FrailtyMIND&GAITNCT03390478
Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
A study testing Combined Intervention Group in people with Frailty and Cognition, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
Trial summary
A strategy involving 6 partners was planned, targeting the components of education, innovation, and practice-based research with knowledge transfer into clinical practice.The project MIND\&GAIT aims to promote independent living in frail older people through the development of innovative initiatives and systems to… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Cognition, Mild Cognitive Impairment
- What is being tested?
- Combined Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePortugal
- Study dates
- 23 Apr 2018to 22 Oct 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults, age 65 or above;
- Older adults with the ability to consent in an informed manner their participation in the study;
- Older adults with clinical conditions that allow them to participate in the combined intervention;
- Older adults with mild to moderate cognitive frailty criteria as per the 6-CIT scale;
- Older adults with mild to moderate depressive status as per the Geriatric Depression Scale (15 items version).
- Older adults that present mild to moderate risk of fall tracked by Tinetti Index;
- Older adults with physical frailty tracked by the biomechanical gait parameters.
Who cannot join
- Older adults without a stable clinical condition;
- Older adults with a cardiac condition that enables them practice of physical activity;
- Older adults that do not have the desire of participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIND&GAIT - Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
A strategy involving 6 partners was planned, targeting the components of education, innovation, and practice-based research with knowledge transfer into clinical practice.The project MIND\&GAIT aims to promote independent living in frail older people through the development of innovative initiatives and systems to improve cognition and gait ability. A structured and integrated Combined Intervention (CI) will be developed, composed by: cognitive stimulation program, an animal-assisted therapy program, a physical activity program. Moreover, an auto-blocking mechanism for rolling walkers will be developed and implemented in this study. The results of the study and all the material that was used, will be disseminated in a web platform.
Read the detailed description
In this growing context of aging societies, the number of institutionalized older adults tends to increase. Several reasons lead to the institutionalization of older people, including physical and cognitive decline. In Portugal,in the population aged over 60 years, there was approximately 160,287 people with dementia, which corresponds to 5.91% of the people covered by these age groups. Mild cognitive impairment (MCI) is considered as an intermediate state between normal cognitive ageing and mild dementia, particularly in older people. It is increasingly recognized as a major health problem associated with an increased risk for dementia. Cognitive health maintenance is essential for preventing cognitive impairment and delaying the onset of dementia, dependency, and (in)ability to self-care. In older people with cognitive decline, cognitive stimulation can be a promising intervention for reducing depressive symptoms and depressive vulnerability, improving their quality of life. On the other hand, healthy ageing has traditionally focused on disease prevention, but greater efforts are needed to reduce frailty and dependency, and maintain independent physical and cognitive function among older adults. The aging process associated with a sedentary lifestyle can lead to the decline of some physical capacities. Maintaining functional status and reducing age-related morbidity is an important part of active ageing policies; it promotes independent living, improves the quality of life, and reduces health care costs. In this way exercise programs reduce age-related decline in functional capacity and maintain muscle strength and mass among adults aged 65-85 years.
The research team intend to intervene in the promotion of active ageing, including physical exercise and activities that promote the delay and/or maintenance of the cognitive and physical health of frail older people.
In this way, a randomized controlled trial will be conducted by the research team, composed by two arms: experimental group (CI group) and control group. The aim of this study is to assess the impact of the CI program on frail older people. The evaluation of the effectiveness of the Combined Intervention will have the following methodology:
- Sample Test: For sample size calculation it was used the software G*Power 3.1.9.2. Power analysis was based on a type I error of 0.05; power of 0.80; effect size f=0.30; and ANOVA: repeated measures between factors determined a total sample size of 62.Participants with more than 65 or more years will be recruited from two homes for the aged. Participants will be randomly distributed in groups of 8, in the control group and in the experimental group. Participants will be classified as having mild to moderate cognitive decline and risk of fall from mild to moderate. The control group will receive usual care.
-Intervention: The combined intervention will be implemented over 21 weeks, 4 times a week. Cognitive Stimulation Program (CSP) will be applied once a week and Physical Activity Program (PAP) 3 times a week for 30-60 min. Participants using rolling walkers will benefit from the autoblocking kit mechanism for rolling walkers mechanism (ABMRW) during the execution of the PAP.
