Accidental FallsNCT07739173
Multicomponent Versus Balance Exercise for Older Adults With Recurrent Falls
A study testing Multicomponent exercise and Balance exercise in people with Accidental Falls and Recurrent Falls, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Accidental Falls, Recurrent Falls
- What is being tested?
- Multicomponent exercise and Balance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Sep 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older,
- more than two falls during the preceding year,
- unimpaired Timed Up and Go performance,
- Beck Depression Inventory score consistent with safe participation
Who cannot join
- Contraindication to exercise,
- fracture,
- cancer,
- active joint disease or infection,
- pulmonary disease,
- uncontrolled diabetes mellitus or hypertension,
- congestive heart failure, or
- serious neurological disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University Faculty of Medicine Hospital
Balıkesir, Balıkesir, 10135
About this study
Official title: Multicomponent Versus Balance Exercise for Fallrelated Physical Function in Older Adults With Recurrent Falls: a Singlecenter, Threearm Randomized Controlled Trial With 6month Followup
To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls.
- Conditions
- Accidental Falls, Recurrent Falls
- Being tested
- Multicomponent exercise, Balance exercise
- Keywords
- accidental falls, aged, exercise therapy, postural balance, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exerciseBehavioural
Supervised balance-coordination exercises and lower-extremity strengthening using elastic bands (quadriceps, hamstrings, hip abductors, hip adductors) and mini-squats.
Balance exerciseBehavioural
Supervised balance-coordination tasks, warm-up, and stretching
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise | Experimental | Supervised balance-coordination exercises followed by elastic-band strengthening of the quadriceps, hamstrings, hip abductors, and hip adductors, plus mini-squats. Sessions were delivered 3 days per week for 8 weeks. Receives: Behavioral: Multicomponent exercise |
| Balance exercise | Active comparator | Supervised balance-coordination tasks, warm-up, and stretching only, without resistance exercises or mini-squats. Sessions were delivered 3 days per week for 8 weeks. Receives: Behavioral: Balance exercise |
| Control | No intervention | Standardized education on reducing fall risk only, without any supervised exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional balance assessed by the Berg Balance Scale (BBS)
A 14-item performance-based measure used to evaluate static and dynamic balance capacity. The total score ranges from 0 to 56, where higher scores indicate better functional balance and lower fall risk.
Measured: Baseline, 8 weeks (immediately post-treatment), and 6 months (follow-up)
Secondary outcomes (3)
Maximal handgrip strength measured using a hand dynamometer
Isometric handgrip strength of the dominant/stronger hand measured in kilograms (kg) using a Jamar hydraulic hand dynamometer. Higher values indicate greater muscle strength.
Measured: Baseline, 8 weeks (post-treatment), and 6 months (follow-up)
Gait speed assessed by the 10-Meter Walk Test (10MWT)
Walking time recorded in seconds (s) over the middle 10 meters of a 14-meter walkway at comfortable walking speed. Lower time values (fewer seconds) indicate faster gait speed and improved mobility.
Measured: Baseline, 8 weeks (post-treatment), and 6 months (follow-up)
Health-related quality of life assessed by the 36-Item Short Form Survey (SF-36)
Health-related quality of life evaluated across 8 domains, with transformed subscale and summary scores ranging from 0 to 100. Higher scores indicate better health status and higher quality of life.
Measured: Baseline, 8 weeks (post-treatment), and 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Nov 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Sahin, Balikesir University
- Investigators
- Nilay Şahin, MD, Prof., Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739173
- Sponsor's protocol ID
- 2017-131-fall-thesis-zafer
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Versus Balance Exercise for Fallrelated Physical Function in Older Adults With Recurrent Falls: a Singlecenter, Threearm Randomized Controlled Trial With 6month Followup
- ClinicalTrials.gov ID
- NCT07739173
- Acronym / sponsor ID
- 2017-131-fall-thesis-zafer
- Conditions
- Accidental Falls, Recurrent Falls
- Keywords
- accidental falls, aged, exercise therapy, postural balance, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 31 Jul 2026 (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.
To compare the short-term effects and 6-month durability of supervised multicomponent exercise, balance exercise alone, and fall-prevention education on balance, strength, walking performance, and health-related quality of life in older adults with recurrent falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise | Experimental | Behavioral: Multicomponent exerciseSupervised balance-coordination exercises followed by elastic-band strengthening of the quadriceps, hamstrings, hip abductors, and hip adductors, plus mini-squats. Sessions were delivered 3 days per week for 8 weeks. |
| Balance exercise | Active comparator | Behavioral: Balance exerciseSupervised balance-coordination tasks, warm-up, and stretching only, without resistance exercises or mini-squats. Sessions were delivered 3 days per week for 8 weeks. |
| Control | No intervention | –Standardized education on reducing fall risk only, without any supervised exercise program. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older,
- more than two falls during the preceding year,
- unimpaired Timed Up and Go performance,
- Beck Depression Inventory score consistent with safe participation
Key exclusion criteria (8 listed)
- Contraindication to exercise,
- fracture,
- cancer,
- active joint disease or infection,
- pulmonary disease,
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 |
|---|---|---|
| Multicomponent exerciseSupervised balance-coordination exercises and lower-extremity strengthening using elastic bands (quadriceps, hamstrings, hip abductors, hip adductors) and mini-squats. | Behavioural | Multicomponent exercise |
| Balance exerciseSupervised balance-coordination tasks, warm-up, and stretching | Behavioural | Balance exercise |
Primary outcome
Functional balance assessed by the Berg Balance Scale (BBS)
Time frame: Baseline, 8 weeks (immediately post-treatment), and 6 months (follow-up)
A 14-item performance-based measure used to evaluate static and dynamic balance capacity. The total score ranges from 0 to 56, where higher scores indicate better functional balance and lower fall risk.
3 secondary outcomes
Maximal handgrip strength measured using a hand dynamometer
Time frame: Baseline, 8 weeks (post-treatment), and 6 months (follow-up)
Gait speed assessed by the 10-Meter Walk Test (10MWT)
Time frame: Baseline, 8 weeks (post-treatment), and 6 months (follow-up)
Health-related quality of life assessed by the 36-Item Short Form Survey (SF-36)
Time frame: Baseline, 8 weeks (post-treatment), and 6 months (follow-up)
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Nilay Şahin, MD, Prof. principal investigator
Balikesir 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 Multicomponent exercise and Balance exercise in people with Accidental Falls and Recurrent Falls, run by Balikesir University at 1 site in Turkey (Türkiye).
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 8 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 3 Aug 2026. 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 Turkey (Türkiye). 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?
Functional balance assessed by the Berg Balance Scale (BBS) (time frame: Baseline, 8 weeks (immediately post-treatment), and 6 months (follow-up)). 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 3 Aug 2026.