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

March 31, 2025 updated by: Oliver Faude

Agility Training for Older Adults: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4052
        • Departement für Sport, Bewegung und Gesundheit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Agility Training
16 weeks, two times per week, 1 hour of multi-component exercise training, exercise guidelines and exercise diary.
Behavioral: Agility training
Multi-component (strength, balance, cognition) exercise training.
Behavioral: Exercise recommendations
Participants are being given the standard recommendations how much exercise and what type older adults should do.
Behavioral: Exercise diary
Participants are instructed to write down their physical activity and exercises.
Active Comparator: Control
Exercise guidelines and exercise diary.
Behavioral: Exercise recommendations
Participants are being given the standard recommendations how much exercise and what type older adults should do.
Behavioral: Exercise diary
Participants are instructed to write down their physical activity and exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isometric knee-extension strength
Time Frame: 16 weeks
Strength in torque (N*m) of the quadriceps femoris muscle. Measured on an isokinetic device in an isometric condition.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isometric knee-flexion strength
Time Frame: 16 weeks
Strength in torque (N*m) of the hamstring muscle group measured on an isokinetic device in an isometric condition.
16 weeks
Cognitive Processing Speed
Time Frame: 16 weeks
Eriksen flanker task performance measured be reaction speed in milliseconds and accuracy in percentage.
16 weeks
Cognitive Impulsiveness
Time Frame: 16 weeks
Go / No-Go task performance measured by reaction speed in milliseconds and accuracy in percentage.
16 weeks
Balance Performance
Time Frame: 16 weeks
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.
16 weeks
Hand Grip Strength
Time Frame: 16 weeks
Using a handheld dynamometer with an extended arm squeezing as hard as possible. Measured in N.
16 weeks
Counter movement jump power
Time Frame: 16 weeks
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.
16 weeks
Blood Pressure
Time Frame: 16 weeks
Blood pressure cuff on the right arm at the height of the aorta. Measured in mmHG.
16 weeks
Pulse Wave Velocity
Time Frame: 16 weeks
Estimated from a mobile blood pressure cuff (mobil-O-graph) on the right arm. Measured in m/s.
16 weeks
Retinal vessel diameter
Time Frame: 16 weeks
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.
16 weeks
Quality of Life Questionnaire
Time Frame: 16 weeks
26 item questionnaire (WHOQOL-Bref). Every answer is rated on a scale from 1 to 5. Aggregate Score from 0 to 100.
16 weeks
Fall Efficacy
Time Frame: 16 weeks
16 item qestionnaire (Fall Efficacy Scale). Every answer is rated on a scale from 1 to 4.
16 weeks
Sleep Disturbances
Time Frame: 16 weeks
7 item questionnaire (Insomnia Severity Index). Every answer is rated on a scale from 1 to 5.
16 weeks
Stress
Time Frame: 16 weeks
10 item qestionnaire (Perceived Stress Scale). Every answer is rated on a scale from 1 to 5.
16 weeks
Depression
Time Frame: 16 weeks
15 item questionnaire (Center for Epidemiological Studies Depression Scale). Every answer is rated on a scale from 1 to 4.
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corticospinal Inhibition
Time Frame: 16 weeks
Difference between paired and single pulse motor evoked potential by transcranial magnetic stimulation.
16 weeks
Voluntary activation
Time Frame: 16 weeks
Degree of ability to contract the soleus muscle voluntarily.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oliver Faude

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2222-00145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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