-Data analysis: Statistical analysis will be performed through repeated meaures and ANOVA. Age, gender, and initial scores of depression and Activities of Daily Living (ADLs) will be introduced as covariates. Intention-to-treat analysis will be done to analyze the data of the people who left the study.
- Conditions
- Frailty, Cognition, Mild Cognitive Impairment
- Being tested
- Combined Intervention Group
- Keywords
- Frailty, Aged, Cognitive Stimulation, Technology
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Intervention GroupOther
Experimental: Combined Intervention Program is composed by a Cognitive Stimulation Program (CSP), a Physical Activity Program (PAP) and Animal Assisted Therapy (AAT). During the PAP participants that use rolling-walkers, will do PAP using the Auto-Blocking kit mechanism for rolling walkers (ABMRW).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The participants that will be assign to the control group will receive institutional usual care. |
| Combined Intervention Group | Experimental | The participants that will be assigned to the experimental group will receive the Combined Intervention Program Receives: Other: Combined Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the participant's Cognition
Outcome measure: "Montreal Cognitive Assessment (MoCA)" - Portuguese version of Freitas, S., Simões, M. R., Santana, I., Martins, C. \& Nasreddine, Z. (2013).
Measured: Intermediate assessment (week 12)
Change from Baseline in the participant's Cognition
Outcome measure: "Montreal Cognitive Assessment (MoCA)" - Portuguese version of Freitas, S., Simões, M. R., Santana, I., Martins, C. \& Nasreddine, Z. (2013).
Measured: Post-intervention assessment (week 21)
Change from Baseline in the participant's Physical Frailty
Outcome measure: "Gait B" with a stopwatch that will be adapted to the specific context. It will also be measure biomechanical parameters of gait using the Novel EMED-X pressure platform. The fall risk it will be measure with "Tinetti Index", original version of Tinetti, Wiliams and Mayewski (1986), translated and adapted to portuguese by Elisa Petiz (2001).
Measured: Intermediate assessment (week 12)
Change from Baseline in the participant's Physical Frailty
Outcome measure: "Gait B" with a stopwatch that will be adapted to the specific context. It will also be measure biomechanical parameters of gait using the Novel EMED-X pressure platform. The fall risk it will be measure with "Tinetti Index", original version of Tinetti, Wiliams and Mayewski (1986), translated and adapted to portuguese by Elisa Petiz (2001).
Measured: Post-intervention assessment (week 21)
Secondary outcomes (2)
Change from Baseline in the participant's Activities of Daily Living
Outcome measure: "Barthel ADL Index - Portuguese version"
Measured: Intermediate assessment (week 12)
Change from Baseline in the participant's Activities of Daily Living
Outcome measure: "Barthel ADL Index - Portuguese version"
Measured: Post-intervention assessment (week 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start23 Apr 2018
- Primary completion23 May 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in two groups, a control group who will receive institutional usual care and an experimental group who will receive the combined intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Coimbra, Instituto Politécnico de Leiria, Polytechnic University of Santarém
- Responsible party
- Principal investigator, Joao Apostolo, Escola Superior de Enfermagem de Coimbra
- Investigators
- João Apóstolo, Aggregation, Principal investigator, Nursing School of Coimbra (ESEnfC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390478
- Sponsor's protocol ID
- CT_MIND&GAIT
- Acronym
- MIND&GAIT
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradley SM, Hernandez CR. Geriatric assistive devices. Am Fam Physician. 2011 Aug 15;84(4):405-11.
PubMed 21842786Peretz C, Korczyn AD, Shatil E, Aharonson V, Birnboim S, Giladi N. Computer-based, personalized cognitive training versus classical computer games: a randomized double-blind prospective trial of cognitive stimulation. Neuroepidemiology. 2011;36(2):91-9. doi: 10.1159/000323950. Epub 2011 Feb 10.
PubMed 21311196Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.
PubMed 3953620Reeves ND, Narici MV, Maganaris CN. Musculoskeletal adaptations to resistance training in old age. Man Ther. 2006 Aug;11(3):192-6. doi: 10.1016/j.math.2006.04.004. Epub 2006 Jun 19.
PubMed 16782393Skelton DA, Beyer N. Exercise and injury prevention in older people. Scand J Med Sci Sports. 2003 Feb;13(1):77-85. doi: 10.1034/j.1600-0838.2003.00300.x.
