FallNCT05769361
Training Programs Effects on Strength and Balance in Older Adults
A study testing UNST and ST in people with Fall, run by University of Padova at 1 site in Italy.
Trial summary
Ageing involves several physiological changes such as loss of muscle mass, muscle strength, and alteration of balance control mechanisms. Consequently, there is an increased fall risk that can lead the older adult to a reduced self-sufficiency in daily living activities. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- UNST and ST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2022to 28 Apr 2023
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- self-sufficiency in daily living activities;
- aged between 65 and 85 years.
Who cannot join
- non-corrected sight disorders
- neurological disorders
- regular assumption of drugs that can interfere with normal cognitive functioning
- pathologies that contraindicate physical activity practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults
Ageing involves several physiological changes such as loss of muscle mass, muscle strength, and alteration of balance control mechanisms. Consequently, there is an increased fall risk that can lead the older adult to a reduced self-sufficiency in daily living activities. Investigating the role of different physical activities to counteract the age-related declines deserves attention. The present study aimed to evaluate the effects of two trainings performed with and without unstable devices, on dynamic balance control and lower limb strength compared to a control group that received no intervention.
Read the detailed description
The a-priori power analysis calculation reported a total sample size of 51 participants. We decided to increase the sample size of approximatively 20% hypothesizing an increment of drop-outs due to the not completely solved COVID-19 pandemic at the time of the study.
In this single-blinded randomized controlled study, both intervention groups received 24 training sessions of 45 minutes each, twice a week for 12 weeks.The two intervention groups and the control group were tested at the baseline (T0), after six weeks (T1), and after twelve weeks (T2).
Subjects of the intervention groups had to complete at least 21 out of 24 training sessions. Moreover, all subjects had to complete all the assessments. Otherwise, they were completely excluded from the data analysis.
- Conditions
- Fall
- Being tested
- UNST, ST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNSTBehavioural
Strength and balance training using different destabilizing devices
STBehavioural
Strength and balance training over firm surfaces
| Study group | Role | What they receive |
|---|---|---|
| Unstable (UNST) | Experimental | 12-week training protocol with unstable devices, twice a week. Receives: Behavioral: UNST |
| Stable (ST) | Experimental | 12-week training protocol with stable devices, twice a week Receives: Behavioral: ST |
| Control (CTRL) | No intervention | No administration of training protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Pressure (CoP) Unit Path
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:
- The mean velocity of the CoP measured in cm∙s-1 (Unit Path) over a 2.5-second time window from the beginning of the perturbation;
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Center of Pressure (CoP) Area95
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:
- The area of the 95th percentile confidence ellipse of the CoP measured in cm2 (Area95) over a 2.5-second time window from the beginning of the perturbation.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Center of Pressure (CoP) First Peak
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:
- First peak (FP) as the difference in centimeters between the peak reached by the CoP displacement after the external perturbation and the mean value of the anterior-posterior CoP displacement before the perturbation.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Center of Pressure (CoP) Maximal Oscillation
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:
- Maximal oscillation of the CoP anterior-posterior displacement as the sum in centimeters of the absolute values of FP and the subsequent peak.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Center of Pressure (CoP) Post Perturbation Variability
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:
- The standard deviation (SD) of the CoP anterior-posterior displacement over a 2.5-second time window from the beginning of the perturbation as the post perturbation variability (PPV), measured in centimeters.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Lower limb isometric strength
Isometric quadriceps maximal strength (Newton) measured with an instrumented chair. Specifically, a load cell is placed perpendicular to the subject's shank and collects the force in Newton expressed by the subject while sitting on the chair. The knee angle during the maximal effort is fixed at 90 degrees.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Secondary outcomes (2)
Timed Up and Go (TUG) test
Stand up from a chair, walk at the preferred pace to a cone at 3 meters, turn around, and walk back to the chair to sit down. The outcome is the time measured in seconds to complete the test.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
10-meter walking test
Walking 20 meters in a straight line at the preferred speed. The outcome is the time measured in seconds to complete the distance from the 5th to the 15th meter.
Measured: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start7 Mar 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769361
- Sponsor's protocol ID
- UNST2223
- Status last verified
- May 2024
- First submitted
- 11 Oct 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rizzato A, Bozzato M, Rotundo L, Zullo G, De Vito G, Paoli A, Marcolin G. Multimodal training protocols on unstable rather than stable surfaces better improve dynamic balance ability in older adults. Eur Rev Aging Phys Act. 2024 Jul 12;21(1):19. doi: 10.1186/s11556-024-00353-8.
