Mild Cognitive ImpairmentEPAC-MNCT01553929
Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient
A study testing Physical Training and cognitive activity (EPC group) and Physical training (EP group) in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Regular physical activity is now recognized as a key element of good physical and mental health and this all ages. MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Physical Training and cognitive activity (EPC group) and Physical training (EP group)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jan 2015
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed patient MCI (Mild Cognitive Impairment)
- Elderly from 40 to 75 years old
- MMSE upper to 22
- Affiliated or beneficiary of a national insurance scheme
- Medical capacity to the physical proposed activity (filling of the conditions of the Medical certificate of not contraindication in the sport)
Who cannot join
- The placed persons under guardianship, under protection of justice,
- The private persons of freedom (administrative or judicial)
- Nobody already participating in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Trainig and Cognitive Activity on the MCI Patient
Regular physical activity is now recognized as a key element of good physical and mental health and this all ages.
MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI).
Read more
DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group.
In agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. Furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Physical Training and cognitive activity (EPC group), Physical training (EP group), control group
- Keywords
- MCI
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Training and cognitive activity (EPC group)Other
The patients of the EPC group will realize 2 weekly sessions of 20 minutes of pédalage. During the exercise, the patients will realize a series of tests of decision-making and perceptive cognitive capacity.
Physical training (EP group)Other
The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
control groupOther
no physical training and no cognitive activity
| Study group | Role | What they receive |
|---|---|---|
| Physical and cognitive activity group | Experimental | Not described Receives: Other: Physical Training and cognitive activity (EPC group) |
| Physical activity group | Active comparator | Not described Receives: Other: Physical training (EP group) |
| control group | Placebo comparator | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of physical training
Assess the effectiveness of physical training associated with a cognitive training in improving the cognitive functions of patients diagnosed with Mild Cognitive Impairment (MCI). We expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire.
Measured: up to 3 months
Secondary outcomes (1)
Cognitive improvement
Assess the cognitive improvement after three months and after cessation of the intervention.
Assess the impact of the intervention on the cognitive and behavioral, 3 months after cessation of training with maintenance of physical activity by patients.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck LE DUFF, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553929
- Sponsor's protocol ID
- 11-AOI-03
- Acronym
- EPAC-M
- Status last verified
- Aug 2015
- First submitted
- 8 Mar 2012
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Trainig and Cognitive Activity on the MCI Patient
- ClinicalTrials.gov ID
- NCT01553929
- Acronym / sponsor ID
- EPAC-M / 11-AOI-03
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- MCI
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Mar 2012 (estimated)
- 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.
Regular physical activity is now recognized as a key element of good physical and mental health and this all ages.
MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI).
DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group.
In agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. Furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical and cognitive activity group | Experimental | Other: Physical Training and cognitive activity (EPC group) |
| Physical activity group | Active comparator | Other: Physical training (EP group) |
| control group | Placebo comparator | Other: control group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed patient MCI (Mild Cognitive Impairment)
- Elderly from 40 to 75 years old
- MMSE upper to 22
- Affiliated or beneficiary of a national insurance scheme
- Medical capacity to the physical proposed activity (filling of the conditions of the Medical certificate of not contraindication in the sport)
Key exclusion criteria (3 listed)
- The placed persons under guardianship, under protection of justice,
- The private persons of freedom (administrative or judicial)
- Nobody already participating in a clinical trial
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 |
|---|---|---|
| Physical Training and cognitive activity (EPC group)The patients of the EPC group will realize 2 weekly sessions of 20 minutes of pédalage. During the exercise, the patients will realize a series of tests of decision-making and perceptive cognitive capacity. | Other | Physical and cognitive activity group |
| Physical training (EP group)The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage. | Other | Physical activity group |
| control groupno physical training and no cognitive activity | Other | control group |
Primary outcome
effectiveness of physical training
Time frame: up to 3 months
Assess the effectiveness of physical training associated with a cognitive training in improving the cognitive functions of patients diagnosed with Mild Cognitive Impairment (MCI). We expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire.
1 secondary outcome
Cognitive improvement
Time frame: up to 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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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.
Franck LE DUFF, PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Training and cognitive activity (EPC group) and Physical training (EP group) in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Aug 2015. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early. Results are not available in the source record.
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?
effectiveness of physical training (time frame: up to 3 months). 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 14 Aug 2015.