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ABLE (Arts-Based Exercise Enhancing LongEvity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675490
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
McMaster Institute for Research on Aging
Physiotherapy Foundation of Canada
Information provided by (Responsible Party):
McMaster University

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
Aging Fall Muscle Weakness Mobility Limitation Behavioral: ABLE - exercise with interactive technology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: pre-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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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).,




Primary Outcome Measures :
  1. Recruitment [ Time Frame: One year ]
    The number of participants recruited over one year.

  2. Retention [ Time Frame: Three months ]
    The number of participants who complete visit 4.

  3. Adherence [ Time Frame: Three months ]
    The number of days per week that participants complete the home exercise program.


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: 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) [ Time Frame: Three months ]
    The BOOMER is a measure of static and dynamic balance

  3. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675490


Contacts
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Contact: Caitlin M McArthur, PhD, MScPT 905-521-2100 ext 77716 mcarthurc@hhsc.ca
Contact: Jessica Belgrave Sookhoo, BSc 905-521-2100 ext 12232 belgravej@hhsc.ca

Sponsors and Collaborators
McMaster University
McMaster Institute for Research on Aging
Physiotherapy Foundation of Canada
Investigators
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Principal Investigator: Alexandra Papaioannou, MD, MSc McMaster University
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03675490    
Other Study ID Numbers: ABLEPILOT
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Mobility Limitation
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms