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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Falling
Floor-Rise Ability
Falls
Post-Fall Recovery
Older Adults (65 Years and Older)
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomization
Primary purpose: TREATMENT

Brief 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. This practice is referred to as Floor-Rise Training (FRT).

Main Questions:

1. Can a short FRT intervention reduce fear of falling?
2. Can a short FRT intervention improve the ability to rise from kneeling, sitting, and lying positions?
3. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
Secondary outcomes:
measure: Timed Floor-Rise (Supine to Standing)
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
measure: Timed Floor-Rise (Sitting to Standing)
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
measure: Timed Floor-Rise (Kneeling to Standing)
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
measure: Perceived Ability to Manage Falls (PAMF)
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
measure: Fear of Falling Visual Analog Scale (VAS) - Indoor
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
measure: Fear of Falling Visual Analog Scale (VAS) - Outdoor
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
measure: Activity Avoidance (VAS)
timeFrame: Baseline and 1 week following the intervention (6 weeks post-baseline).
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Scotland
Study officials:
affiliation: Glasgow Caledonian University
name: Dawn A Skelton, PhD
role: STUDY_DIRECTOR
References: