Fear of FallingNCT06823882
Practicing Getting Up From the Floor to Reduce Fear of Falling and Improve Floor-Rise Ability in Community-Dwelling Older Adults: A Pilot Study
A study testing Floor-Rise Training and Video Demonstration in people with Fear of Falling and Floor-Rise Ability, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fear of Falling, Floor-Rise Ability, Falls
- What is being tested?
- Floor-Rise Training and Video Demonstration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2024to 19 Mar 2024
- 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
- Aged 65 or older
- Able to provide written informed consent
- Currently engaged with ROAR and attending the Otago exercise classes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Caledonian University
Glasgow, Scotland, G4 0BA
About this study
Official title: 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).
Read more
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.
- Conditions
- Fear of Falling, Floor-Rise Ability, Falls, Post-Fall Recovery, Older Adults (65 Years and Older)
- Being tested
- Floor-Rise Training, Video Demonstration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floor-Rise TrainingBehavioural
Also called Backward Chaining Method
Practicing getting up from the floor using the Backward Chaining Method (BCM) for 20 minutes per week for 5 weeks
Video DemonstrationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Floor-Rise Training Group | Experimental | 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. Receives: Behavioral: Floor-Rise Training |
| Video Demonstration Group | Active comparator | 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. Receives: Behavioral: Video Demonstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Efficacy Scale-International (FES-I)
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.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Secondary outcomes (7)
Timed Floor-Rise (Supine to Standing)
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.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Timed Floor-Rise (Sitting to Standing)
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.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Timed Floor-Rise (Kneeling to Standing)
Time taken (in seconds) for a participant to rise from a kneeling position to standing using a sturdy chair. Faster time indicates improved ability.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Perceived Ability to Manage Falls (PAMF)
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.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Fear of Falling Visual Analog Scale (VAS) - Indoor
Participants mark with an "x" on a 0-100 scale measuring fear of falling indoors, with higher scores indicating greater fear.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Fear of Falling Visual Analog Scale (VAS) - Outdoor
Participants mark with an "x" on a 0-100 scale measuring fear of falling outdoors, with higher scores indicating greater fear.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Activity Avoidance (VAS)
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.
Measured: Baseline and 1 week following the intervention (6 weeks post-baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start15 Jan 2024
- Primary completion1 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of FallingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomization
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shane Seeley, Glasgow Caledonian University
- Investigators
- Dawn A Skelton, PhD, Study director, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823882
- Sponsor's protocol ID
- AHP/A23/004
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data for primary and secondary outcome measures
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06823882
- Acronym / sponsor ID
- AHP/A23/004
- Conditions
- Fear of Falling, Floor-Rise Ability, Falls, Post-Fall Recovery, Older Adults (65 Years and Older)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 12 Feb 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomization
| Arm | Type | Receives |
|---|---|---|
| Floor-Rise Training Group | Experimental | Behavioral: Floor-Rise TrainingParticipants 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. |
| Video Demonstration Group | Active comparator | Behavioral: Video DemonstrationParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 or older
- Able to provide written informed consent
- Currently engaged with ROAR and attending the Otago exercise classes
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Floor-Rise TrainingAlso: Backward Chaining MethodPracticing getting up from the floor using the Backward Chaining Method (BCM) for 20 minutes per week for 5 weeks | Behavioural | Floor-Rise Training Group |
| Video DemonstrationWatching 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. | Behavioural | Video Demonstration Group |
Primary outcome
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.
7 secondary outcomes
Timed Floor-Rise (Supine to Standing)
Time frame: 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).
Timed Floor-Rise (Kneeling to Standing)
Time frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
Perceived Ability to Manage Falls (PAMF)
Time frame: 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).
Fear of Falling Visual Analog Scale (VAS) - Outdoor
Time frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
Activity Avoidance (VAS)
Time frame: Baseline and 1 week following the intervention (6 weeks post-baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Yes. De-identified participant-level data for primary and secondary outcome measures
Related trials for Fear of Falling
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
Effects of Otago Exercise Combined With Short-Foot Exercise in Older Adults
Aging
Not yet recruitingObservational study
Fear of Falling in Stroke: Its Relationship With Motor Recovery, Stroke Duration, Trunk Control, and Balance
Stroke
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.
Dawn A Skelton, PhD study director
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floor-Rise Training and Video Demonstration in people with Fear of Falling and Floor-Rise Ability, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Efficacy Scale-International (FES-I) (time frame: Baseline and 1 week following the intervention (6 weeks post-baseline).). 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 12 Feb 2025.