- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534049
The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons
The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons - Senior Project Intensive Training (SPRINT)
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
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ivan Bautmans, PhD
- Phone Number: +3224774207
- Email: ivan.bautmans@vub.be
Study Locations
-
-
Brussels
-
Jette, Brussels, Belgium, 1090
- Recruiting
- Vrije Universiteit Brussel
-
Contact:
- Ivan Bautmans, PhD
- Phone Number: +3224774207
- Email: ivan.bautmans@vub.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive strength training (IST)
|
|
Experimental: Strength Endurance training (SET)
|
|
Other: Flexibility training (FT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from Baseline inflammatory profile at 6 weeks
|
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
|
Change from Baseline inflammatory profile at 3 months
|
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
|
Change from Baseline inflammatory profile at 6 months
|
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
|
Change from Baseline inflammatory profile at 9 months
|
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
|
Change from Baseline inflammatory profile at 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FRIA_SPRINT_1
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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