PubMed 12535321Narici MV, Maganaris CN, Reeves ND, Capodaglio P. Effect of aging on human muscle architecture. J Appl Physiol (1985). 2003 Dec;95(6):2229-34. doi: 10.1152/japplphysiol.00433.2003. Epub 2003 Jul 3.
PubMed 12844499Narici MV, Maffulli N. Sarcopenia: characteristics, mechanisms and functional significance. Br Med Bull. 2010;95:139-59. doi: 10.1093/bmb/ldq008. Epub 2010 Mar 2.
PubMed 20200012Macaluso A, De Vito G. Muscle strength, power and adaptations to resistance training in older people. Eur J Appl Physiol. 2004 Apr;91(4):450-72. doi: 10.1007/s00421-003-0991-3. Epub 2003 Nov 25.
PubMed 14639481Puthoff ML, Nielsen DH. Relationships among impairments in lower-extremity strength and power, functional limitations, and disability in older adults. Phys Ther. 2007 Oct;87(10):1334-47. doi: 10.2522/ptj.20060176. Epub 2007 Aug 7.
PubMed 17684086Skelton DA. Effects of physical activity on postural stability. Age Ageing. 2001 Nov;30 Suppl 4:33-9. doi: 10.1093/ageing/30.suppl_4.33. No abstract available.
PubMed 11769787Paiva, Diana S; Apóstolo, João L. A. 2015. Estudo de adaptação transcultural e validação do Six Item Cognitive Impairment Test . In J. Apóstolo & M. Almeida (Eds). Elderly Health Care Nursing. Monographic Series - Health Sciences Education and Research, 3 - 18. ISBN: 978-989-99426-1-5. Coimbra: Unidade de Investigação em Ciências da Saúde: Enfermagem (UICISA: E) ESEnfC.
Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
PubMed 11380764Carter ND, Kannus P, Khan KM. Exercise in the prevention of falls in older people: a systematic literature review examining the rationale and the evidence. Sports Med. 2001;31(6):427-38. doi: 10.2165/00007256-200131060-00003.
PubMed 11394562Bandeira, M. L., Azevedo, A. B., Gomes, C. S., Tomé, L. P., Mendes, M. F., Baptista, M. I., & Moreira, M. J. (2014). Dinâmicas demográficas e envelhecimento da população portuguesa( 1950-2011): evolução e perspetivas. Lisboa: Francisco Manuel dos Santos.
Santana I, Farinha F, Freitas S, Rodrigues V, Carvalho A. [The Epidemiology of Dementia and Alzheimer Disease in Portugal: Estimations of Prevalence and Treatment-Costs]. Acta Med Port. 2015 Mar-Apr;28(2):182-8. Epub 2015 May 29. Portuguese.
PubMed 26061508
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND&GAIT - Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
- ClinicalTrials.gov ID
- NCT03390478
- Acronym / sponsor ID
- MIND&GAIT / CT_MIND&GAIT
- Conditions
- Frailty, Cognition, Mild Cognitive Impairment
- Keywords
- Frailty, Aged, Cognitive Stimulation, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Coimbra, Instituto Politécnico de Leiria, Polytechnic University of Santarém
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 4 Jan 2018 (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.
A strategy involving 6 partners was planned, targeting the components of education, innovation, and practice-based research with knowledge transfer into clinical practice.The project MIND\&GAIT aims to promote independent living in frail older people through the development of innovative initiatives and systems to improve cognition and gait ability. A structured and integrated Combined Intervention (CI) will be developed, composed by: cognitive stimulation program, an animal-assisted therapy program, a physical activity program. Moreover, an auto-blocking mechanism for rolling walkers will be developed and implemented in this study. The results of the study and all the material that was used, will be disseminated in a web platform.
