ABLE (Arts-Based Exercise Enhancing LongEvity)

Sponsor
McMaster University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03675490
Collaborator
McMaster Institute for Research on Aging (Other), Physiotherapy Foundation of Canada (Other)
25
1
15

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ABLE - exercise with interactive technology
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pre-post pilot feasibilitypre-post pilot feasibility
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

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.

Behavioral: ABLE - exercise with interactive technology
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).,

Outcome Measures

Primary Outcome Measures

  1. Recruitment [One year]

    The number of participants recruited over one year.

  2. Retention [Three months]

    The number of participants who complete visit 4.

  3. Adherence [Three months]

    The number of days per week that participants complete the home exercise program.

Secondary Outcome Measures

  1. Short Physical Performance Battery (SPPB) [Three months]

    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

  2. Balance Outcome Measure for Elder Rehabilitation (BOOMER) [Three months]

    The BOOMER is a measure of static and dynamic balance

  3. International Physical Activity Questionnaire (IPAQ) [Three months]

    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

  4. Self-reported falls as reported in daily diary [Three months]

    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

  5. Participant feedback [Three months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • McMaster University
  • McMaster Institute for Research on Aging
  • Physiotherapy Foundation of Canada

Investigators

  • Principal Investigator: Alexandra Papaioannou, MD, MSc, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT03675490
Other Study ID Numbers:
  • ABLEPILOT
First Posted:
Sep 18, 2018
Last Update Posted:
Sep 18, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2018