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The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons

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ClinicalTrials.gov Identifier: NCT04534049
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Ivan Bautmans, Vrije Universiteit Brussel

Study Description
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Brief Summary:

This study aims to identify the mechanisms by which physical exercise can counter inflammation and improve immune function in older persons. These mechanisms will be investigated to develop exercise-based/derived strategies to improve recovery of older patients suffering from immunosenescence and/or immune suppression.

In this randomized controlled trial, the effects of resistance exercise (RE) on inflammation and chronic low-grade inflammation (CLIP) will be investigated.

The investigators expect that exercise-induced changes in immunosenescence will be reflected by changes in the various domains of interest: 1) the expression of immunosenescence-related genes in PMBC, in circulating markers of inflammation and in PMBC behaviour following LPS stimulation, 2) the proportion of circulating PMBC showing surface and/or intracellular markers for cell senescence, and 3) markers reflecting alterations at the level of the extracellular matrix.

Additionally, the investigators want to verify whether 1) resistance exercise improves inflammation and immunosenescence in skin tissue, and 2) resistance exercise improves the stress response in skin tissue after an in-vivo inflammatory challenge by saline injection.

The results of this project will allow us to provide new insights in the complex interaction between physical exercise and immunosenescence as well as to present evidence-based guidelines for exercise in elderly persons to counter CLIP


Condition or disease Intervention/treatment Phase
Healthy Aged Volunteers Other: Intensive Strength Training (IST) Other: Strength Endurance Training (SET) Other: Flexibility Training (FT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
Official Title: The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons - Senior Project Intensive Training (SPRINT)
Actual Study Start Date : December 2011
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intensive strength training (IST) Other: Intensive Strength Training (IST)
Experimental: Strength Endurance training (SET) Other: Strength Endurance Training (SET)
Flexibility training (FT) Other: Flexibility Training (FT)


Outcome Measures
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Primary Outcome Measures :
  1. Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile [ Time Frame: Change from Baseline inflammatory profile at 6 weeks ]
    The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells

  2. Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile [ Time Frame: Change from Baseline inflammatory profile at 3 months ]
    The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells

  3. Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile [ Time Frame: Change from Baseline inflammatory profile at 6 months ]
    The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells

  4. Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile [ Time Frame: Change from Baseline inflammatory profile at 9 months ]
    The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells

  5. Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile [ Time Frame: Change from Baseline inflammatory profile at 12 months ]
    The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged people (male or female) living independently in the community;
  • Aged ≥65yrs.

Exclusion Criteria:

  • Performing currently or within the past six months on a regular basis physical exercise at higher intensities than habitual daily activity (e.g. fitness classes, strengthening exercises, cycling club);
  • Presenting contra-indications for any of the exercise interventions;
  • Cognitive impairment (unable to understand or execute the test/exercise instructions due to cognitive impairment (MMSE<24/30));
  • Presenting physical disability;
  • Using anti-inflammatory and/or immunosuppressive medication
  • Presenting an acute inflammatory condition (CRP >10mg/L)

Exclusion Criteria for dermatology part:

  • use of medications that cannot be temporarily interrupted for this study:

    • medication that suppresses allergic reaction,
    • Anticoagulation,
    • Treatment with cortisone creams, calcineurin inhibitor creams (Elidel, Protopic) within 7 days before the first visit,
    • Treatment with the following medication within 5 half-lives for the first visit: systemic immunosuppressive / immunomodulating medications (e.g. methotrexate (Ledertrexat), cyclosporine (Neoral), azathioprine (Imuran), mycomofetil phenolate (Cellcept)), Cortisone tablets (eg Medrol) (except use of cortisone in the form of nasal spray, puffer, eye drops), Targeted biological treatment (monoclonal antibodies or inhibitors, eg Dupixent),
  • undergoing or have undergone allergen-specific immunotherapy,
  • participating in another interventional clinical study for atopic dermatitis,
  • showing inflammatory skin diseases (e.g. atopic eczema, psoriasis).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534049


Contacts
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Contact: Ivan Bautmans, PhD +3224774207 ivan.bautmans@vub.be

Locations
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Belgium
Vrije Universiteit Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Ivan Bautmans, PhD    +3224774207    ivan.bautmans@vub.be   
Sponsors and Collaborators
Vrije Universiteit Brussel
More Information
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Responsible Party: Prof. Ivan Bautmans, Prof. dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT04534049    
Other Study ID Numbers: FRIA_SPRINT_1
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Keywords provided by Prof. Ivan Bautmans, Vrije Universiteit Brussel:
Aged people
Exercises
Resistance exercise
Flexibility training
Inflammation