Frailty SyndromeNCT06731712
Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults
A study testing Physical Function Exercises in people with Frailty Syndrome and Pre-frail Older Adults, run by Hellenic Mediterranean University at 1 site in Greece.
Trial summary
The investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty Syndrome, Pre-frail Older Adults
- What is being tested?
- Physical Function Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteGreece
- Study dates
- 15 Dec 2022to 15 Jun 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
- participants aged 65 and over
- classified as pre-frail according to SHARE-Frailty Instrument
- independent of movement and activity
- able to perform Mini-Mental Status Examination (MMSE) score ≥24
Who cannot join
- severe contraindications for physical exercise
- central nervous system impairments
- inability to speak and understand Greek properly
- a cognitive state that prevents understanding the researcher's instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults: a Randomized Controlled Trial
The investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment.
The hypothesis of this study is to investigate the impact of targeted physical function exercises on managing frailty status and concerns about falling among pre-frail older adults. By implementing individualized intervention programs tailored to improve strength, balance, and mobility, the investigators aim to enhance physical function and reduce the risk of frailty-related adverse health outcomes. The investigators seek to empower pre-frail older adults to proactively manage their health, maintain independence, and improve their quality of life as they age.
- Conditions
- Frailty Syndrome, Pre-frail Older Adults
- Being tested
- Physical Function Exercises
- Keywords
- Frailty, Concerns about Falling, Physical Function exercises
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Function ExercisesOther
Also called Targeted Physical Function Exercises
Physical function interventions included strength, balance, and mobility exercises. More specifically, the exercises include progressively increasing intensity strengthening exercises with a resistance band for the following muscle groups: hip abductor and extensor muscles, knee flexor and extensor muscles, and shoulder abductor and external rotator muscles. Other exercises consist of standing calf raises, squats, bridges, and push-ups. Additionally, functional exercises include heel-to-toe standing or walking, single-leg standing, stepping over obstacles, bending down, and lifting an object with feet together.
| Study group | Role | What they receive |
|---|---|---|
| Physical Function Group | Experimental | Physical function interventions including strength, balance, and mobility exercises Receives: Other: Physical Function Exercises |
| Control Group | No intervention | Will continue their normal lives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Frailty status
SHARE Frailty Instrument will be used. Diagnostic criteria include involuntary loss of weight and muscle mass, exhaustion, low physical activity, slowness, and reduced grip strength. The presence of three or more criteria indicates frailty, while the presence of less than three pre-frailty
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Concerns about Falling
The Falls Efficacy Scale - International (FES-I), a 16-item questionnaire that assesses the participant's fall efficacy, will be used to measure the level of concern about falling during various social and physical activities. Every item has a four-point (1-4) score, summarizing a total score of 64 points. A 16-22 score indicates low concern about falling, and a 23-64 high concern.
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Secondary outcomes (5)
Physical Performance
The Short Physical Performance Battery (SPPB) will be used to assess physical performance. It is an assessment tool consisting of 3 tests in three different domains (walking, sit-to-stand, and balance) to assess function: a 3- or 4-meter walking time at the usual speed, one single chair stand, and time to complete five chair stands, and three balance tests of progressive difficulty, holding for 10 seconds (side-by-side, semi-tandem, tandem stand). Each test is rated on a scale of 0 to 4, summed to give an overall score ranging from 0 to 12, with a higher score indicating better performance.
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Functional Mobility
For quantifying functional mobility, the Time Up and Go test (TUG) will be used. Participants will be observed and timed while standing up from an armchair, walking three meters, making a turn, and returning to their sitting position. The timer will start when the participants are ready to stand up and stop when they return sitter.
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Functional Balance
The Berg Balance Scale (BBS) will be used to assess a participant's ability to balance safely during specific tasks. It evaluates dynamic and static balance through 14 functional tasks, with each task answered on a five-point scale ranging from 0, indicating the lowest level of functioning, to 4, the highest level of functioning. The final summary score ranges from 0 to 56.
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Quality of Daily Living
To assess the quality of life of the participants, the WHOQOL-BREF scale will be used, which includes 26 items concerning 4 domains of health (physical health, psychological health, social relationships, and environment) and 4 additional items concerning nutrition, satisfaction with work, home life, and social life. Each item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100 scale.
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Depression
The short-form Geriatric Depression Scale (GDS), consisting of 15 yes-or-no questions with a total score range of 0 to 15, was used to assess the participant's depressive symptoms. A score of 0 to 5 is normal. A score greater than 5 suggests depression.
Measured: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start15 Dec 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Giakoumidakis, Hellenic Mediterranean University
- Investigators
- Konstantinos Giakoumidakis, Principal investigator, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731712
- Sponsor's protocol ID
- 3589/2020
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06731712
- Acronym / sponsor ID
- 3589/2020
- Conditions
- Frailty Syndrome, Pre-frail Older Adults
- Keywords
- Frailty, Concerns about Falling, Physical Function exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 12 Dec 2024 (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 investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment.
The hypothesis of this study is to investigate the impact of targeted physical function exercises on managing frailty status and concerns about falling among pre-frail older adults. By implementing individualized intervention programs tailored to improve strength, balance, and mobility, the investigators aim to enhance physical function and reduce the risk of frailty-related adverse health outcomes. The investigators seek to empower pre-frail older adults to proactively manage their health, maintain independence, and improve their quality of life as they age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Function Group | Experimental | Other: Physical Function ExercisesPhysical function interventions including strength, balance, and mobility exercises |
| Control Group | No intervention | –Will continue their normal lives |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- participants aged 65 and over
- classified as pre-frail according to SHARE-Frailty Instrument
- independent of movement and activity
- able to perform Mini-Mental Status Examination (MMSE) score ≥24
Key exclusion criteria (4 listed)
- severe contraindications for physical exercise
- central nervous system impairments
- inability to speak and understand Greek properly
- a cognitive state that prevents understanding the researcher's instructions
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 Function ExercisesAlso: Targeted Physical Function ExercisesPhysical function interventions included strength, balance, and mobility exercises. More specifically, the exercises include progressively increasing intensity strengthening exercises with a resistance band for the following muscle groups: hip abductor and extensor muscles, knee flexor and extensor muscles, and shoulder abductor and external rotator muscles. Other exercises consist of standing calf raises, squats, bridges, and push-ups. Additionally, functional exercises include heel-to-toe standing or walking, single-leg standing, stepping over obstacles, bending down, and lifting an object with feet together. | Other | Physical Function Group |
Primary outcome
Level of Frailty status
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
SHARE Frailty Instrument will be used. Diagnostic criteria include involuntary loss of weight and muscle mass, exhaustion, low physical activity, slowness, and reduced grip strength. The presence of three or more criteria indicates frailty, while the presence of less than three pre-frailty
Concerns about Falling
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
The Falls Efficacy Scale - International (FES-I), a 16-item questionnaire that assesses the participant's fall efficacy, will be used to measure the level of concern about falling during various social and physical activities. Every item has a four-point (1-4) score, summarizing a total score of 64 points. A 16-22 score indicates low concern about falling, and a 23-64 high concern.
5 secondary outcomes
Physical Performance
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Functional Mobility
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Functional Balance
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Quality of Daily Living
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
Depression
Time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
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 12 Dec 2024.
- 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.
Konstantinos Giakoumidakis principal investigator
Hellenic Mediterranean 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 Physical Function Exercises in people with Frailty Syndrome and Pre-frail Older Adults, run by Hellenic Mediterranean University at 1 site in Greece.
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 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 12 Dec 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 Greece. 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?
Level of Frailty status (time frame: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).). 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 12 Dec 2024.