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Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products (MIND&GAIT)

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ClinicalTrials.gov Identifier: NCT03390478
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
Instituto Politécnico de Coimbra
Instituto Politécnico de Leiria
Instituto Politécnico de Santarém
Information provided by (Responsible Party):
Joao Apostolo, Escola Superior de Enfermagem de Coimbra

Brief 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 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.

Condition or disease Intervention/treatment Phase
Frailty Cognition Mild Cognitive Impairment Other: Combined Intervention Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: The randomization process it will be done in https://www.random.org/ by an independent person.
Primary Purpose: Prevention
Official Title: MIND&GAIT - Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : October 22, 2018

Arm Intervention/treatment
No Intervention: Control Group
The participants that will be assign to the control group will receive institutional usual care.
Experimental: Combined Intervention Group
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).




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).


Secondary Outcome Measures :
  1. Change from Baseline in the participant's Activities of Daily Living [ Time Frame: Intermediate assessment (week 12) ]
    Outcome measure: "Barthel ADL Index - Portuguese version"

  2. Change from Baseline in the participant's Activities of Daily Living [ Time Frame: Post-intervention assessment (week 21) ]
    Outcome measure: "Barthel ADL Index - Portuguese version"



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390478


Locations
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Portugal
Health Sciences Research Unit: Nursing
Coimbra, Portugal, 3000-232
Sponsors and Collaborators
Escola Superior de Enfermagem de Coimbra
Instituto Politécnico de Coimbra
Instituto Politécnico de Leiria
Instituto Politécnico de Santarém
Investigators
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Principal Investigator: João Apóstolo, Aggregation Nursing School of Coimbra (ESEnfC)

Additional Information:
Publications:
Paiva, 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.
Bandeira, 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.
Sousa, R. (2015). Prevenção de quedas na população geriátrica artigo de revisão. Coimbra, Portugal: Faculdade de Medicina da Universidade de Coimbra.
European Union. (2013). Action Group A3 on Prevention and early diagnosis of frailty and functional decline, both physically and cognitive, in older people: A compilation of good practices. The European Innovation Partnership on Active and Healthy Ageing.
Elliott, S. M. (2015). The Psychological Benefits of Animal Assisted Therapy on Elderly Nursing Home Patients. University of Akron: Ohio?s Polytechnic University.
Bono, A. V., BenVenuti, C., Buzzi, M., CiAtti, R., ChiARelli, V., ChiAMBRetto, P., ... & PinCiRoli, M. (2015). Effects of animal assisted therapy (AAT) carried out with dogs on the evolution of mild cognitive impairment. G Gerontol, 63, 32-36.
Apóstolo, J., & Cardoso, D. (2014a). Estimulação Cognitiva em Idosos - Síntese da Evidência e Intervenção. In L. coord. Loureiro (Ed.), Literacia em Saúde Mental - Capacitar as pessoas e as Comunidades para Agir (pp. 157?183). Coimbra: Unidade de Investigação em Ciências da Saúde: Enfermagem e Escola Superior de Enfermagem de Coimbra.
Apóstolo, J., & Cardoso, D. (2014b). Estimulação Cognitiva em Idosos - Síntese da Evidência e Intervenção: Programa de Manutenção. In M. Apóstolo, J.; Almeida (Ed.), Envelhecimento, Saúde e Cidadania 2: Monographic Series Health Sciences Education and Research (pp. 37?66). Coimbra.
Cognitive stimulation and brain fitness. In Action Group A3 on Prevention and early diagnosis of frailty and functional decline, both physically and cognitive, in older people: A compilation of good practices. The European Innovation Partnership on Active and Healthy Ageing.
Apóstolo, J., Loureiro, L., Reis, I., Silva, I., Cardoso, D., & Sfectcu, R. (2014). Contribuição para a adaptação da Geriatric Depression Scale -15 para a língua portuguesa. Revista de Enfermagem Referência, Série 3 (3), 65?73.
American College of Sports Medicine. (2013). ACSM's guidelines for exercise testing and prescription. Lippincott Williams & Wilkins. ISBN-13: 978-1609136055.
Madeira, J., Silva, C., Marcelino, L., & Ferreira, P. (2015). Assistive Mobile Applications for Dyslexia. Procedia Computer Science, 64, 417-424.

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Responsible Party: Joao Apostolo, João Luís Alves Apóstolo, Escola Superior de Enfermagem de Coimbra
ClinicalTrials.gov Identifier: NCT03390478    
Other Study ID Numbers: CT_MIND&GAIT
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joao Apostolo, Escola Superior de Enfermagem de Coimbra:
Frailty
Aged
Cognitive Stimulation
Technology
Additional relevant MeSH terms:
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Frailty
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pathologic Processes