Impaired CognitionAFISDEMyFNCT02044887
Physical Activity to Patients With Dementia and Their Caregivers.
A study testing physical activity in people with Impaired Cognition, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
Objective: To assess the effectiveness of an intervention in Primary Health Care to increase the physical activity (PA) and improve cognitive state and cardiovascular risk in patients with dementia and their relative caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Cognition
- What is being tested?
- physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2014to 1 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with dementia residing in a home in the area of the health center.
- identification of family members, or friends (not professional caregiver), who provide most of the care to the PCD.
- completion of informed consent on the part of the caregiver (and PCD) where appropriate.
- the PCD does not take drugs that may negatively affect cognitive function during the period of intervention.
Who cannot join
- mental disorders due to diseases, medical or related substances (DSM-IV-TR).
- stages of dementia (6 or 7 GDS),
- Delirum.
- comorbidity that prevents performing the exercise program intervention: unstable heart disease, bedridden, need walkers or wheelchair, diseases significant stroke, bone and muscle disorders, major psychiatric, neurological or metabolic alterations.
- severe clinical events within the 6 months prior.
- on waiting list of surgical interventions or treatments that require a hospital stay, or forecast stays out of the capital more than 4 weeks during the intervention.
Show all 9Show fewer
- the caregiver dissent to participate in the trial.
- participants who submit any psychological or general medical condition which in the opinion of the investigator may impede the fulfilment of the questionnaires in the Protocol
- participants who are participating at the time of the start of the study in a clinical trial or study with medications.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investigación, Centro de Salud La Alamedilla.
Salamanca, 37003
About this study
Official title: Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF
Objective: To assess the effectiveness of an intervention in Primary Health Care to increase the physical activity (PA) and improve cognitive state and cardiovascular risk in patients with dementia and their relative caregivers.
The results can be used to improve the technical characteristics of the devices that record the physical activity of patients with dementia make marketing easier
Read the detailed description
Methodology: Design: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be assigned to control or intervention group (1:1). Variables: The main measure will be the assessment of PA (pedometer and 7-Day PAR) in patients and caregivers. In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life.
INTERVENTION: For 3 months, participants will receive instructions to do PA with an adapted PA program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and caregivers. The control group will receive regular care.
ANALYSIS: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the pedometer and 7-day PAR will If the main hypothesis is confirmed , it could be useful to improve the cardiovascular risk of all of them , as well as the cognitive state of patients with dementia..
- Conditions
- Impaired Cognition
- Being tested
- physical activity
- Keywords
- Physical activity, dementia, relative caregivers, podometer, cardiovascular risk
- Medical subject headings
- Cognition Disorders, Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
Also called physical activity with an adapted physical activity program, PEPAF
The characteristics of the PCD and CF and motivation will be evaluated to increase the AF through the (Test Prochaska-Diclemente). For 3 months will receive instructions to perform AF autonomously (walking, preferably in the vicinity of the place of residence). The intervention will be conducted by a professional of the health center so only couples of the intervention group will have knowledge of the specific recommendations of the AFISDEMYF. It is an intervention that has demonstrated its effectiveness in the PEPAF study (large, Sanchez et al. 2009) adapted, designed and implemented by primary care professionals for patients with dementia and for family members who care for them.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | Participants will receive instructions to do physical activity with an adapted physical activity program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and caregivers. Receives: Other: physical activity |
| Control | No intervention | The control group will receive regular care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (podometer and 7-Day PAR) in patients and caregivers
The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers.
Measured: 12 months
Secondary outcomes (1)
ADAS-cog, functional degree and cardiovascular risk
In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers:
cardiovascular risk, general health and quality of lif
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impaired CognitionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emiliano Rodriguez, MD, Principal investigator, Fundacion Infosalud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044887
- Sponsor's protocol ID
- GRS772/B/13
- Acronym
- AFISDEMyF
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2014
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez-Sanchez E, Patino-Alonso MC, Mora-Simon S, Gomez-Marcos MA, Perez-Penaranda A, Losada-Baltar A, Garcia-Ortiz L. Effects of a psychological intervention in a primary health care center for caregivers of dependent relatives: a randomized trial. Gerontologist. 2013 Jun;53(3):397-406. doi: 10.1093/geront/gns086. Epub 2012 Aug 16.
PubMed 22899425Garcia-Garcia A, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Rodriguez-Sanchez E, Agudo-Conde C, Garcia-Ortiz L; Vaso-risk group. Office and 24-hour heart rate and target organ damage in hypertensive patients. BMC Cardiovasc Disord. 2012 Mar 22;12:19. doi: 10.1186/1471-2261-12-19.
PubMed 22439900Rodriguez-Sanchez E, Mora-Simon S, Patino-Alonso MC, Garcia-Garcia R, Escribano-Hernandez A, Garcia-Ortiz L, Perea-Bartolome MV, Gomez-Marcos MA. Prevalence of cognitive impairment in individuals aged over 65 in an urban area: DERIVA study. BMC Neurol. 2011 Nov 17;11:147. doi: 10.1186/1471-2377-11-147.
