NCT06823882

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 7, 2025

Last Update Submit

February 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 1 week following the intervention (6 weeks post-baseline).

Secondary Outcomes (7)

  • Timed Floor-Rise (Supine to Standing)

    Baseline and 1 week following the intervention (6 weeks post-baseline).

  • Timed Floor-Rise (Sitting to Standing)

    Baseline and 1 week following the intervention (6 weeks post-baseline).

  • Timed Floor-Rise (Kneeling to Standing)

    Baseline and 1 week following the intervention (6 weeks post-baseline).

  • Perceived Ability to Manage Falls (PAMF)

    Baseline and 1 week following the intervention (6 weeks post-baseline).

  • Fear of Falling Visual Analog Scale (VAS) - Indoor

    Baseline and 1 week following the intervention (6 weeks post-baseline).

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Video Demonstration

Interventions

Practicing getting up from the floor using the Backward Chaining Method (BCM) for 20 minutes per week for 5 weeks

Also known as: Backward Chaining Method
Floor-Rise Training Group

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.

Video Demonstration Group

Eligibility Criteria

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

You may qualify if:

  • Aged 65 or older
  • Able to provide written informed consent
  • Currently engaged with ROAR and attending the Otago exercise classes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Caledonian University

Glasgow, Scotland, G4 0BA, United Kingdom

Location

Study Officials

  • Dawn A Skelton, PhD

    Glasgow Caledonian University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cluster Randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physiotherapy (DPT) Student

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 12, 2025

Study Start

January 15, 2024

Primary Completion

March 1, 2024

Study Completion

March 19, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

De-identified participant-level data for primary and secondary outcome measures

Shared Documents
STUDY PROTOCOL
Time Frame
Starting 6 months after publication and ending 5 years after publication.
Access Criteria
Qualified researchers affiliated with academic institutions will be able to access the de-identified participant-level data for primary and secondary outcome measures and study protocol by contacting the principal investigator.

Locations