Mild Cognitive Impairment (MCI)NCT06682741
Comparison of Different Training Programs on Cognitive Function
A study testing Exercise in people with Mild Cognitive Impairment (MCI), run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The goal of the project is to identify the most effective exercise modalities in terms of neuroprotective effects and FP improvement. Hypothesis: Dancing will increase BDNF, GDNF and CLU levels to a greater extent than traditional forms of AF, resulting in significantly greater improvements in FP in subjects aged ≥ 60… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 17 Sep 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women
Who cannot join
- previous diagnoses of cardiovascular diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Different Training Programs on the Levels of Cognitive Function
The goal of the project is to identify the most effective exercise modalities in terms of neuroprotective effects and FP improvement.
Hypothesis: Dancing will increase BDNF, GDNF and CLU levels to a greater extent than traditional forms of AF, resulting in significantly greater improvements in FP in subjects aged ≥ 60 years. The study will involve 60 women aged ≥ 60 years, randomly and equitably assigned to training groups (i.e., resistance training using body weight, dance) and a control group (i.e., a group of physically inactive women).
Read more
Methodology:
Participants: 60 women aged ≥ 60 randomly and equally assigned to training groups (Dance and Resistance training) and a control group (i.e., physically inactive women)
Scientists will compare the impact of different forms of physical activity on cognitive functions
Read the detailed description
The training interventions will last 6 months. The intensity of physical activity will be determined as a percentage of maximum heart rate (HRmax), assessed based on a fitness test (Chester Step Test), using data from mobile devices monitoring physical activity. Cognitive function (CF) levels, and the concentrations of GDNF, BDNF, and CLU, as well as the Chester Step Test, will be evaluated twice: once at baseline and once after the training programs. Blood samples for measuring neurotrophin and CLU levels will be collected in the morning, after an overnight fast (approximately 12 hours since the last meal). The concentrations of neurotrophins and CLU will be measured using the ELISA method. CF will be assessed using standardized and validated neuropsychological tests.
Expected Outcomes: Greater improvement in CF in the dance group compared to the resistance training and control groups, with higher levels of BDNF, GDNF, and CLU in the dance group.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Exercise
- Keywords
- physical activity, neurotrophins, neuroprotection, cognitive function, MCI
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
supervised exercise training; twice a week for 12 months
| Study group | Role | What they receive |
|---|---|---|
| excercise | Experimental | supervised exercise training; twice a week for 12 months Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
tle level of cognitive functions
Cognitive functioning is assessed using the standardized MoCA test, which has a maximum score of 30 points. A score of 26 or higher is considered normal
Measured: before and after 12 months of interventions
Secondary outcomes (1)
blood markers
Neurotrophins, such as BDNF (Brain-Derived Neurotrophic Factor) and GDNF (Glial-Derived Neurotrophic Factor), as well as clusterin are measured from blood using an ELISA test kit
Measured: before and after 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start17 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Ratajczak, PhD, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682741
- Sponsor's protocol ID
- 433/24
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Training Programs on the Levels of Cognitive Function
- ClinicalTrials.gov ID
- NCT06682741
- Acronym / sponsor ID
- 433/24
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- physical activity, neurotrophins, neuroprotection, cognitive function, MCI
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
The goal of the project is to identify the most effective exercise modalities in terms of neuroprotective effects and FP improvement.
Hypothesis: Dancing will increase BDNF, GDNF and CLU levels to a greater extent than traditional forms of AF, resulting in significantly greater improvements in FP in subjects aged ≥ 60 years. The study will involve 60 women aged ≥ 60 years, randomly and equitably assigned to training groups (i.e., resistance training using body weight, dance) and a control group (i.e., a group of physically inactive women).
Methodology:
Participants: 60 women aged ≥ 60 randomly and equally assigned to training groups (Dance and Resistance training) and a control group (i.e., physically inactive women)
Scientists will compare the impact of different forms of physical activity on cognitive functions
Detailed description
The training interventions will last 6 months. The intensity of physical activity will be determined as a percentage of maximum heart rate (HRmax), assessed based on a fitness test (Chester Step Test), using data from mobile devices monitoring physical activity. Cognitive function (CF) levels, and the concentrations of GDNF, BDNF, and CLU, as well as the Chester Step Test, will be evaluated twice: once at baseline and once after the training programs. Blood samples for measuring neurotrophin and CLU levels will be collected in the morning, after an overnight fast (approximately 12 hours since the last meal). The concentrations of neurotrophins and CLU will be measured using the ELISA method. CF will be assessed using standardized and validated neuropsychological tests.
Expected Outcomes: Greater improvement in CF in the dance group compared to the resistance training and control groups, with higher levels of BDNF, GDNF, and CLU in the dance group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| excercise | Experimental | Other: Exercisesupervised exercise training; twice a week for 12 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women
Key exclusion criteria (1 listed)
- previous diagnoses of cardiovascular diseases
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 |
|---|---|---|
| Exercisesupervised exercise training; twice a week for 12 months | Other | excercise |
Primary outcome
tle level of cognitive functions
Time frame: before and after 12 months of interventions
Cognitive functioning is assessed using the standardized MoCA test, which has a maximum score of 30 points. A score of 26 or higher is considered normal
1 secondary outcome
blood markers
Time frame: before and after 12 months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Joanna Ratajczak, PhD study director
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Mild Cognitive Impairment (MCI), run by Poznan University of Physical Education at 1 site in Poland.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 12 Nov 2024. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tle level of cognitive functions (time frame: before and after 12 months of interventions). 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 12 Nov 2024.