- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06823882
Practicing Getting Up from the Floor to Reduce Fear of Falling and Improve Floor-Rise Ability in Community-Dwelling Older Adults: a Pilot Study
The Impact of Floor-rise Training on Fear of Falling and Independent Floor-rise Ability in Older Adults Living in the Community: a Pilot Cluster Randomised Controlled Trial with Multiple Methods.
Goal:
This pilot study aims to determine whether practicing getting down to and standing up from the floor reduces fear of falling (FoF) and improves older adults' ability to complete this task. The study compares this to a control group that watches educational videos on the same topic. This practice is referred to as Floor-Rise Training (FRT).
Main Questions:
- Can a short FRT intervention reduce fear of falling?
- Can a short FRT intervention improve the ability to rise from kneeling, sitting, and lying positions?
- Does watching an instructional video on FRT improve fear of falling or floor-rise ability?
Study Design:
Researchers will compare:
- A group receiving 20 minutes of FRT weekly for 5 weeks.
- A control group watching FRT videos followed by discussions over the same period. Changes in floor-rise ability and FoF will be assessed to determine the effectiveness of FRT.
Participants:
Participants will be recruited from five Otago exercise classes (a falls prevention program without FRT) in Renfrewshire. Each class will be randomly assigned to either:
- The FRT intervention group (3 classes).
- The control group (2 classes) watching videos that include an FRT demonstration. Participants will complete questionnaires (to assess FoF) and timed floor-rise tests before and after the intervention. Some may also be invited to focus groups to share their experiences with the intervention, videos and with our recruitment procedures.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Scotland
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Glasgow, Scotland, United Kingdom, G4 0BA
- Glasgow Caledonian University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 or older
- Able to provide written informed consent
- Currently engaged with ROAR and attending the Otago exercise classes
Exclusion Criteria:
- Requiring a walking frame indoors to mobilise
- Have any medical condition that renders it inadvisable to descend to the floor (e.g. such as awaiting knee replacement surgery)
- Any uncontrolled medical condition requiring medical input
- BM I≥ 30 kg/m2
- Lacking capacity to consent to participate
- Unable to comprehend FRT instructions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Floor-Rise Training Group
Participants practiced getting up from the floor using a structured approach called the Backward Chaining Method (BCM).
Sessions lasted 20 minutes weekly for 5 weeks, led by an instructor.
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Practicing getting up from the floor using the Backward Chaining Method (BCM) for 20 minutes per week for 5 weeks
Other Names:
|
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Active Comparator: Video Demonstration Group
Participants watched a 20-minute instructional video called "Upwards and Onwards", available on the NHS Inform website.
The video explains how to get up from the floor safely and how to practice.
It was divided into shorter sections over 5 weeks, with group discussions ensuring a total of 20 minutes per week.
|
Watching a 20-min video on floor-rise technique and over 5 weeks, with discussions.
This video explains how to get up safely from the floor and how to practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls Efficacy Scale-International (FES-I)
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
|
A 16-item questionnaire that assesses concern about falling during daily activities.
Scores range from 16 (no concern) to 64 (severe concern).
A lower score indicates a lower fear of falling.
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Baseline and 1 week following the intervention (6 weeks post-baseline).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Floor-Rise (Supine to Standing)
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
|
Time taken (in seconds) for a participant to rise independently from a supine position (lying on their back) to a standing position using a sturdy chair.
Faster time indicates improved ability.
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Baseline and 1 week following the intervention (6 weeks post-baseline).
|
|
Timed Floor-Rise (Sitting to Standing)
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
|
Time taken (in seconds) for a participant to rise from a sitting position on the floor to standing using a sturdy chair.
Faster time indicates improved ability.
|
Baseline and 1 week following the intervention (6 weeks post-baseline).
|
|
Timed Floor-Rise (Kneeling to Standing)
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
|
Time taken (in seconds) for a participant to rise from a kneeling position to standing using a sturdy chair.
Faster time indicates improved ability.
|
Baseline and 1 week following the intervention (6 weeks post-baseline).
|
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Perceived Ability to Manage Falls (PAMF)
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
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The PAMF is a 5-item questionnaire measuring confidence in independently recovering from a fall.
Scores range from 4 to 20, with higher scores indicating greater confidence.
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Baseline and 1 week following the intervention (6 weeks post-baseline).
|
|
Fear of Falling Visual Analog Scale (VAS) - Indoor
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
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Participants mark with an "x" on a 0-100 scale measuring fear of falling indoors, with higher scores indicating greater fear.
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Baseline and 1 week following the intervention (6 weeks post-baseline).
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Fear of Falling Visual Analog Scale (VAS) - Outdoor
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
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Participants mark with an "x" on a 0-100 scale measuring fear of falling outdoors, with higher scores indicating greater fear.
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Baseline and 1 week following the intervention (6 weeks post-baseline).
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Activity Avoidance (VAS)
Time Frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
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Participants mark with an "x" on a 0-100 scale measuring the percentage of activities avoided due to fear of falling, with higher scores indicating greater avoidance.
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Baseline and 1 week following the intervention (6 weeks post-baseline).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dawn A Skelton, PhD, Glasgow Caledonian University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AHP/A23/004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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