- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05571709
The Effect of Exercise on Myokine Production in Aging Persons (EXI-AGE)
March 29, 2023 updated by: Niels Hellings, Hasselt University
Does an Acute Exercise Bout Increases Soluble and Muscle Myokine Concentration in Healthy, Older Persons
The incidence of age-related diseases, such as cancer and cardiovascular diseases, rapidly rises.
These days, age-related diseases cause the majority of all healthcare expenses.
During ageing senescent cells secrete a range of harmful inflammatory signals, which leads to chronic inflammation (inflamm-aging) and accelerates aging throughout the rest of the body.
Interestingly, people who regularly exercise show less signs of inflamm-aging compared to people with a sedentary lifestyle.
Molecules secreted by skeletal muscles, called myokines, may play an important role.
However, the underlying molecular mechanisms remain unknown.
This pilot study aims to investigate if an acute bout of resistance training is an appropriate tool to induce an increase in the release of muscle derived myokines in aged persons.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
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 Contact
- Name: Bert Op'T Eijnde, Prof. dr.
- Phone Number: +3211292121
- Email: bert.opteijnde@uhasselt.be
Study Contact Backup
- Name: Chiel Hex, MD.
- Email: chiel.hex@uhasselt.be
Study Locations
-
-
Limburg
-
Diepenbeek, Limburg, Belgium, 3590
- Recruiting
- Hasselt University
-
Contact:
- Lena Fonteyn, Drs.
- Phone Number: +3211269210
- Email: lena.fonteyn@uhasselt.be
-
Contact:
- Leen Slaets, Dr.
- Email: leen.slaets@uhasselt.be
-
-
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
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy persons
Exclusion Criteria:
- Smoking
- Infection < 2 weeks ago
- Received a vaccine < 2 weeks ago
- Allergy to Lidocain
- Immune deficiency
- Presence of a tumour or in treatment
- Usage of anti-coagulant medication
Presence of following conditions:
- Haemophilia
- Auto-immune disease
- Cardiovascular disease
- Musculoskeletal diseases which refrains the patient from exercising
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Aged individuals who perform exercise training
Aged individuals will perform an acute bout of resistance trainig (30 minutes).
This training is focused on the lower limbs.
|
Resistance training of the lower limbs
Physical activity questionnaire
Muscle biopsy of the vastus lateralis (m.
quadriceps)
Venous blood sample
|
|
Sham Comparator: Aged individuals who stay sedentary
Aged individuals will remain seated for 30 minutes.
|
Physical activity questionnaire
Muscle biopsy of the vastus lateralis (m.
quadriceps)
Venous blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cytokine concentration
Time Frame: Day 2
|
Measurement of multiple cytokines in blood (for example: IL-6, IL-15, IL-4, irisin...) with ELISA's or multiplex assays
|
Day 2
|
|
Myokine production
Time Frame: Day 2
|
Immunohistochemistry staining (fluorescent) of multiple myokines (for example: IL-6, IL-15, IL-4, irisin..) and aging markers (p16,p21...) on muscle tissue
|
Day 2
|
|
Immune parameters
Time Frame: Day 2
|
Flow cytometry panels of immune parameters in muscle tissue
|
Day 2
|
|
Myokine protein levels
Time Frame: Day 2
|
Western blotting of multiple myokines in muscle tissue
|
Day 2
|
|
Myokine gene expression
Time Frame: Day 2
|
Quantitative PCR (polymerase chain reaction) of markers in muscle tissue
|
Day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Day 1
|
The force of circulating blood on the walls of the arteries.
Measured using an electronic sphygmomanometer
|
Day 1
|
|
Resting Heart Rate
Time Frame: Day 1
|
Measured using an electronic sphygmomanometer
|
Day 1
|
|
International Physical Activity Questionnaire (Short form)
Time Frame: Day 1
|
Measures the subjective level of activity of the last seven days.
7 questions regarding amount of time spent on certain activities.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chiel Hex, MD., University of Hasselt
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)
September 15, 2022
Primary Completion (Anticipated)
October 15, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
October 5, 2022
First Submitted That Met QC Criteria
October 6, 2022
First Posted (Actual)
October 7, 2022
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 29, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- B1152022000006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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