FallNCT05835297
Effect of Specifically Developed Exercise Intervention on Falls Among Older Adults in Nursing Homes
A study testing Physical exercise interventions in people with Fall and Exercise Intervention, run by University of Pecs at 1 site in Hungary.
Trial summary
The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Exercise Intervention, Elderly Population
- What is being tested?
- Physical exercise interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHungary
- Study dates
- 25 May 2023to 31 Dec 2024
- 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
- Willingness to participate
- Males and females aged ≥65 years living in nursing homes
- Physically mobile (capable of ambulating/rising from chair with or without assistance)
- Not under simultaneous physical activity/exercise investigation in other experimental studies or under other exercise rehabilitation programme
- To be able to read and understand the self-reported assessments as well as follow the verbal instructions.
Who cannot join
- Physically unable or medically unfit to participate in physical exercise after consultation of the responsible medical team
- Score of < 18 on mini-mental state examination (MMSE).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Specifically Developed Exercise on Falls, Physical Functioning, Physical Activity, and General Physical and Psychological Well-being Among Older Adults Dwelling in Nursing Homes Following Recommendations of International Association of Gerontology and Geriatrics-Global Aging Research Network (IAGG-GARN)
The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes.
Read the detailed description
Methods: Randomized controlled trial of an individually exercise guideline recommended by IAGG-GARN for older males and females living in a nursing home. A stratified randomization will be performed after the baseline assessment. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and at 12 weeks (post-test). After baseline assessments is completed, participants will be randomly allocated to one of the two groups using stratified randomization based on equal distribution of age and gender ratio.
Expected results:
- Reduce the incidence of falls among the nursing homes residents of the intervention group (IG)
- Increase of lower extremity physical functional ability (balance, gait speed, and strength) of the IG
- Improvement of level of physical activity independency of the IG
- Improvement of functional independency of the IG
- Improvement of physical and psychological well-being among IG.
- Conditions
- Fall, Exercise Intervention, Elderly Population
- Being tested
- Physical exercise interventions
- Keywords
- Fall, Exercise, Elderly, Guideline, Risk, Functionality
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise interventionsOther
Participants will undergo a 12-week multicomponent exercise regimen, twice per week on non-consecutive days for 45-60 min each. The session will be divided into 4 min of warm-up; range of motion exercises of upper and lower extremities, followed by light walking, then 8 min balance exercises, followed by 15 min strength exercises; two sets of 13-15 repetitions maximum of chair rises with progression, two sets of 13-15 repetitions of modified squats (holding a chair backrest if needed) with progression, 2 sets of 20-30 repetitions of seated or 2 sets of 13-15 repetitions of standing calf raises, then 15 min aerobic exercises; five 3-min bouts of walking between two strengthening exercises and/or 2 balance exercises, finally 3 min cool down exercises of light walking and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Physical exercise interventions for 45 min, twice a week plus usual care provided at the nursing home. Receives: Other: Physical exercise interventions |
| Usual care | No intervention | Usual care provided at the nursing home with no specific physical exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all falls (non-injurious and injurious)
Whenever a fall occurred for any of the participants during intervention time, it will be recorded by the staff and reported on a fall incidence report. All fall will be reported; non-injurious (i.e., does not result in a physical harm), moderate injurious falls (i.e., result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days, or if the participant sought medical help), and serious injurious falls (i.e., result in a fracture or admission to hospital with an injury or required stitches).
Measured: During the 12-week of the intervention.
Secondary outcomes (14)
Short Physical Performance Battery (SPPB)
An instrument to test the lower extremity functionality, it consists of 3 types of balance tests (side-by-side stand, semi-tandem stand, tandem stand), a 4-m gait speed test, and a chair sit-to-stand test. Each domain is scored between 0 and 4 and the overall score ranges from 0 (low mobility/functionality) to 12 (full mobility/ functionality).
Measured: Baseline and 12th week.
Six-minute Walking Test (6MWT)
A timed walk test used to evaluate physical function related to lower extremities strength and mobility. Participants will walk the longest distance possible within 6 min. The outcome is the total walking distance in meters, with higher score indicates better performance.
Measured: Baseline and 12th week.
Timed Up and Go Test (TUGT)
A test to measure functional mobility. The outcome measure will be time in seconds, taken to stand up from a chair, walk 3 m, turn, return to the chair, and sit down. Lower score indicates better performance.
Measured: Baseline and 12th week.
Single Leg Stance Test (SLST)
A test to evaluate the static balance capability. Participants will be asked to stand barefoot on 1leg with eyes open on firm surface for as long as possible; the time in seconds will be recorded using a stopwatch. The participants will complete 3 trials on each leg, and a mean score will be calculated for each leg.
Measured: Baseline and 12th week.