PubMed 38997647
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults
- ClinicalTrials.gov ID
- NCT05769361
- Acronym / sponsor ID
- UNST2223
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 15 Mar 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.
Ageing involves several physiological changes such as loss of muscle mass, muscle strength, and alteration of balance control mechanisms. Consequently, there is an increased fall risk that can lead the older adult to a reduced self-sufficiency in daily living activities. Investigating the role of different physical activities to counteract the age-related declines deserves attention. The present study aimed to evaluate the effects of two trainings performed with and without unstable devices, on dynamic balance control and lower limb strength compared to a control group that received no intervention.
Detailed description
The a-priori power analysis calculation reported a total sample size of 51 participants. We decided to increase the sample size of approximatively 20% hypothesizing an increment of drop-outs due to the not completely solved COVID-19 pandemic at the time of the study.
In this single-blinded randomized controlled study, both intervention groups received 24 training sessions of 45 minutes each, twice a week for 12 weeks.The two intervention groups and the control group were tested at the baseline (T0), after six weeks (T1), and after twelve weeks (T2).
Subjects of the intervention groups had to complete at least 21 out of 24 training sessions. Moreover, all subjects had to complete all the assessments. Otherwise, they were completely excluded from the data analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unstable (UNST) | Experimental | Behavioral: UNST12-week training protocol with unstable devices, twice a week. |
| Stable (ST) | Experimental | Behavioral: ST12-week training protocol with stable devices, twice a week |
| Control (CTRL) | No intervention | –No administration of training protocols. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- self-sufficiency in daily living activities;
- aged between 65 and 85 years.
Key exclusion criteria (4 listed)
- non-corrected sight disorders
- neurological disorders
- regular assumption of drugs that can interfere with normal cognitive functioning
- pathologies that contraindicate physical activity practice
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 |
|---|---|---|
| UNSTStrength and balance training using different destabilizing devices | Behavioural | Unstable (UNST) |
| STStrength and balance training over firm surfaces | Behavioural | Stable (ST) |
Primary outcome
Center of Pressure (CoP) Unit Path
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - The mean velocity of the CoP measured in cm∙s-1 (Unit Path) over a 2.5-second time window from the beginning of the perturbation;
Center of Pressure (CoP) Area95
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - The area of the 95th percentile confidence ellipse of the CoP measured in cm2 (Area95) over a 2.5-second time window from the beginning of the perturbation.
Center of Pressure (CoP) First Peak
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - First peak (FP) as the difference in centimeters between the peak reached by the CoP displacement after the external perturbation and the mean value of the anterior-posterior CoP displacement before the perturbation.
Center of Pressure (CoP) Maximal Oscillation
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - Maximal oscillation of the CoP anterior-posterior displacement as the sum in centimeters of the absolute values of FP and the subsequent peak.
Center of Pressure (CoP) Post Perturbation Variability
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - The standard deviation (SD) of the CoP anterior-posterior displacement over a 2.5-second time window from the beginning of the perturbation as the post perturbation variability (PPV), measured in centimeters.
Lower limb isometric strength
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Isometric quadriceps maximal strength (Newton) measured with an instrumented chair. Specifically, a load cell is placed perpendicular to the subject's shank and collects the force in Newton expressed by the subject while sitting on the chair. The knee angle during the maximal effort is fixed at 90 degrees.
2 secondary outcomes
Timed Up and Go (TUG) test
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
10-meter walking test
Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
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 4 Jun 2024.
- Derived from this study: PubMed 38997647Rizzato A, Bozzato M, Rotundo L, Zullo G, De Vito G, Paoli A, Marcolin G. Multimodal training protocols on unstable rather than stable surfaces better improve dynamic balance ability in older adults. Eur Rev Aging Phys Act. 2024 Jul 12;21(1):19. doi: 10.1186/s11556-024-00353-8.
- 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.
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 UNST and ST in people with Fall, run by University of Padova 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 2 inclusion and 4 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 4 Jun 2024. 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?
Center of Pressure (CoP) Unit Path (time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)). The study lists 6 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 NCT05769361, 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 4 Jun 2024; AzTrials last refreshed its copy on 4 Nov 2026.