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

January 29, 2020 updated by: Joao Apostolo, Escola Superior de Enfermagem de Coimbra

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-232
        • Health Sciences Research Unit: Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Intermediate assessment (week 12)
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).
Post-intervention assessment (week 21)
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).
Intermediate assessment (week 12)
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).
Post-intervention assessment (week 21)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Enfermagem de Coimbra

Collaborators

Instituto Politécnico de Leiria
Instituto Politécnico de Santarém
Instituto Politécnico de Coimbra

Investigators

  • Principal Investigator: João Apóstolo, Aggregation, Nursing School of Coimbra (ESEnfC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Actual)

May 23, 2018

Study Completion (Actual)

October 22, 2018

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

December 29, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT_MIND&GAIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty

Clinical Trials on Combined Intervention Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe