Accidental FallNCT07555249
Comparative Effects Between a Resistance Training and a Combined Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults
A study testing Elastic-band resistance training and Functional and balance circuit training in people with Accidental Fall, run by University of Palermo at 1 site in Italy.
Trial summary
The aim of this study was to compare the effects of two different training protocols on muscle strength, flexibility, aerobic endurance, balance and walking ability in older adults in order to reduce their fall risk. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Elastic-band resistance training and Functional and balance circuit training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 30 May 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older Adults;
- Age ≥ 60 years;
- Independent in carrying out activities of daily living.
Who cannot join
- Unstable cardiovascular, respiratory, or neurological conditions that contraindicate exercise;
- Recent fractures, major orthopedic surgery, or acute musculoskeletal pain limiting safe exercise participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Resistance Training Versus Combined Dynamic Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults. A Randomized Controlled Trial
The aim of this study was to compare the effects of two different training protocols on muscle strength, flexibility, aerobic endurance, balance and walking ability in older adults in order to reduce their fall risk. The participants (n=110) aged 65-85 years, self-sufficient and physically active, were randomly assigned to a resistance training (RT) group and a combined balance and strength (BS) group. Both groups attended supervised sessions of 3 hours twice a week for 6 weeks. To measure the functional fitness, before and after the training program the Senior Fitness Test Battery was used, while physical activity level and fear of falling were assessed with self-reported questionnaires. Moreover, participants were asked to record the number of falls they had over the next two years after the end of the training program.
Read the detailed description
This randomized controlled trial was conducted within the Physical Activity Promotion Domestic and Accidents Prevention (PAP \& DAP) project in older adults. A total of 110 participants aged 65-85 years, independent and physically active, were randomly allocated to one of two supervised exercise programs: a resistance training (RT) group using elastic bands and a combined balance and strength (BS) group following a multi-station circuit of body-weight strengthening tasks and dynamic balance exercises. Both interventions lasted 6 weeks, with two sessions per week (3 hours/week), and all sessions were carried out by qualified exercise professionals.
Functional fitness was assessed before and after the intervention using the Senior Fitness Test battery (chair stand, arm curl, sit-and-reach, back scratch, timed up-and-go, and two-minute step test). Fear of falling was evaluated with the Short Falls Efficacy Scale-International (Short FES-I), and physical activity levels were measured using the International Physical Activity Questionnaire for Italian Elderly (IPAQ-EIT). Falls history was collected at baseline (previous 12 months), and the occurrence of at least one fall was recorded at 1- and 2-year follow-up, allowing estimation of fall incidence and crude risk ratios between groups.
The RT program focused on progressive resistance exercises for major upper- and lower-limb muscle groups using elastic bands, organized into a standardized warm-up, central training phase, and cool-down, with progression in band resistance over the 6 weeks. The BS program consisted of a fixed-order multi-station circuit including gait, stepping, and weight-shifting tasks designed to challenge vestibular, visual, muscular, and plantar components of balance, combined with lower-limb strengthening exercises. Both protocols were designed to be feasible in community settings and to target key determinants of functional independence and fall risk in older adults.
Analyses included repeated-measures ANOVA to examined significant differences within and between groups, correlations among gain scores in functional fitness variables and fear of falling, and calculation of fall incidence and risk ratios at follow-up.
- Conditions
- Accidental Fall
- Being tested
- Elastic-band resistance training, Functional and balance circuit training
- Keywords
- Postural Balance, Aged, Accidental Falls, Fear of falling, Physical Fitness, Resistance Training, Elastic Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic-band resistance trainingBehavioural
Supervised group-based resistance training with elastic bands, targeting major upper- and lower-limb muscle groups. Sessions include warm-up, a structured resistance phase with music-based exercises, and cool-down, with progressive increases in band resistance and exercise volume to improve lower-limb strength, dynamic balance, and reduce fall risk.
