NCT05571709

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

October 5, 2022

Last Update Submit

March 29, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Cytokine concentration

    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

    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

    Flow cytometry panels of immune parameters in muscle tissue

    Day 2

  • Myokine protein levels

    Western blotting of multiple myokines in muscle tissue

    Day 2

  • Myokine gene expression

    Quantitative PCR (polymerase chain reaction) of markers in muscle tissue

    Day 2

Secondary Outcomes (3)

  • Blood pressure

    Day 1

  • Resting Heart Rate

    Day 1

  • International Physical Activity Questionnaire (Short form)

    Day 1

Study Arms (2)

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.

Other: Exercise trainingBehavioral: QuestionnaireProcedure: Percutaneous muscle biopsyProcedure: Blood sample

Aged individuals who stay sedentary

SHAM COMPARATOR

Aged individuals will remain seated for 30 minutes.

Behavioral: QuestionnaireProcedure: Percutaneous muscle biopsyProcedure: Blood sample

Interventions

Resistance training of the lower limbs

Aged individuals who perform exercise training
QuestionnaireBEHAVIORAL

Physical activity questionnaire

Aged individuals who perform exercise trainingAged individuals who stay sedentary

Muscle biopsy of the vastus lateralis (m. quadriceps)

Aged individuals who perform exercise trainingAged individuals who stay sedentary
Blood samplePROCEDURE

Venous blood sample

Aged individuals who perform exercise trainingAged individuals who stay sedentary

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy persons

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseSurveys and QuestionnairesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Officials

  • Chiel Hex, MD.

    University of Hasselt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bert Op'T Eijnde, Prof. dr.

CONTACT

Chiel Hex, MD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Aged individuals who perform exercise training are compared to aged individuals who remain sedentary.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

September 15, 2022

Primary Completion

October 15, 2023

Study Completion

December 31, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations