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

NCT03390478 | Completed DMC

• 1 other identifier: CT_MIND&GAIT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Cognition; Mild Cognitive Impairment

Keywords

Frailty; Aged; Cognitive Stimulation; Technology

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Change from Baseline in the participant's Activities of Daily Living

  Intermediate assessment (week 12)

• Change from Baseline in the participant's Activities of Daily Living

  Post-intervention assessment (week 21)

Study Arms (2)

Control Group

NO INTERVENTION

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

Combined Intervention Group

EXPERIMENTAL

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

Other: Combined Intervention Group

Interventions

Combined Intervention Group 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).

Combined Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Enfermagem de Coimbra: lead
• Instituto Politécnico de Coimbra: collaborator
• Instituto Politécnico de Leiria: collaborator
• Polytechnic University of Santarém: collaborator

Study Sites (1)

Health Sciences Research Unit: Nursing

Coimbra, 3000-232, Portugal

Location

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Related Links

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

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• João Apóstolo, Aggregation

  Nursing School of Coimbra (ESEnfC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization process it will be done in https://www.random.org/ by an independent person.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: João Luís Alves Apóstolo

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 4, 2018
• Study Start: April 23, 2018
• Primary Completion: May 23, 2018
• Study Completion: October 22, 2018
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)