Functional Reach Test (FRT)
A test to evaluate dynamic balance through measuring the maximal distance participants are able to reach forward while standing or sitting on a chair. 3 trials are done and the average of the last two is noted, with longer distance to reach forward indicates better performance.
Measured: Baseline and 12th week.
Mini-mental State Examination (MMSE)
A tool used to evaluate cognitive function (scored from 0 to 30; scores below 24 indicate cognitive impairment) through 11 items.
Measured: Baseline and 12th week.
Barthel Index
A tool is used to record the independence of participants when performing basic activities of daily living (ADLs) via ten items. Feeding, personal toileting, bathing, dressing, and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs are rated on a scale from 0 to 15 points depending on the item. Total possible scores range from 0 (totally dependent) to 100 (fully independent).
Measured: Baseline and 12th week.
World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
A self-administered questionnaire consists of 26 items, evaluating participants' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".
Measured: Baseline and 12th week.
World Health Organization Well-Being Index (WHO-5)
A self-reported rating scale of 5 items, measuring subjective psychological well-being.
The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25.To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.
Measured: Baseline and 12th week.
Geriatrics Depression Scale (GDS)
A self-rated depression scale of 15 items, that identify symptoms of depression in older adults. A score of ≥ 5 suggests depression.
Measured: Baseline and 12th week.
Beck Depression Inventory (BDI-13)
A 13-question multiple-choice self-report inventory for measuring the severity of depression. A score of ≥ 7 indicates mild depression.
Measured: Baseline and 12th week.
Pittsburgh Sleep Quality Index (PSQI)
A self-reported scale for measuring patterns and quality of sleep in adults via 19 items. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower score indicates a healthier sleep quality.
Measured: Baseline and 12th week.
Global Physical Activity Questionnaire (GPAQ)
The GPAQ version 2 developed by WHO will be used. It comprises 16 self-administered questions that collect information on physical activity in three settings (or domains) as well as sedentary behaviour of a week (7 days).
Measured: Baseline and 12th week.
Sedentary Behaviour Questionnaire (SBQ)
A self-reported assessment of the amount of time spent doing 9 behaviours separately for weekdays and weekend days. (watching television, playing on a computer/video game, sitting while listening to music, sitting and talking on the phone, doing paperwork or office work, sitting and was reading, playing a musical instrument, doing arts and crafts, sitting and driving/riding in a car, bus, or train).
Scoring:
- Convert all times into hours (e.g. a response of 15 minutes or less is recoded as 0.25 and 30 minutes is recoded as 0.5).
- For total scores of sedentary behavior, sum the hours per day separately for weekday and weekend items.
- To obtain weekly estimates, weekday hours are multiplied by 5 and weekend hours are multiplied by 2 and these are summed for total hours per week.
- Estimates over 24 hours per day are truncated to 24 hours per day
Measured: Baseline and 12th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start25 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munseef Sadaqa, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835297
- Sponsor's protocol ID
- 9283 - PTE 2022
- Status last verified
- Mar 2024
- First submitted
- 17 Apr 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sadaqa M, Debes WA, Nemeth Z, Bera-Baka Z, Vachtler-Szepesi M, Foldes LN, Premusz V, Hock M. Multicomponent exercise intervention for preventing falls and improving physical functioning in older adult nursing home residents: study protocol for a randomised controlled trial. BMC Public Health. 2025 Oct 2;25(1):3296. doi: 10.1186/s12889-025-24606-y.
PubMed 41039429Sadaqa M, Debes WA, Nemeth Z, Bera-Baka Z, Vachtler-Szepesi M, Naczine Foldes L, Premusz V, Hock M. Multicomponent Exercise Intervention for Preventing Falls and Improving Physical Functioning in Older Nursing Home Residents: A Single-Blinded Pilot Randomised Controlled Trial. J Clin Med. 2024 Mar 10;13(6):1577. doi: 10.3390/jcm13061577.
PubMed 38541803
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specifically Developed Exercise on Falls, Physical Functioning, Physical Activity, and General Physical and Psychological Well-being Among Older Adults Dwelling in Nursing Homes Following Recommendations of International Association of Gerontology and Geriatrics-Global Aging Research Network (IAGG-GARN)
- ClinicalTrials.gov ID
- NCT05835297
- Acronym / sponsor ID
- 9283 - PTE 2022
- Conditions
- Fall, Exercise Intervention, Elderly Population
- Keywords
- Fall, Exercise, Elderly, Guideline, Risk, Functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Apr 2023 (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.
The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes.
Detailed description
Methods: Randomized controlled trial of an individually exercise guideline recommended by IAGG-GARN for older males and females living in a nursing home. A stratified randomization will be performed after the baseline assessment. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and at 12 weeks (post-test). After baseline assessments is completed, participants will be randomly allocated to one of the two groups using stratified randomization based on equal distribution of age and gender ratio.
