AgingNCT03675490
ABLE (Arts-Based Exercise Enhancing LongEvity)
A study testing ABLE - exercise with interactive technology in people with Aging and Fall, run by McMaster University.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Fall, Muscle Weakness
- What is being tested?
- ABLE - exercise with interactive technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Aging, Fall, Muscle Weakness, Mobility Limitation
- Being tested
- ABLE - exercise with interactive technology
- Medical subject headings
- Muscle Weakness, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLE - exercise with interactive technologyBehavioural
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).,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ABLE - exercise with interactive technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The number of participants recruited over one year.
Measured: One year
Retention
The number of participants who complete visit 4.
Measured: Three months
Adherence
The number of days per week that participants complete the home exercise program.
Measured: Three months
Secondary outcomes (5)
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
Measured: Three months
Balance Outcome Measure for Elder Rehabilitation (BOOMER)
The BOOMER is a measure of static and dynamic balance
Measured: Three months
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
Measured: Three months
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
Measured: Three months
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post pilot feasibility
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Institute for Research on Aging, Physiotherapy Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Alexandra Papaioannou, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675490
- Sponsor's protocol ID
- ABLEPILOT
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03675490
- Acronym / sponsor ID
- ABLEPILOT
- Conditions
- Aging, Fall, Muscle Weakness, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Institute for Research on Aging, Physiotherapy Foundation of Canada
- Study start
- Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post pilot feasibility
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ABLE - exercise with interactive technologyParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABLE - exercise with interactive technologyMulticomponent 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)., | Behavioural | Exercise |
Primary outcome
Recruitment
Time frame: One year
The number of participants recruited over one year.
Retention
Time frame: Three months
The number of participants who complete visit 4.
Adherence
Time frame: Three months
The number of days per week that participants complete the home exercise program.
5 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Three months
Balance Outcome Measure for Elder Rehabilitation (BOOMER)
Time frame: Three months
International Physical Activity Questionnaire (IPAQ)
Time frame: Three months
Self-reported falls as reported in daily diary
Time frame: Three months
Participant feedback
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: Undecided. Data available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Papaioannou, MD, MSc principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing ABLE - exercise with interactive technology in people with Aging and Fall, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caitlin M McArthur, PhD, MScPT (905-521-2100 ext. 77716, mcarthurc@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.