PubMed 22093337Rodriguez-Sanchez E, Criado-Gutierrez JM, Mora-Simon S, Muriel-Diaz MP, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Valero-Juan LF, Maderuelo-Fernandez JA, Garcia-Ortiz L; DERIVA Group. Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study). BMC Neurol. 2014 Apr 1;14:63. doi: 10.1186/1471-2377-14-63.
PubMed 24684948
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF
- ClinicalTrials.gov ID
- NCT02044887
- Acronym / sponsor ID
- AFISDEMyF / GRS772/B/13
- Conditions
- Impaired Cognition
- Keywords
- Physical activity, dementia, relative caregivers, podometer, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 24 Jan 2014 (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.
Objective: To assess the effectiveness of an intervention in Primary Health Care to increase the physical activity (PA) and improve cognitive state and cardiovascular risk in patients with dementia and their relative caregivers.
The results can be used to improve the technical characteristics of the devices that record the physical activity of patients with dementia make marketing easier
Detailed description
Methodology: Design: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be assigned to control or intervention group (1:1). Variables: The main measure will be the assessment of PA (pedometer and 7-Day PAR) in patients and caregivers. In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life.
INTERVENTION: For 3 months, participants will receive instructions to do PA with an adapted PA program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and caregivers. The control group will receive regular care.
ANALYSIS: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the pedometer and 7-day PAR will If the main hypothesis is confirmed , it could be useful to improve the cardiovascular risk of all of them , as well as the cognitive state of patients with dementia..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Other: physical activityParticipants will receive instructions to do physical activity with an adapted physical activity program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and caregivers. |
| Control | No intervention | –The control group will receive regular care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with dementia residing in a home in the area of the health center.
- identification of family members, or friends (not professional caregiver), who provide most of the care to the PCD.
- completion of informed consent on the part of the caregiver (and PCD) where appropriate.
- the PCD does not take drugs that may negatively affect cognitive function during the period of intervention.
Key exclusion criteria (9 listed)
- mental disorders due to diseases, medical or related substances (DSM-IV-TR).
- stages of dementia (6 or 7 GDS),
- Delirum.
- comorbidity that prevents performing the exercise program intervention: unstable heart disease, bedridden, need walkers or wheelchair, diseases significant stroke, bone and muscle disorders, major psychiatric, neurological or metabolic alterations.
- severe clinical events within the 6 months prior.
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 activityAlso: physical activity with an adapted physical activity program, PEPAFThe characteristics of the PCD and CF and motivation will be evaluated to increase the AF through the (Test Prochaska-Diclemente). For 3 months will receive instructions to perform AF autonomously (walking, preferably in the vicinity of the place of residence). The intervention will be conducted by a professional of the health center so only couples of the intervention group will have knowledge of the specific recommendations of the AFISDEMYF. It is an intervention that has demonstrated its effectiveness in the PEPAF study (large, Sanchez et al. 2009) adapted, designed and implemented by primary care professionals for patients with dementia and for family members who care for them. | Other | INTERVENTION |
Primary outcome
Physical activity (podometer and 7-Day PAR) in patients and caregivers
Time frame: 12 months
The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers.
1 secondary outcome
ADAS-cog, functional degree and cardiovascular risk
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Background: PubMed 22899425Rodriguez-Sanchez E, Patino-Alonso MC, Mora-Simon S, Gomez-Marcos MA, Perez-Penaranda A, Losada-Baltar A, Garcia-Ortiz L. Effects of a psychological intervention in a primary health care center for caregivers of dependent relatives: a randomized trial. Gerontologist. 2013 Jun;53(3):397-406. doi: 10.1093/geront/gns086. Epub 2012 Aug 16.
- Background: PubMed 22439900Garcia-Garcia A, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Rodriguez-Sanchez E, Agudo-Conde C, Garcia-Ortiz L; Vaso-risk group. Office and 24-hour heart rate and target organ damage in hypertensive patients. BMC Cardiovasc Disord. 2012 Mar 22;12:19. doi: 10.1186/1471-2261-12-19.
- Background: PubMed 22093337Rodriguez-Sanchez E, Mora-Simon S, Patino-Alonso MC, Garcia-Garcia R, Escribano-Hernandez A, Garcia-Ortiz L, Perea-Bartolome MV, Gomez-Marcos MA. Prevalence of cognitive impairment in individuals aged over 65 in an urban area: DERIVA study. BMC Neurol. 2011 Nov 17;11:147. doi: 10.1186/1471-2377-11-147.
- Derived from this study: PubMed 24684948Rodriguez-Sanchez E, Criado-Gutierrez JM, Mora-Simon S, Muriel-Diaz MP, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Valero-Juan LF, Maderuelo-Fernandez JA, Garcia-Ortiz L; DERIVA Group. Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study). BMC Neurol. 2014 Apr 1;14:63. doi: 10.1186/1471-2377-14-63.
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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.
Emiliano Rodriguez, MD principal investigator
Fundacion Infosalud
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 activity in people with Impaired Cognition, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 23 Nov 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity (podometer and 7-Day PAR) in patients and caregivers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044887, which also lists 4 linked publications.
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 23 Nov 2022.