Expected results:
- Reduce the incidence of falls among the nursing homes residents of the intervention group (IG)
- Increase of lower extremity physical functional ability (balance, gait speed, and strength) of the IG
- Improvement of level of physical activity independency of the IG
- Improvement of functional independency of the IG
- Improvement of physical and psychological well-being among IG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Physical exercise interventionsPhysical exercise interventions for 45 min, twice a week plus usual care provided at the nursing home. |
| Usual care | No intervention | –Usual care provided at the nursing home with no specific physical exercise intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Willingness to participate
- Males and females aged ≥65 years living in nursing homes
- Physically mobile (capable of ambulating/rising from chair with or without assistance)
- Not under simultaneous physical activity/exercise investigation in other experimental studies or under other exercise rehabilitation programme
- To be able to read and understand the self-reported assessments as well as follow the verbal instructions.
Key exclusion criteria (2 listed)
- Physically unable or medically unfit to participate in physical exercise after consultation of the responsible medical team
- Score of < 18 on mini-mental state examination (MMSE).
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 |
|---|---|---|
| Physical exercise interventionsParticipants will undergo a 12-week multicomponent exercise regimen, twice per week on non-consecutive days for 45-60 min each. The session will be divided into 4 min of warm-up; range of motion exercises of upper and lower extremities, followed by light walking, then 8 min balance exercises, followed by 15 min strength exercises; two sets of 13-15 repetitions maximum of chair rises with progression, two sets of 13-15 repetitions of modified squats (holding a chair backrest if needed) with progression, 2 sets of 20-30 repetitions of seated or 2 sets of 13-15 repetitions of standing calf raises, then 15 min aerobic exercises; five 3-min bouts of walking between two strengthening exercises and/or 2 balance exercises, finally 3 min cool down exercises of light walking and stretching exercises. | Other | Exercise group |
Primary outcome
Number of all falls (non-injurious and injurious)
Time frame: During the 12-week of the intervention.
Whenever a fall occurred for any of the participants during intervention time, it will be recorded by the staff and reported on a fall incidence report. All fall will be reported; non-injurious (i.e., does not result in a physical harm), moderate injurious falls (i.e., result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days, or if the participant sought medical help), and serious injurious falls (i.e., result in a fracture or admission to hospital with an injury or required stitches).
14 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline and 12th week.
Six-minute Walking Test (6MWT)
Time frame: Baseline and 12th week.
Timed Up and Go Test (TUGT)
Time frame: Baseline and 12th week.
Single Leg Stance Test (SLST)
Time frame: Baseline and 12th week.
Functional Reach Test (FRT)
Time frame: Baseline and 12th week.
Mini-mental State Examination (MMSE)
Time frame: Baseline and 12th week.
Barthel Index
Time frame: Baseline and 12th week.
World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
Time frame: Baseline and 12th week.
World Health Organization Well-Being Index (WHO-5)
Time frame: Baseline and 12th week.
Geriatrics Depression Scale (GDS)
Time frame: Baseline and 12th week.
Beck Depression Inventory (BDI-13)
Time frame: Baseline and 12th week.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 12th week.
Global Physical Activity Questionnaire (GPAQ)
Time frame: Baseline and 12th week.
Sedentary Behaviour Questionnaire (SBQ)
Time frame: Baseline and 12th week.
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 9 Jan 2025.
- Derived from this study: PubMed 41039429Sadaqa M, Debes WA, Nemeth Z, Bera-Baka Z, Vachtler-Szepesi M, Foldes LN, Premusz V, Hock M. Multicomponent exercise intervention for preventing falls and improving physical functioning in older adult nursing home residents: study protocol for a randomised controlled trial. BMC Public Health. 2025 Oct 2;25(1):3296. doi: 10.1186/s12889-025-24606-y.
- Derived from this study: PubMed 38541803Sadaqa M, Debes WA, Nemeth Z, Bera-Baka Z, Vachtler-Szepesi M, Naczine Foldes L, Premusz V, Hock M. Multicomponent Exercise Intervention for Preventing Falls and Improving Physical Functioning in Older Nursing Home Residents: A Single-Blinded Pilot Randomised Controlled Trial. J Clin Med. 2024 Mar 10;13(6):1577. doi: 10.3390/jcm13061577.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise interventions in people with Fall and Exercise Intervention, run by University of Pecs at 1 site in Hungary.
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 5 inclusion and 2 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 9 Jan 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 Hungary. 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?
Number of all falls (non-injurious and injurious) (time frame: During the 12-week of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05835297, which also lists 2 linked publications.
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 9 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.