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

NCT ID: NCT03390478

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2018-10-22

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control Group

The participants that will be assign to the control group will receive institutional usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Combined Intervention Group

The participants that will be assigned to the experimental group will receive the Combined Intervention Program

Group Type: EXPERIMENTAL

Combined Intervention Group

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Politécnico de Coimbra

UNKNOWN

Sponsor Role: collaborator

Instituto Politécnico de Leiria

OTHER

Sponsor Role: collaborator

Polytechnic University of Santarém

OTHER

Sponsor Role: collaborator

Escola Superior de Enfermagem de Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Joao Apostolo

João Luís Alves Apóstolo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João Apóstolo, Aggregation

Role: PRINCIPAL_INVESTIGATOR

Nursing School of Coimbra (ESEnfC)

Locations

Health Sciences Research Unit: Nursing

Coimbra, , Portugal

Countries

Portugal

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Related Links

https://www.esenfc.pt/pt/page/100004128?idMenu=401

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

http://www.poci-compete2020.pt/newsletter/detalhe/Proj23822_MInd&Gait

This link is from the official site of COMPETE2020, and it refers to MIND\&GAIT Project.

Other Identifiers

CT_MIND&GAIT

Identifier Type: -

Identifier Source: org_study_id