Detailed description
In this growing context of aging societies, the number of institutionalized older adults tends to increase. Several reasons lead to the institutionalization of older people, including physical and cognitive decline. In Portugal,in the population aged over 60 years, there was approximately 160,287 people with dementia, which corresponds to 5.91% of the people covered by these age groups. Mild cognitive impairment (MCI) is considered as an intermediate state between normal cognitive ageing and mild dementia, particularly in older people. It is increasingly recognized as a major health problem associated with an increased risk for dementia. Cognitive health maintenance is essential for preventing cognitive impairment and delaying the onset of dementia, dependency, and (in)ability to self-care. In older people with cognitive decline, cognitive stimulation can be a promising intervention for reducing depressive symptoms and depressive vulnerability, improving their quality of life. On the other hand, healthy ageing has traditionally focused on disease prevention, but greater efforts are needed to reduce frailty and dependency, and maintain independent physical and cognitive function among older adults. The aging process associated with a sedentary lifestyle can lead to the decline of some physical capacities. Maintaining functional status and reducing age-related morbidity is an important part of active ageing policies; it promotes independent living, improves the quality of life, and reduces health care costs. In this way exercise programs reduce age-related decline in functional capacity and maintain muscle strength and mass among adults aged 65-85 years.
The research team intend to intervene in the promotion of active ageing, including physical exercise and activities that promote the delay and/or maintenance of the cognitive and physical health of frail older people.
In this way, a randomized controlled trial will be conducted by the research team, composed by two arms: experimental group (CI group) and control group. The aim of this study is to assess the impact of the CI program on frail older people. The evaluation of the effectiveness of the Combined Intervention will have the following methodology:
- Sample Test: For sample size calculation it was used the software G*Power 3.1.9.2. Power analysis was based on a type I error of 0.05; power of 0.80; effect size f=0.30; and ANOVA: repeated measures between factors determined a total sample size of 62.Participants with more than 65 or more years will be recruited from two homes for the aged. Participants will be randomly distributed in groups of 8, in the control group and in the experimental group. Participants will be classified as having mild to moderate cognitive decline and risk of fall from mild to moderate. The control group will receive usual care.
-Intervention: The combined intervention will be implemented over 21 weeks, 4 times a week. Cognitive Stimulation Program (CSP) will be applied once a week and Physical Activity Program (PAP) 3 times a week for 30-60 min. Participants using rolling walkers will benefit from the autoblocking kit mechanism for rolling walkers mechanism (ABMRW) during the execution of the PAP.
-Data analysis: Statistical analysis will be performed through repeated meaures and ANOVA. Age, gender, and initial scores of depression and Activities of Daily Living (ADLs) will be introduced as covariates. Intention-to-treat analysis will be done to analyze the data of the people who left the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in two groups, a control group who will receive institutional usual care and an experimental group who will receive the combined intervention.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The participants that will be assign to the control group will receive institutional usual care. |
| Combined Intervention Group | Experimental | Other: Combined Intervention GroupThe participants that will be assigned to the experimental group will receive the Combined Intervention Program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Older adults, age 65 or above;
- Older adults with the ability to consent in an informed manner their participation in the study;
- Older adults with clinical conditions that allow them to participate in the combined intervention;
- Older adults with mild to moderate cognitive frailty criteria as per the 6-CIT scale;
- Older adults with mild to moderate depressive status as per the Geriatric Depression Scale (15 items version).
Key exclusion criteria (3 listed)
- Older adults without a stable clinical condition;
- Older adults with a cardiac condition that enables them practice of physical activity;
- Older adults that do not have the desire of participate in the study.
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 |
|---|---|---|
| Combined Intervention GroupExperimental: Combined Intervention Program is composed by a Cognitive Stimulation Program (CSP), a Physical Activity Program (PAP) and Animal Assisted Therapy (AAT). During the PAP participants that use rolling-walkers, will do PAP using the Auto-Blocking kit mechanism for rolling walkers (ABMRW). | Other | Combined Intervention Group |
Primary outcome
Change from Baseline in the participant's Cognition
Time frame: Intermediate assessment (week 12)
Outcome measure: "Montreal Cognitive Assessment (MoCA)" - Portuguese version of Freitas, S., Simões, M. R., Santana, I., Martins, C. \& Nasreddine, Z. (2013).
Change from Baseline in the participant's Cognition
Time frame: Post-intervention assessment (week 21)
Outcome measure: "Montreal Cognitive Assessment (MoCA)" - Portuguese version of Freitas, S., Simões, M. R., Santana, I., Martins, C. \& Nasreddine, Z. (2013).
Change from Baseline in the participant's Physical Frailty
Time frame: Intermediate assessment (week 12)
Outcome measure: "Gait B" with a stopwatch that will be adapted to the specific context. It will also be measure biomechanical parameters of gait using the Novel EMED-X pressure platform. The fall risk it will be measure with "Tinetti Index", original version of Tinetti, Wiliams and Mayewski (1986), translated and adapted to portuguese by Elisa Petiz (2001).
