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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03675490
Other study ID # ABLEPILOT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2018
Est. completion date January 2020

Study information

Verified date September 2018
Source McMaster University
Contact Caitlin M McArthur, PhD, MScPT
Phone 905-521-2100
Email mcarthurc@hhsc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date January 2020
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).,

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
McMaster University McMaster Institute for Research on Aging, Physiotherapy Foundation of Canada

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment The number of participants recruited over one year. One year
Primary Retention The number of participants who complete visit 4. Three months
Primary Adherence The number of days per week that participants complete the home exercise program. Three months
Secondary 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 Three months
Secondary Balance Outcome Measure for Elder Rehabilitation (BOOMER) The BOOMER is a measure of static and dynamic balance Three months
Secondary 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 Three months
Secondary 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 Three months
Secondary 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. Three months
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