- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727254
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Agility Training
16 weeks, two times per week, 1 hour of multi-component exercise training, exercise guidelines and exercise diary.
|
Multi-component (strength, balance, cognition) exercise training.
Participants are being given the standard recommendations how much exercise and what type older adults should do.
Participants are instructed to write down their physical activity and exercises.
|
|
Active Comparator: Control
Exercise guidelines and exercise diary.
|
Participants are being given the standard recommendations how much exercise and what type older adults should do.
Participants are instructed to write down their physical activity and exercises.
|
What is the study measuring?
Primary Outcome Measures
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
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
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
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)
July 13, 2022
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
January 13, 2023
First Submitted That Met QC Criteria
February 3, 2023
First Posted (Actual)
February 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2025
Last Update Submitted That Met QC Criteria
March 31, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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