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ABLE (Arts-Based Exercise Enhancing LongEvity)

Primary Purpose

Aging, Fall, Muscle Weakness

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABLE - exercise with interactive technology
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • able to stand and walk independently with or without an assistive aid (e.g., walker, cane)
  • may have a diagnosis of dementia or cognitive impairment (MoCA < 25, MMSE <24, Mini-Cog <3) if they have caregiver willing to assist with exercises and consent

Exclusion Criteria:

  • have a diagnosis of dementia or cognitive impairment (MoCA < 25, MMSE <24, Mini-Cog <3) and have no family member to assist with exercises and consent
  • documented absolute contraindications to exercise

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Exercise

    Arm Description

    Participants will engage in a physiotherapist-prescribed home exercise program with ABLE, the interactive technology. The exercises that will be prescribed are designed to improve functional mobility via challenging lower extremity strength and balance in a multicomponent exercise program. The difficulty of each exercise will be chosen at the discretion of the physiotherapist based on the participants' performance on the baseline assessments. The exercises will be prescribed at a moderate intensity (moderate balance challenge, 8-12 repetitions for strength exercises with the last few repetitions being challenging) and will be progressed over the study duration to ensure they remain a moderate challenge.

    Outcomes

    Primary Outcome Measures

    Recruitment
    The number of participants recruited over one year.
    Retention
    The number of participants who complete visit 4.
    Adherence
    The number of days per week that participants complete the home exercise program.

    Secondary Outcome Measures

    Short Physical Performance Battery (SPPB)
    The SPPB is a measure of lower extremity function through measures of balance (timed static stance in feet together, semi-tandem and tandem with eyes open), gait speed, and the time to rise from a chair
    Balance Outcome Measure for Elder Rehabilitation (BOOMER)
    The BOOMER is a measure of static and dynamic balance
    International Physical Activity Questionnaire (IPAQ)
    The IPAQ is a self-report measure of time spent (e.g., duration per session, and number of session in the past 7 days) in strength training, yoga/Tai Chi/other balance activities, vigorous physical activity, moderate physical activity, walking, and sitting/lying down while awake
    Self-reported falls as reported in daily diary
    A slip or a trip where the person loses their balance and part or all of their body lands on the ground, floor, or lower level
    Participant feedback
    Participants and their caregivers (if they assisted with the intervention) will provide their feedback on the technology and participation in the pilot study via one-on-one qualitative interviews completed during the last study visit.

    Full Information

    First Posted
    September 13, 2018
    Last Updated
    September 14, 2018
    Sponsor
    McMaster University
    Collaborators
    McMaster Institute for Research on Aging, Physiotherapy Foundation of Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03675490
    Brief Title
    ABLE (Arts-Based Exercise Enhancing LongEvity)
    Official Title
    ABLE (Arts-Based Exercise Enhancing LongEvity): Interactive, Arts-based Technology to Support Sustainable Exercise Participation in the Homes of Older Adults: Protocol for a Pre-post Pilot Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    McMaster Institute for Research on Aging, Physiotherapy Foundation of Canada

    4. Oversight

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

    5. Study Description

    Brief Summary
    Older adults who are referred to home care physiotherapy often only get to see the physiotherapist three to five times and are expected to continue exercising on their own. We have developed an interactive technology called ABLE that helps older adults do exercise in their homes by making it fun and interactive. We want to see if we can help 25 older adults to exercise with ABLE for three months and if exercising with ABLE for three months changes older adults' strength and balance. A physiotherapist will visit the older adults three times in their homes and show them how to use ABLE and which exercises to do. We will measure older adults' strength and balance before and after using the program and ask them and their family members for feedback about using ABLE. The results of our study will help us decide if we can do a bigger study to test the effect of using ABLE in a larger group of older adults, and to see what effect ABLE might have on strength and balance. The study will also help us incorporate feedback from the older adults and their families to improve ABLE for the next study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging, Fall, Muscle Weakness, Mobility Limitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    pre-post pilot feasibility
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    Participants will engage in a physiotherapist-prescribed home exercise program with ABLE, the interactive technology. The exercises that will be prescribed are designed to improve functional mobility via challenging lower extremity strength and balance in a multicomponent exercise program. The difficulty of each exercise will be chosen at the discretion of the physiotherapist based on the participants' performance on the baseline assessments. The exercises will be prescribed at a moderate intensity (moderate balance challenge, 8-12 repetitions for strength exercises with the last few repetitions being challenging) and will be progressed over the study duration to ensure they remain a moderate challenge.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ABLE - exercise with interactive technology
    Intervention Description
    Multicomponent exercise with interactive technology - consists of wearable sensors and a screen displaying interaction. When the person does the exercises it produces an arts-based response on the screen (e.g., digital painting).,
    Primary Outcome Measure Information:
    Title
    Recruitment
    Description
    The number of participants recruited over one year.
    Time Frame
    One year
    Title
    Retention
    Description
    The number of participants who complete visit 4.
    Time Frame
    Three months
    Title
    Adherence
    Description
    The number of days per week that participants complete the home exercise program.
    Time Frame
    Three months
    Secondary Outcome Measure Information:
    Title
    Short Physical Performance Battery (SPPB)
    Description
    The SPPB is a measure of lower extremity function through measures of balance (timed static stance in feet together, semi-tandem and tandem with eyes open), gait speed, and the time to rise from a chair
    Time Frame
    Three months
    Title
    Balance Outcome Measure for Elder Rehabilitation (BOOMER)
    Description
    The BOOMER is a measure of static and dynamic balance
    Time Frame
    Three months
    Title
    International Physical Activity Questionnaire (IPAQ)
    Description
    The IPAQ is a self-report measure of time spent (e.g., duration per session, and number of session in the past 7 days) in strength training, yoga/Tai Chi/other balance activities, vigorous physical activity, moderate physical activity, walking, and sitting/lying down while awake
    Time Frame
    Three months
    Title
    Self-reported falls as reported in daily diary
    Description
    A slip or a trip where the person loses their balance and part or all of their body lands on the ground, floor, or lower level
    Time Frame
    Three months
    Title
    Participant feedback
    Description
    Participants and their caregivers (if they assisted with the intervention) will provide their feedback on the technology and participation in the pilot study via one-on-one qualitative interviews completed during the last study visit.
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: able to stand and walk independently with or without an assistive aid (e.g., walker, cane) may have a diagnosis of dementia or cognitive impairment (MoCA < 25, MMSE <24, Mini-Cog <3) if they have caregiver willing to assist with exercises and consent Exclusion Criteria: have a diagnosis of dementia or cognitive impairment (MoCA < 25, MMSE <24, Mini-Cog <3) and have no family member to assist with exercises and consent documented absolute contraindications to exercise
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caitlin M McArthur, PhD, MScPT
    Phone
    905-521-2100
    Ext
    77716
    Email
    mcarthurc@hhsc.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica Belgrave Sookhoo, BSc
    Phone
    905-521-2100
    Ext
    12232
    Email
    belgravej@hhsc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandra Papaioannou, MD, MSc
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data available upon request.

    Learn more about this trial

    ABLE (Arts-Based Exercise Enhancing LongEvity)

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