Functional and balance circuit trainingBehavioural
Supervised multistation circuit combining bodyweight strengthening exercises and dynamic balance tasks (e.g., directional changes, stepping, and weight-shifting activities). Sessions include warm-up, one or two rounds of the circuit, and cool-down, with progressive increases in task complexity to enhance postural control, dynamic stability, and reduce fall risk.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training group (RT) | Experimental | Participants in the Resistance Training group (RT) underwent a supervised, structured resistance training program using elastic bands, targeting the major muscle groups of the upper and lower limbs. The program was designed to progressively enhance lower-limb strength and dynamic balance through sessions including warm-up, music-based resistance exercises, and cool-down phases, ultimately aiming to reduce fall risk. Receives: Behavioral: Elastic-band resistance training |
| Balance and Strength group (BS) | Experimental | Participants in the Balance and Strength group (BS) took part in a supervised multi-station circuit combining bodyweight strengthening exercises with tasks that challenge dynamic balance (e.g., directional changes, stepping, and weight-shifting activities). The program progressively increased in difficulty across sessions to enhance postural control and dynamic stability, aiming to improve balance efficiency and reduce fall risk. Receives: Behavioral: Functional and balance circuit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fear of falling (Short FES-I score)
Fear of falling will be assessed using the Short Falls Efficacy Scale-International (Short FES-I), a 7-item self-administered questionnaire that evaluates concern about falling during basic and social daily activities. Each item is rated on a 4-point scale (1 = not at all concerned to 4 = very concerned), yielding a total score from 7 to 28, with higher scores indicating greater fear of falling. Scores will be analysed as a continuous variable and, secondarily, categorized into low concern (7-8) versus moderate/high concern (≥9).
Measured: Baseline and after 6 weeks of intervention
Lower-limb strength/endurance
Lower-limb strength and endurance will be measured using the 30-second chair stand test from the Senior Fitness Test battery, recording the number of full stands completed from a seated position in 30 seconds.
Measured: Baseline and after 6 weeks of intervention
Upper-limb strength
Upper-limb strength will be assessed with the arm curl test from the Senior Fitness Test, counting the number of elbow flexion-extension repetitions completed in 30 seconds with a standardized hand weight.
Measured: Baseline and after 6 weeks of intervention
Change in lower-back and hamstring flexibility
Flexibility of the lower back and hamstrings will be evaluated using the chair sit-and-reach test from the Senior Fitness Test, recording the distance (cm) between the extended fingers and the tip of the toe while seated.
Measured: Baseline and after 6 weeks of intervention
Change in dynamic balance and mobility
Dynamic balance and functional mobility will be measured with the Timed Up and Go test, timing in seconds how long the participant takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Measured: Baseline and after 6 weeks of intervention
Change in aerobic endurance
Aerobic endurance will be assessed using the 2-minute step test, counting the number of steps performed in place at a standardized knee height over 2 minutes, as part of the Senior Fitness Test battery.
Measured: Baseline and after 6 weeks of intervention
Relative Fall Risk
Participants were asked to record the number of falls they had over the next two years after the end of the training program and relative fall risk was calculated.
Measured: Over the next two years after the end of the training program
Secondary outcomes (1)
Change in self-reported physical activity
Self-reported physical activity will be assessed using the 7-item International Physical Activity Questionnaire for the Italian Elderly (IPAQ-EIT), which records the number of days and minutes spent walking, and in moderate and vigorous activities, as well as sedentary time over the previous week. For each intensity level, a specific MET value is assigned (walking = 3.3 METs, moderate activity = 4 METs, vigorous activity = 8 METs), and total physical activity is expressed as MET-minutes per week by summing the three components. According to total MET-minutes/week, participants will be classified as inactive (<700 MET-min/week), sufficiently active (700-2519 MET-min/week), or active/very active (≥2520 MET-min/week).
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Nov 2022
- Primary completion30 May 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Bellafiore, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555249
- Sponsor's protocol ID
- 111/2022
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) from this study will not be shared because the informed consent obtained from participants did not include permission for public data sharing and the available resources are not sufficient to ensure appropriate de-identification and data management.
