Accidental FallsNCT07257315
Effectiveness of a Program to Improve Balance, Mobility, and Fall Prevention in Older Adults.
A study testing Otago Exercise Program - Supervised Group and Otago Exercise Program - Home-Based in people with Accidental Falls, run by Sanidad de Castilla y León at 1 site in Spain.
Trial summary
This trial evaluates the effectiveness of the Otago Exercise Program in adults aged 65 and older. It compares supervised group-based training with an unsupervised home-based version of the same program. The primary aim is to assess changes in Timed Up and Go performance and gait speed before and after the intervention. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Otago Exercise Program - Supervised Group and Otago Exercise Program - Home-Based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2023to 3 Nov 2025
- 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
- Adults aged 65 years or older.
- Community-dwelling individuals able to ambulate independently (with or without assistive devices).
- Ability to understand instructions and follow the exercise program.
- Able to attend assessment sessions at baseline and post-intervention.
Who cannot join
- Severe cognitive impairment that limits ability to follow instructions.
- Medical conditions contraindicating exercise (e.g., unstable cardiac disease, uncontrolled hypertension).
- Recent lower-limb fracture or surgery within the last 6 months.
- Neurological conditions significantly affecting gait or balance (e.g., advanced Parkinson's disease, recent stroke).
- Participation in another structured exercise or fall-prevention program during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Program to Improve Balance, Mobility, and Fall Prevention in Older Adults: A Randomized Clinical Trial.
This trial evaluates the effectiveness of the Otago Exercise Program in adults aged 65 and older. It compares supervised group-based training with an unsupervised home-based version of the same program. The primary aim is to assess changes in Timed Up and Go performance and gait speed before and after the intervention.
Read the detailed description
This study investigates the effectiveness of the Otago Exercise Program (OEP) as a fall-prevention intervention in adults aged 65 years and older. The OEP is a structured, evidence-based program that includes strength, balance, and functional training exercises designed to reduce fall risk in older adults.
Participants will be randomly assigned to one of two groups. The experimental group will complete the Otago program in supervised group sessions led by a physiotherapist. The control group will perform the same Otago exercises individually at home without supervision, following standard instructions for independent implementation.
The primary objective of the study is to compare the effect of the supervised group-based program versus the unsupervised home-based program on functional mobility and gait performance. Primary outcomes include changes in the Timed Up and Go (TUG) test and gait speed measured before and after the intervention period.
This trial aims to determine whether supervised group training provides additional benefits over independent home-based execution of the Otago program in improving mobility and reducing fall risk among community-dwelling older adults.
- Conditions
- Accidental Falls
- Being tested
- Otago Exercise Program - Supervised Group, Otago Exercise Program - Home-Based
- Keywords
- Accidental Falls, Risk Factors, Postural Balance, Muscle Strength, Resistance Training Gait, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise Program - Supervised GroupBehavioural
Participants perform the Otago Exercise Program in supervised group sessions led by a physiotherapist. The program includes structured strength, balance, and functional exercises conducted 2-3 times per week throughout the intervention period.
Otago Exercise Program - Home-BasedBehavioural
Participants perform the same Otago Exercise Program independently at home, following standard written instructions. Exercises include strength, balance, and functional components, performed 2-3 times per week without supervision.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Group Otago Exercise Program | Experimental | Participants perform the Otago Exercise Program in supervised group sessions led by a physiotherapist. The program includes structured strength, balance, and functional exercises designed to reduce fall risk. Sessions are conducted 2-3 times per week, and participants follow the program under professional guidance throughout the intervention period. Receives: Behavioral: Otago Exercise Program - Supervised Group |
| Home-Based Otago Exercise Program | Active comparator | Participants perform the same Otago Exercise Program independently at home, following standard written instructions. The program includes the same strength, balance, and functional exercises, performed 2-3 times per week, without direct supervision from a physiotherapist. Receives: Behavioral: Otago Exercise Program - Home-Based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Functional mobility is assessed using the Timed Up and Go test. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. The time to complete the task is recorded in seconds.
Measured: Baseline and immediately after the intervention period (3 months)
Gait Speed
Walking speed is measured over a standardized distance (6 meters). The participant walks at a comfortable pace, and the time to complete the distance is recorded to calculate gait speed in meters per second.
Measured: Baseline and immediately after the intervention period (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start2 Feb 2023
- Primary completion2 Oct 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups. The experimental group performs the Otago Exercise Program in supervised group sessions led by a physiotherapist, while the control group performs the same program independently at home. Each participant remains in their assigned group for the entire duration of the intervention.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanidad de Castilla y León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Angel Delgado Gil, Sanidad de Castilla y León
- Investigators
- Jose Angel Delgado-Gil, PT (Physiotherapist), Principal investigator, Sanidad de Castilla y León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257315
- Sponsor's protocol ID
- 2395
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study team does not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Program to Improve Balance, Mobility, and Fall Prevention in Older Adults: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07257315
- Acronym / sponsor ID
- 2395
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Risk Factors, Postural Balance, Muscle Strength, Resistance Training Gait, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanidad de Castilla y LeónUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 2 Dec 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.
