NCT03675490

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 13, 2018

Last Update Submit

September 14, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recruitment

    The number of participants recruited over one year.

    One year

  • Retention

    The number of participants who complete visit 4.

    Three months

  • Adherence

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

    Three months

Secondary Outcomes (5)

  • Short Physical Performance Battery (SPPB)

    Three months

  • Balance Outcome Measure for Elder Rehabilitation (BOOMER)

    Three months

  • International Physical Activity Questionnaire (IPAQ)

    Three months

  • Self-reported falls as reported in daily diary

    Three months

  • Participant feedback

    Three months

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

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).,

Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscle WeaknessMobility Limitation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Alexandra Papaioannou, MD, MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin M McArthur, PhD, MScPT

CONTACT

Jessica Belgrave Sookhoo, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: pre-post pilot feasibility
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 18, 2018

Study Start

October 1, 2018

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

September 18, 2018

Record last verified: 2018-09