Publications
Bellafiore M, Battaglia G, Bianco A, Paoli A, Farina F, Palma A. Improved postural control after dynamic balance training in older overweight women. Aging Clin Exp Res. 2011 Oct-Dec;23(5-6):378-85. doi: 10.1007/BF03337762. Epub 2010 Nov 17.
PubMed 21084833
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training Versus Combined Dynamic Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07555249
- Acronym / sponsor ID
- 111/2022
- Conditions
- Accidental Fall
- Keywords
- Postural Balance, Aged, Accidental Falls, Fear of falling, Physical Fitness, Resistance Training, Elastic Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 29 Apr 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.
The aim of this study was to compare the effects of two different training protocols on muscle strength, flexibility, aerobic endurance, balance and walking ability in older adults in order to reduce their fall risk. The participants (n=110) aged 65-85 years, self-sufficient and physically active, were randomly assigned to a resistance training (RT) group and a combined balance and strength (BS) group. Both groups attended supervised sessions of 3 hours twice a week for 6 weeks. To measure the functional fitness, before and after the training program the Senior Fitness Test Battery was used, while physical activity level and fear of falling were assessed with self-reported questionnaires. Moreover, participants were asked to record the number of falls they had over the next two years after the end of the training program.
Detailed description
This randomized controlled trial was conducted within the Physical Activity Promotion Domestic and Accidents Prevention (PAP \& DAP) project in older adults. A total of 110 participants aged 65-85 years, independent and physically active, were randomly allocated to one of two supervised exercise programs: a resistance training (RT) group using elastic bands and a combined balance and strength (BS) group following a multi-station circuit of body-weight strengthening tasks and dynamic balance exercises. Both interventions lasted 6 weeks, with two sessions per week (3 hours/week), and all sessions were carried out by qualified exercise professionals.
Functional fitness was assessed before and after the intervention using the Senior Fitness Test battery (chair stand, arm curl, sit-and-reach, back scratch, timed up-and-go, and two-minute step test). Fear of falling was evaluated with the Short Falls Efficacy Scale-International (Short FES-I), and physical activity levels were measured using the International Physical Activity Questionnaire for Italian Elderly (IPAQ-EIT). Falls history was collected at baseline (previous 12 months), and the occurrence of at least one fall was recorded at 1- and 2-year follow-up, allowing estimation of fall incidence and crude risk ratios between groups.
The RT program focused on progressive resistance exercises for major upper- and lower-limb muscle groups using elastic bands, organized into a standardized warm-up, central training phase, and cool-down, with progression in band resistance over the 6 weeks. The BS program consisted of a fixed-order multi-station circuit including gait, stepping, and weight-shifting tasks designed to challenge vestibular, visual, muscular, and plantar components of balance, combined with lower-limb strengthening exercises. Both protocols were designed to be feasible in community settings and to target key determinants of functional independence and fall risk in older adults.
Analyses included repeated-measures ANOVA to examined significant differences within and between groups, correlations among gain scores in functional fitness variables and fear of falling, and calculation of fall incidence and risk ratios at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Resistance Training group (RT) | Experimental | Behavioral: Elastic-band resistance trainingParticipants in the Resistance Training group (RT) underwent a supervised, structured resistance training program using elastic bands, targeting the major muscle groups of the upper and lower limbs. The program was designed to progressively enhance lower-limb strength and dynamic balance through sessions including warm-up, music-based resistance exercises, and cool-down phases, ultimately aiming to reduce fall risk. |
| Balance and Strength group (BS) | Experimental | Behavioral: Functional and balance circuit trainingParticipants in the Balance and Strength group (BS) took part in a supervised multi-station circuit combining bodyweight strengthening exercises with tasks that challenge dynamic balance (e.g., directional changes, stepping, and weight-shifting activities). The program progressively increased in difficulty across sessions to enhance postural control and dynamic stability, aiming to improve balance efficiency and reduce fall risk. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older Adults;
- Age ≥ 60 years;
- Independent in carrying out activities of daily living.
