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

Primary Purpose

Frailty, Cognition, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Combined Intervention Group
Sponsored by
Escola Superior de Enfermagem de Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring Frailty, Aged, Cognitive Stimulation, Technology

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Health Sciences Research Unit: Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Combined Intervention Group

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Change from Baseline in the participant's Activities of Daily Living
Outcome measure: "Barthel ADL Index - Portuguese version"
Change from Baseline in the participant's Activities of Daily Living
Outcome measure: "Barthel ADL Index - Portuguese version"

Full Information

First Posted
December 29, 2017
Last Updated
January 29, 2020
Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
Instituto Politécnico de Coimbra, Instituto Politécnico de Leiria, Instituto Politécnico de Santarém
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1. Study Identification

Unique Protocol Identification Number
NCT03390478
Brief Title
Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
Acronym
MIND&GAIT
Official Title
MIND&GAIT - Promoting Independent Living in Frail Older Adults by Improving Cognition and Gait Ability and Using Assistive Products
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
Instituto Politécnico de Coimbra, Instituto Politécnico de Leiria, Instituto Politécnico de Santarém

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Cognition, Mild Cognitive Impairment
Keywords
Frailty, Aged, Cognitive Stimulation, Technology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The randomization process it will be done in https://www.random.org/ by an independent person.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The participants that will be assign to the control group will receive institutional usual care.
Arm Title
Combined Intervention Group
Arm Type
Experimental
Arm Description
The participants that will be assigned to the experimental group will receive the Combined Intervention Program
Intervention Type
Other
Intervention Name(s)
Combined Intervention Group
Intervention Description
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 Measure Information:
Title
Change from Baseline in the participant's Cognition
Description
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)
Title
Change from Baseline in the participant's Cognition
Description
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)
Title
Change from Baseline in the participant's Physical Frailty
Description
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)
Title
Change from Baseline in the participant's Physical Frailty
Description
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)
Secondary Outcome Measure Information:
Title
Change from Baseline in the participant's Activities of Daily Living
Description
Outcome measure: "Barthel ADL Index - Portuguese version"
Time Frame
Intermediate assessment (week 12)
Title
Change from Baseline in the participant's Activities of Daily Living
Description
Outcome measure: "Barthel ADL Index - Portuguese version"
Time Frame
Post-intervention assessment (week 21)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Apóstolo, Aggregation
Organizational Affiliation
Nursing School of Coimbra (ESEnfC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Research Unit: Nursing
City
Coimbra
ZIP/Postal Code
3000-232
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.esenfc.pt/pt/page/100004128?idMenu=401
Description
This link is from the official site of Nursing School of Coimbra, and it refers to MIND&GAIT Project.
URL
http://www.poci-compete2020.pt/newsletter/detalhe/Proj23822_MInd&Gait
Description
This link is from the official site of COMPETE2020, and it refers to MIND&GAIT Project.

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

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