Protocol summary

Study aim
The aim of the study is to investigate the effect of a falling safely train (FAST) course on head and hip acceleration during a fall, some gait components, and quality of life in the older adults.
Design
Randomized clinical trial, with experimental and control group, single-blind, with pre-test and post-test on 28 participants. A simple lottery method is used for randomization
Settings and conduct
The tests will be performed in a 3D motion analysis laboratory and quality of life will be assessed with a questionnaire. The exercises will be performed in gyms. For blinding, each participant will assume that everyone is doing the same activity as him.
Participants/Inclusion and exclusion criteria
Entry conditions: elderly people 60 to 70 years old; with no history of sports; with hip bone mineral density ≥-2.3 (i.e. t-score ≥-2.3); walking independently. Not entering conditions: currently undergoing physiotherapy treatment and taking anticoagulants; In the last 3 years, any injury or abnormality including any fractures or musculoskeletal surgeries, heart diseases and diabetes.
Intervention groups
The falling safely train is a progressive exercise that aims to teach how to effectively reduce impact forces during falls, change the angles of the trunk and knees during landing to reduce body acceleration, and use rolling movements to optimally distribute impact forces applied to each part of the body along the path of contact with the ground. The effect of this type of training on gait components and quality of life in the elderly is also examined. The experimental group performs the above exercises for 6 weeks but the control group only performs the pre-test and post-test.
Main outcome variables
It is predicted that head and hip acceleration during falls will decrease and gait components (step length, stride width, gait speed) and quality of life of the elderly will improve.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260602069619N1
Registration date: 2026-06-18, 1405/03/28
Registration timing: prospective

Last update: 2026-06-18, 1405/03/28
Update count: 0
Registration date
2026-06-18, 1405/03/28
Registrant information
Name
Fatemeh Khosravani
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 7734 1091
Email address
fateme9.khosravani@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-06, 1405/04/15
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a Falling Safely Training (FAST) protocol on head and hip acceleration during the fall, some components of gait and quality of life in older adults
Public title
Effect of falling safely train on older adult
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Bone mineral density of the hip ≥ −2.3 Independent walking (no use of walking aids)
Exclusion criteria:
Damage or abnormality that affecting on testing process They are currently undergoing physiotherapy treatment
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling: Lottery method. Each participant is assigned a number and written on a piece of paper. Totally 28 papers. The papers are placed in a bag. Then we take out the papers one by one randomly, the first 14 papers are placed in the experimental group and the next 14 papers are placed in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The grouping of participants into two experimental and control groups is done randomly by the researcher after the pre-test. Participants do not know which group they may be placed in during the pre-test.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kharazmi university
Street address
Next to Shahid Keshvari Sports Complex, Intersection of Kosha and Varzesh Streets, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1544733111
Approval date
2026-01-07, 1404/10/17
Ethics committee reference number
IR.KHU.REC.1404.143

Health conditions studied

1

Description of health condition studied
Prevention of fall injuries in the older adults
ICD-10 code
R29.6
ICD-10 code description
Repeated falls

Primary outcomes

1

Description
Head and hip acceleration in fall test.
Timepoint
Head and hip acceleration during a fall is measured at the beginning of the study and after 6 weeks of training to assess changes.
Method of measurement
3D motion analysis system

2

Description
Gait components include stride length, stride width, and walking speed.
Timepoint
Measurements will be taken at the beginning of the study and again after 6 weeks of training.
Method of measurement
3D motion analysis system

3

Description
Quality of life in older adults
Timepoint
The assessment will be conducted at the beginning of the study and after 6 weeks of training, again.
Method of measurement
LEIPAD Elderly Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Falling Safely Train (FAST), including rolling movements to optimally distribute impact forces applied by the ground and changing trunk and knee angles to reduce acceleration during a fall. 6 weeks of training, 2 sessions per week, 45 minutes of training per session
Category
Prevention

2

Description
Control group: This group does not receive any intervention and only takes the pre-test and post-test.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Masoud Mokhtari's Specialized Orthopedic Clinic
Full name of responsible person
Dr. Masoud Mokhtari
Street address
No. 76, Farahzadi Blvd, Book Crossroads, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1981686611
Phone
+98 900 114 4496
Fax
Email
drmokhtarimasoud@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The kharazmi university
Full name of responsible person
Seyed Sadredin Shojaedin
Street address
Next to Shahid Keshvari Sports Complex, Intersection of Kosha and Varzesh Streets, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
info@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The kharazmi university
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The Kharazmi university
Full name of responsible person
Fatemeh Khosravani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
physical trainer
Street address
No. 80, Hemmati alley, Shahed square, Tehranpars town
City
Tehran
Province
Tehran
Postal code
1656665146
Phone
+98 21 7734 1091
Email
fateme9.khosravani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The kharazmi university
Full name of responsible person
Seyed Sadredin Shojaedin
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective exercises
Street address
Next to Shahid Keshvari Sports Complex, Intersection of Kosha an varzesh Streets , Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
shojaeddin@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The Kharazmi university
Full name of responsible person
Fatemeh Khosravani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
physical trainer
Street address
No. 80, Hemmati alley, Shahed square, Tehranpars town
City
Tehran
Province
Tehran
Postal code
1656665146
Phone
+98 21 7734 1091
Email
fateme9.khosravani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect participant privacy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
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