weeks
Title
Balance Performance
Description
Staying as stable as possible during ten seconds in tandem stance eyes open condition. Center of pressure sway path length in mm and average sway speed in m/s is calculated.
Time Frame
16 weeks
Title
Hand Grip Strength
Description
Using a handheld dynamometer with an extended arm squeezing as hard as possible. Measured in N.
Time Frame
16 weeks
Title
Counter movement jump power
Description
Measured on a force plate participants are instructed to jump as high as possible with their hands akimbo. Peak of the time-power curve in Watts.
Time Frame
16 weeks
Title
Blood Pressure
Description
Blood pressure cuff on the right arm at the height of the aorta. Measured in mmHG.
Time Frame
16 weeks
Title
Pulse Wave Velocity
Description
Estimated from a mobile blood pressure cuff (mobil-O-graph) on the right arm. Measured in m/s.
Time Frame
16 weeks
Title
Retinal vessel diameter
Description
A photo is made from the retinal vessels with a static vessel analyzer (camera)through the eye and the vessel diameters are measured in mikrometers.
Time Frame
16 weeks
Title
Quality of Life Questionnaire
Description
26 item questionnaire (WHOQOL-Bref). Every answer is rated on a scale from 1 to 5. Aggregate Score from 0 to 100.
Time Frame
16 weeks
Title
Fall Efficacy
Description
16 item qestionnaire (Fall Efficacy Scale). Every answer is rated on a scale from 1 to 4.
Time Frame
16 weeks
Title
Sleep Disturbances
Description
7 item questionnaire (Insomnia Severity Index). Every answer is rated on a scale from 1 to 5.
Time Frame
16 weeks
Title
Stress
Description
10 item qestionnaire (Perceived Stress Scale). Every answer is rated on a scale from 1 to 5.
Time Frame
16 weeks
Title
Depression
Description
15 item questionnaire (Center for Epidemiological Studies Depression Scale). Every answer is rated on a scale from 1 to 4.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Corticospinal Inhibition
Description
Difference between paired and single pulse motor evoked potential by transcranial magnetic stimulation.
Time Frame
16 weeks
Title
Voluntary activation
Description
Degree of ability to contract the soleus muscle voluntarily.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: willing to be randomized to either arm ability to travel to the sports facility twice a week understanding the german language Exclusion Criteria: smoking, obesity history of cardiovascular, pulmonary or chronic inflammatory disease vision impairments orthopaedic problems preventing them from participating in an exercise program history of osteoporosis or recent low trauma fracture less than two weeks during the intervention period not have taken part in a structured exercise program more than once a week in the past three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Lichtenstein, MSc
Phone
+41796415225
Email
e.lichtenstein@unibas.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Faude, Prof. Dr.
Phone
+41612074735
Email
oliver.faude@unibas.ch
Facility Information:
Facility Name
Departement für Sport, Bewegung und Gesundheit
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4052
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lichtenstein, MSc
Phone
0796415225
Email
e.lichtenstein@unibas.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication of the raw data along the publication of the results. Data is anonymized. Outcome results of the individual tests are shared.
IPD Sharing Time Frame
End of 2023
IPD Sharing Access Criteria
Open Access

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Agility Training for Older Adults to Improve Fall Risk Factors

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