AgilE: Agility Training for Older Adults to Improve Fall Risk Factors

Sponsor
Oliver Faude (Other)
Overall Status
Recruiting
CT.gov ID
NCT05727254
Collaborator
(none)
40
1
2
16.6
2.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Agility training
  • Behavioral: Exercise recommendations
  • Behavioral: Exercise diary
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial with an intervention and a control arm.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.
Primary Purpose:
Treatment
Official Title:
Agility Training for Older Adults: A Randomized Controlled Trial
Actual Study Start Date :
Jul 13, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Isometric knee-extension strength [16 weeks]

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

Secondary Outcome Measures

  1. Isometric knee-flexion strength [16 weeks]

    Strength in torque (N*m) of the hamstring muscle group measured on an isokinetic device in an isometric condition.

  2. Cognitive Processing Speed [16 weeks]

    Eriksen flanker task performance measured be reaction speed in milliseconds and accuracy in percentage.

  3. Cognitive Impulsiveness [16 weeks]

    Go / No-Go task performance measured by reaction speed in milliseconds and accuracy in percentage.

  4. Balance Performance [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.

  5. Hand Grip Strength [16 weeks]

    Using a handheld dynamometer with an extended arm squeezing as hard as possible. Measured in N.

  6. Counter movement jump power [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.

  7. Blood Pressure [16 weeks]

    Blood pressure cuff on the right arm at the height of the aorta. Measured in mmHG.

  8. Pulse Wave Velocity [16 weeks]

    Estimated from a mobile blood pressure cuff (mobil-O-graph) on the right arm. Measured in m/s.

  9. Retinal vessel diameter [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.

  10. Quality of Life Questionnaire [16 weeks]

    26 item questionnaire (WHOQOL-Bref). Every answer is rated on a scale from 1 to 5. Aggregate Score from 0 to 100.

  11. Fall Efficacy [16 weeks]

    16 item qestionnaire (Fall Efficacy Scale). Every answer is rated on a scale from 1 to 4.

  12. Sleep Disturbances [16 weeks]

    7 item questionnaire (Insomnia Severity Index). Every answer is rated on a scale from 1 to 5.

  13. Stress [16 weeks]

    10 item qestionnaire (Perceived Stress Scale). Every answer is rated on a scale from 1 to 5.

  14. Depression [16 weeks]

    15 item questionnaire (Center for Epidemiological Studies Depression Scale). Every answer is rated on a scale from 1 to 4.

Other Outcome Measures

  1. Corticospinal Inhibition [16 weeks]

    Difference between paired and single pulse motor evoked potential by transcranial magnetic stimulation.

  2. Voluntary activation [16 weeks]

    Degree of ability to contract the soleus muscle voluntarily.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departement für Sport, Bewegung und Gesundheit Basel Basel-Stadt Switzerland 4052

Sponsors and Collaborators

  • Oliver Faude

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oliver Faude, Prof. Dr., University of Basel
ClinicalTrials.gov Identifier:
NCT05727254
Other Study ID Numbers:
  • 2222-00145
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023