Key exclusion criteria (2 listed)
- Unstable cardiovascular, respiratory, or neurological conditions that contraindicate exercise;
- Recent fractures, major orthopedic surgery, or acute musculoskeletal pain limiting safe exercise participation.
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 |
|---|---|---|
| Elastic-band resistance trainingSupervised group-based resistance training with elastic bands, targeting major upper- and lower-limb muscle groups. Sessions include warm-up, a structured resistance phase with music-based exercises, and cool-down, with progressive increases in band resistance and exercise volume to improve lower-limb strength, dynamic balance, and reduce fall risk. | Behavioural | Resistance Training group (RT) |
| Functional and balance circuit trainingSupervised multistation circuit combining bodyweight strengthening exercises and dynamic balance tasks (e.g., directional changes, stepping, and weight-shifting activities). Sessions include warm-up, one or two rounds of the circuit, and cool-down, with progressive increases in task complexity to enhance postural control, dynamic stability, and reduce fall risk. | Behavioural | Balance and Strength group (BS) |
Primary outcome
Change in fear of falling (Short FES-I score)
Time frame: Baseline and after 6 weeks of intervention
Fear of falling will be assessed using the Short Falls Efficacy Scale-International (Short FES-I), a 7-item self-administered questionnaire that evaluates concern about falling during basic and social daily activities. Each item is rated on a 4-point scale (1 = not at all concerned to 4 = very concerned), yielding a total score from 7 to 28, with higher scores indicating greater fear of falling. Scores will be analysed as a continuous variable and, secondarily, categorized into low concern (7-8) versus moderate/high concern (≥9).
Lower-limb strength/endurance
Time frame: Baseline and after 6 weeks of intervention
Lower-limb strength and endurance will be measured using the 30-second chair stand test from the Senior Fitness Test battery, recording the number of full stands completed from a seated position in 30 seconds.
Upper-limb strength
Time frame: Baseline and after 6 weeks of intervention
Upper-limb strength will be assessed with the arm curl test from the Senior Fitness Test, counting the number of elbow flexion-extension repetitions completed in 30 seconds with a standardized hand weight.
Change in lower-back and hamstring flexibility
Time frame: Baseline and after 6 weeks of intervention
Flexibility of the lower back and hamstrings will be evaluated using the chair sit-and-reach test from the Senior Fitness Test, recording the distance (cm) between the extended fingers and the tip of the toe while seated.
Change in dynamic balance and mobility
Time frame: Baseline and after 6 weeks of intervention
Dynamic balance and functional mobility will be measured with the Timed Up and Go test, timing in seconds how long the participant takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Change in aerobic endurance
Time frame: Baseline and after 6 weeks of intervention
Aerobic endurance will be assessed using the 2-minute step test, counting the number of steps performed in place at a standardized knee height over 2 minutes, as part of the Senior Fitness Test battery.
Relative Fall Risk
Time frame: Over the next two years after the end of the training program
Participants were asked to record the number of falls they had over the next two years after the end of the training program and relative fall risk was calculated.
1 secondary outcome
Change in self-reported physical activity
Time frame: Baseline and after 6 weeks of intervention
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 29 Apr 2026.
- Background: PubMed 21084833Bellafiore M, Battaglia G, Bianco A, Paoli A, Farina F, Palma A. Improved postural control after dynamic balance training in older overweight women. Aging Clin Exp Res. 2011 Oct-Dec;23(5-6):378-85. doi: 10.1007/BF03337762. Epub 2010 Nov 17.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) from this study will not be shared because the informed consent obtained from participants did not include permission for public data sharing and the available resources are not sufficient to ensure appropriate de-identification and data management.
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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 Elastic-band resistance training and Functional and balance circuit training in people with Accidental Fall, run by University of Palermo at 1 site in Italy.
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 3 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 29 Apr 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 Italy. 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?
Change in fear of falling (Short FES-I score) (time frame: Baseline and after 6 weeks of intervention). The study lists 7 primary outcomes in all. 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 NCT07555249, which also lists 1 linked publication.
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 29 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.