AgingEXI-AGENCT05571709
The Effect of Exercise on Myokine Production in Aging Persons
A study testing Exercise training, Questionnaire and Percutaneous muscle biopsy in people with Aging and Exercise, run by Hasselt University at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Exercise training, Questionnaire and Percutaneous muscle biopsy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy persons
Who cannot join
- Smoking
- Infection < 2 weeks ago
- Received a vaccine < 2 weeks ago
- Allergy to Lidocain
- Immune deficiency
- Presence of a tumour or in treatment
Show all 12Show fewer
- Usage of anti-coagulant medication
- Presence of following conditions:
- Haemophilia
- Auto-immune disease
- Cardiovascular disease
- Musculoskeletal diseases which refrains the patient from exercising
Trial locations and contacts
1 site in 1 country.
Chiel Hex, MD. contact
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Lena Fonteyn, Drs., +3211269210, lena.fonteyn@uhasselt.be
Leen Slaets, Dr., leen.slaets@uhasselt.be
About this study
Official title: 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.
- Being tested
- Exercise training, Questionnaire, Percutaneous muscle biopsy, Blood sample
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Resistance training of the lower limbs
QuestionnaireBehavioural
Physical activity questionnaire
Percutaneous muscle biopsyProcedure or surgery
Muscle biopsy of the vastus lateralis (m. quadriceps)
Blood sampleProcedure or surgery
Venous blood sample
| Study group | Role | What they receive |
|---|---|---|
| Aged individuals who perform exercise training | Active comparator | Aged individuals will perform an acute bout of resistance trainig (30 minutes). This training is focused on the lower limbs. Receives: Other: Exercise training; Behavioral: Questionnaire; Procedure: Percutaneous muscle biopsy; Procedure: Blood sample |
| Aged individuals who stay sedentary | Sham comparator | Aged individuals will remain seated for 30 minutes. Receives: Behavioral: Questionnaire; Procedure: Percutaneous muscle biopsy; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine concentration
Measurement of multiple cytokines in blood (for example: IL-6, IL-15, IL-4, irisin...) with ELISA's or multiplex assays
Measured: Day 2
Myokine production
Immunohistochemistry staining (fluorescent) of multiple myokines (for example: IL-6, IL-15, IL-4, irisin..) and aging markers (p16,p21...) on muscle tissue
Measured: Day 2
Immune parameters
Flow cytometry panels of immune parameters in muscle tissue
Measured: Day 2
Myokine protein levels
Western blotting of multiple myokines in muscle tissue
Measured: Day 2
Myokine gene expression
Quantitative PCR (polymerase chain reaction) of markers in muscle tissue
Measured: Day 2
Secondary outcomes (3)
Blood pressure
The force of circulating blood on the walls of the arteries. Measured using an electronic sphygmomanometer
Measured: Day 1
Resting Heart Rate
Measured using an electronic sphygmomanometer
Measured: Day 1
International Physical Activity Questionnaire (Short form)
Measures the subjective level of activity of the last seven days. 7 questions regarding amount of time spent on certain activities.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start15 Sep 2022
- Primary completion15 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aged individuals who perform exercise training are compared to aged individuals who remain sedentary.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Hellings, Hasselt University
- Investigators
- Chiel Hex, MD., Principal investigator, University of Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571709
- Sponsor's protocol ID
- B1152022000006
- Acronym
- EXI-AGE
- Status last verified
- Mar 2023
- First submitted
- 5 Oct 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Acute Exercise Bout Increases Soluble and Muscle Myokine Concentration in Healthy, Older Persons
- ClinicalTrials.gov ID
- NCT05571709
- Acronym / sponsor ID
- EXI-AGE / B1152022000006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Aged individuals who perform exercise training are compared to aged individuals who remain sedentary.
| Arm | Type | Receives |
|---|---|---|
| Aged individuals who perform exercise training | Active comparator | Other: Exercise training, Behavioral: Questionnaire, Procedure: Percutaneous muscle biopsy, Procedure: Blood sampleAged individuals will perform an acute bout of resistance trainig (30 minutes). This training is focused on the lower limbs. |
| Aged individuals who stay sedentary | Sham comparator | Behavioral: Questionnaire, Procedure: Percutaneous muscle biopsy, Procedure: Blood sampleAged individuals will remain seated for 30 minutes. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy persons
Key exclusion criteria (12 listed)
- Smoking
- Infection < 2 weeks ago
- Received a vaccine < 2 weeks ago
- Allergy to Lidocain
- Immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingResistance training of the lower limbs | Other | Aged individuals who perform exercise training |
| QuestionnairePhysical activity questionnaire | Behavioural | Aged individuals who perform exercise training, Aged individuals who stay sedentary |
| Percutaneous muscle biopsyMuscle biopsy of the vastus lateralis (m. quadriceps) | Procedure or surgery | Aged individuals who perform exercise training, Aged individuals who stay sedentary |
| Blood sampleVenous blood sample | Procedure or surgery | Aged individuals who perform exercise training, Aged individuals who stay sedentary |
Primary outcome
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
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
Immune parameters
Time frame: Day 2
Flow cytometry panels of immune parameters in muscle tissue
Myokine protein levels
Time frame: Day 2
Western blotting of multiple myokines in muscle tissue
Myokine gene expression
Time frame: Day 2
Quantitative PCR (polymerase chain reaction) of markers in muscle tissue
3 secondary outcomes
Blood pressure
Time frame: Day 1
Resting Heart Rate
Time frame: Day 1
International Physical Activity Questionnaire (Short form)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiel Hex, MD. contact
Chiel Hex, MD. principal investigator
University of Hasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training, Questionnaire and Percutaneous muscle biopsy in people with Aging and Exercise, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bert Op'T Eijnde, Prof. dr. (+3211292121, bert.opteijnde@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine concentration (time frame: Day 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.