An interventional study of Combined Intervention Group in Frailty, Cognition and Mild Cognitive Impairment, sponsored by Escola Superior de Enfermagem de Coimbra. Completed at 1 site in Portugal. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Escola Superior de Enfermagem de Coimbra · Not applicable, Interventional, and Prevention
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.
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:
-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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's enrollment of 62 is below the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Escola Superior de Enfermagem de Coimbra is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The participants that will be assign to the control group will receive institutional usual care.
The participants that will be assigned to the experimental group will receive the Combined Intervention Program
Other: Combined Intervention Group
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).
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Post-intervention assessment (week 21)
Change from Baseline in the participant's Activities of Daily Living
Outcome measure: "Barthel ADL Index - Portuguese version"
Time frame: Intermediate assessment (week 12)
Change from Baseline in the participant's Activities of Daily Living
Outcome measure: "Barthel ADL Index - Portuguese version"
Time frame: Post-intervention assessment (week 21)
Plan to share: No
Ran from Apr 2018 to primary completion in May 2018, 1 month.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 1 month is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Escola Superior de Enfermagem de Coimbra