Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products

Mild Cognitive Impairment Clinical Trial

— MIND&GAIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390478
• Other study ID #: CT_MIND&GAIT
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: October 22, 2018

Study information

• Verified date: January 2020
• Source: Escola Superior de Enfermagem de Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 22, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Cognitive Dysfunction
• Frailty
• Mild Cognitive Impairment

Intervention

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).

Locations

Country	Name	City	State
Portugal	Health Sciences Research Unit: Nursing	Coimbra

Sponsors (4)

Lead Sponsor	Collaborator
Escola Superior de Enfermagem de Coimbra	Instituto Politécnico de Coimbra, Instituto Politécnico de Leiria, Instituto Politécnico de Santarém

Country where clinical trial is conducted

Portugal, 

References & Publications (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Intermediate assessment (week 12)
Primary	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).	Post-intervention assessment (week 21)
Primary	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).	Intermediate assessment (week 12)
Primary	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).	Post-intervention assessment (week 21)
Secondary	Change from Baseline in the participant's Activities of Daily Living	Outcome measure: "Barthel ADL Index - Portuguese version"	Intermediate assessment (week 12)
Secondary	Change from Baseline in the participant's Activities of Daily Living	Outcome measure: "Barthel ADL Index - Portuguese version"	Post-intervention assessment (week 21)

External Links

•   This link is from the official site of COMPETE2020, and it refers to MIND&GAIT Project.
•   This link is from the official site of Nursing School of Coimbra, and it refers to MIND&GAIT Project.