This trial evaluates the effectiveness of the Otago Exercise Program in adults aged 65 and older. It compares supervised group-based training with an unsupervised home-based version of the same program. The primary aim is to assess changes in Timed Up and Go performance and gait speed before and after the intervention.
Detailed description
This study investigates the effectiveness of the Otago Exercise Program (OEP) as a fall-prevention intervention in adults aged 65 years and older. The OEP is a structured, evidence-based program that includes strength, balance, and functional training exercises designed to reduce fall risk in older adults.
Participants will be randomly assigned to one of two groups. The experimental group will complete the Otago program in supervised group sessions led by a physiotherapist. The control group will perform the same Otago exercises individually at home without supervision, following standard instructions for independent implementation.
The primary objective of the study is to compare the effect of the supervised group-based program versus the unsupervised home-based program on functional mobility and gait performance. Primary outcomes include changes in the Timed Up and Go (TUG) test and gait speed measured before and after the intervention period.
This trial aims to determine whether supervised group training provides additional benefits over independent home-based execution of the Otago program in improving mobility and reducing fall risk among community-dwelling older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups. The experimental group performs the Otago Exercise Program in supervised group sessions led by a physiotherapist, while the control group performs the same program independently at home. Each participant remains in their assigned group for the entire duration of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Supervised Group Otago Exercise Program | Experimental | Behavioral: Otago Exercise Program - Supervised GroupParticipants perform the Otago Exercise Program in supervised group sessions led by a physiotherapist. The program includes structured strength, balance, and functional exercises designed to reduce fall risk. Sessions are conducted 2-3 times per week, and participants follow the program under professional guidance throughout the intervention period. |
| Home-Based Otago Exercise Program | Active comparator | Behavioral: Otago Exercise Program - Home-BasedParticipants perform the same Otago Exercise Program independently at home, following standard written instructions. The program includes the same strength, balance, and functional exercises, performed 2-3 times per week, without direct supervision from a physiotherapist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Adults aged 65 years or older.
- Community-dwelling individuals able to ambulate independently (with or without assistive devices).
- Ability to understand instructions and follow the exercise program.
- Able to attend assessment sessions at baseline and post-intervention.
Key exclusion criteria (5 listed)
- Severe cognitive impairment that limits ability to follow instructions.
- Medical conditions contraindicating exercise (e.g., unstable cardiac disease, uncontrolled hypertension).
- Recent lower-limb fracture or surgery within the last 6 months.
- Neurological conditions significantly affecting gait or balance (e.g., advanced Parkinson's disease, recent stroke).
- Participation in another structured exercise or fall-prevention program during the study period.
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 |
|---|---|---|
| Otago Exercise Program - Supervised GroupParticipants perform the Otago Exercise Program in supervised group sessions led by a physiotherapist. The program includes structured strength, balance, and functional exercises conducted 2-3 times per week throughout the intervention period. | Behavioural | Supervised Group Otago Exercise Program |
| Otago Exercise Program - Home-BasedParticipants perform the same Otago Exercise Program independently at home, following standard written instructions. Exercises include strength, balance, and functional components, performed 2-3 times per week without supervision. | Behavioural | Home-Based Otago Exercise Program |
Primary outcome
Timed Up and Go (TUG)
Time frame: Baseline and immediately after the intervention period (3 months)
Functional mobility is assessed using the Timed Up and Go test. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. The time to complete the task is recorded in seconds.
Gait Speed
Time frame: Baseline and immediately after the intervention period (3 months)
Walking speed is measured over a standardized distance (6 meters). The participant walks at a comfortable pace, and the time to complete the distance is recorded to calculate gait speed in meters per second.
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 2 Dec 2025.
- Individual participant dataSharing planned: No. The study team does not plan to share individual participant data.
Related trials for Accidental Falls
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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.
Jose Angel Delgado-Gil, PT (Physiotherapist) principal investigator
Sanidad de Castilla y León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program - Supervised Group and Otago Exercise Program - Home-Based in people with Accidental Falls, run by Sanidad de Castilla y León at 1 site in Spain.
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 4 inclusion and 5 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 2 Dec 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 Spain. 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?
Timed Up and Go (TUG) (time frame: Baseline and immediately after the intervention period (3 months)). The study lists 2 primary outcomes in all. 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 2 Dec 2025.