Change from Baseline in the participant's Physical Frailty
Time frame: Post-intervention assessment (week 21)
Outcome measure: "Gait B" with a stopwatch that will be adapted to the specific context. It will also be measure biomechanical parameters of gait using the Novel EMED-X pressure platform. The fall risk it will be measure with "Tinetti Index", original version of Tinetti, Wiliams and Mayewski (1986), translated and adapted to portuguese by Elisa Petiz (2001).
2 secondary outcomes
Change from Baseline in the participant's Activities of Daily Living
Time frame: Intermediate assessment (week 12)
Change from Baseline in the participant's Activities of Daily Living
Time frame: Post-intervention assessment (week 21)
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 30 Jan 2020.
- Background: PubMed 21842786Bradley SM, Hernandez CR. Geriatric assistive devices. Am Fam Physician. 2011 Aug 15;84(4):405-11.
- Background: PubMed 21311196Peretz C, Korczyn AD, Shatil E, Aharonson V, Birnboim S, Giladi N. Computer-based, personalized cognitive training versus classical computer games: a randomized double-blind prospective trial of cognitive stimulation. Neuroepidemiology. 2011;36(2):91-9. doi: 10.1159/000323950. Epub 2011 Feb 10.
- Background: PubMed 3953620Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.
- Background: PubMed 16782393Reeves ND, Narici MV, Maganaris CN. Musculoskeletal adaptations to resistance training in old age. Man Ther. 2006 Aug;11(3):192-6. doi: 10.1016/j.math.2006.04.004. Epub 2006 Jun 19.
- Background: PubMed 12535321Skelton DA, Beyer N. Exercise and injury prevention in older people. Scand J Med Sci Sports. 2003 Feb;13(1):77-85. doi: 10.1034/j.1600-0838.2003.00300.x.
- Background: PubMed 12844499Narici MV, Maganaris CN, Reeves ND, Capodaglio P. Effect of aging on human muscle architecture. J Appl Physiol (1985). 2003 Dec;95(6):2229-34. doi: 10.1152/japplphysiol.00433.2003. Epub 2003 Jul 3.
- Background: PubMed 20200012Narici MV, Maffulli N. Sarcopenia: characteristics, mechanisms and functional significance. Br Med Bull. 2010;95:139-59. doi: 10.1093/bmb/ldq008. Epub 2010 Mar 2.
- Background: PubMed 14639481Macaluso A, De Vito G. Muscle strength, power and adaptations to resistance training in older people. Eur J Appl Physiol. 2004 Apr;91(4):450-72. doi: 10.1007/s00421-003-0991-3. Epub 2003 Nov 25.
- Background: PubMed 17684086Puthoff ML, Nielsen DH. Relationships among impairments in lower-extremity strength and power, functional limitations, and disability in older adults. Phys Ther. 2007 Oct;87(10):1334-47. doi: 10.2522/ptj.20060176. Epub 2007 Aug 7.
- Background: PubMed 11769787Skelton DA. Effects of physical activity on postural stability. Age Ageing. 2001 Nov;30 Suppl 4:33-9. doi: 10.1093/ageing/30.suppl_4.33. No abstract available.
- BackgroundPaiva, Diana S; Apóstolo, João L. A. 2015. Estudo de adaptação transcultural e validação do Six Item Cognitive Impairment Test . In J. Apóstolo & M. Almeida (Eds). Elderly Health Care Nursing. Monographic Series - Health Sciences Education and Research, 3 - 18. ISBN: 978-989-99426-1-5. Coimbra: Unidade de Investigação em Ciências da Saúde: Enfermagem (UICISA: E) ESEnfC.
- Background: PubMed 11380764Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
- This link is from the official site of COMPETE2020, and it refers to MIND\&GAIT Project.Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
João Apóstolo, Aggregation principal investigator
Nursing School of Coimbra (ESEnfC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Intervention Group in people with Frailty and Cognition, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
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 7 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: finished, as of the sponsor's last update on 30 Jan 2020. 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 Portugal. 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?
Change from Baseline in the participant's Cognition (time frame: Intermediate assessment (week 12)). The study lists 4 primary outcomes in all. 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 NCT03390478, which also lists 48 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 30 Jan 2020.