Clinical trial NCT04534049: The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons
Official title: The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons - Senior Project Intensive Training (SPRINT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Aged Volunteers
Keywords: Aged people
Exercises
Resistance exercise
Flexibility training
Inflammation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility 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).

Primary outcomes:
measure: Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile
timeFrame: Change from Baseline inflammatory profile at 6 weeks
measure: Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile
timeFrame: Change from Baseline inflammatory profile at 3 months
measure: Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile
timeFrame: Change from Baseline inflammatory profile at 6 months
measure: Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile
timeFrame: Change from Baseline inflammatory profile at 9 months
measure: Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile
timeFrame: Change from Baseline inflammatory profile at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Vrije Universiteit Brussel
state: Brussels
Study officials:
References: