NCT05727254

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 13, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

January 13, 2023

Last Update Submit

March 31, 2025

Conditions

Age-Related Loss of Skeletal Muscle MassAgingSarcopeniaCognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Isometric knee-extension strength

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

    16 weeks

Secondary Outcomes (14)

  • Isometric knee-flexion strength

    16 weeks

  • Cognitive Processing Speed

    16 weeks

  • Cognitive Impulsiveness

    16 weeks

  • Balance Performance

    16 weeks

  • Hand Grip Strength

    16 weeks

  • +9 more secondary outcomes

Other Outcomes (2)

  • Corticospinal Inhibition

    16 weeks

  • Voluntary activation

    16 weeks

Study Arms (2)

Agility Training

EXPERIMENTAL

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

Behavioral: Agility trainingBehavioral: Exercise recommendationsBehavioral: Exercise diary

Control

ACTIVE COMPARATOR

Exercise guidelines and exercise diary.

Behavioral: Exercise recommendationsBehavioral: Exercise diary

Interventions

Agility trainingBEHAVIORAL

Multi-component (strength, balance, cognition) exercise training.

Agility Training
Exercise recommendationsBEHAVIORAL

Participants are being given the standard recommendations how much exercise and what type older adults should do.

Agility TrainingControl
Exercise diaryBEHAVIORAL

Participants are instructed to write down their physical activity and exercises.

Agility TrainingControl

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • willing to be randomized to either arm
  • ability to travel to the sports facility twice a week
  • understanding the german language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement für Sport, Bewegung und Gesundheit

Basel, Canton of Basel-City, 4052, Switzerland

Location

MeSH Terms

Conditions

SarcopeniaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the study (exercise intervention) no masking of participants and intervention providers is possible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with an intervention and a control arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 14, 2023

Study Start

July 13, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Publication of the raw data along the publication of the results. Data is anonymized. Outcome results of the individual tests are shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
End of 2023
Access Criteria
Open Access

Locations

CH(1)