Healthy Aged VolunteersNCT04534049
The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons
A study testing Intensive Strength Training (IST), Strength Endurance Training (SET) and Flexibility Training (FT) in people with Healthy Aged Volunteers, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aged Volunteers
- What is being tested?
- Intensive Strength Training (IST), Strength Endurance Training (SET) and Flexibility Training (FT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged people (male or female) living independently in the community;
- Aged ≥65yrs.
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Vrije Universiteit Brussel
Jette, Brussels Capital, 1090
Ivan Bautmans, PhD, +3224774207, ivan.bautmans@vub.be
About this study
Official title: 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.
Read more
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
- Conditions
- Healthy Aged Volunteers
- Being tested
- Intensive Strength Training (IST), Strength Endurance Training (SET), Flexibility Training (FT)
- Keywords
- Aged people, Exercises, Resistance exercise, Flexibility training, Inflammation
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Strength Training (IST)Other
Strength Endurance Training (SET)Other
Flexibility Training (FT)Other
| Study group | Role | What they receive |
|---|---|---|
| Intensive strength training (IST) | Experimental | Not described Receives: Other: Intensive Strength Training (IST) |
| Strength Endurance training (SET) | Experimental | Not described Receives: Other: Strength Endurance Training (SET) |
| Flexibility training (FT) | Other | Not described Receives: Other: Flexibility Training (FT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood of older adults will be investigated by qPCR to reveal changes in the inflammatory profile
The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells
Measured: 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
The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells
Measured: 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
The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells
Measured: 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
The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells
Measured: 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
The primary objective is to investigate the effects of strength training on inflammation- and immunosenescence-related genes in peripheral blood mononuclear cells
Measured: Change from Baseline inflammatory profile at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study startDec 2011
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Aged VolunteersStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Ivan Bautmans, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534049
- Sponsor's protocol ID
- FRIA_SPRINT_1
- Status last verified
- Jan 2022
- First submitted
- 3 Jul 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Types of Physical Exercise on Immunosenescence in Elderly Persons - Senior Project Intensive Training (SPRINT)
- ClinicalTrials.gov ID
- NCT04534049
- Acronym / sponsor ID
- FRIA_SPRINT_1
- Conditions
- Healthy Aged Volunteers
- Keywords
- Aged people, Exercises, Resistance exercise, Flexibility training, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2020 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive strength training (IST) | Experimental | Other: Intensive Strength Training (IST) |
| Strength Endurance training (SET) | Experimental | Other: Strength Endurance Training (SET) |
| Flexibility training (FT) | Other | Other: Flexibility Training (FT) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged people (male or female) living independently in the community;
- Aged ≥65yrs.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Intensive Strength Training (IST) | Other | Intensive strength training (IST) |
| Strength Endurance Training (SET) | Other | Strength Endurance training (SET) |
| Flexibility Training (FT) | Other | Flexibility training (FT) |
Primary outcome
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Strength Training (IST), Strength Endurance Training (SET) and Flexibility Training (FT) in people with Healthy Aged Volunteers, run by Vrije Universiteit Brussel 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 2 inclusion and 14 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 26 Jan 2022. 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. 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 Ivan Bautmans, PhD (+3224774207, ivan.bautmans@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 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 26 Jan 2022.