Frail Elderly SyndromeNCT05940779
Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial.
A study testing Therapeutic exercise program in people with Frail Elderly Syndrome and Fall, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Fall
- What is being tested?
- Therapeutic exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 22 Sep 2021to 30 Sep 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
- Community dwelling older adults.
- Independent for ambulation.
- With a cognitive state that do not prevent understand the researcher indications.
- Not performing regular physical exercise (only basic activities of daily living, but no other type of intervention).
Who cannot join
- Contraindication of physical exercise.
- Evident impaired cognitive state.
- Vestibular or central nervous system affection.
- Can´t speak and understand spanish correctly.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, 46010
José María Blasco Igual, 963983855, Jose.Maria.Blasco@uv.es
About this study
The goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. The main questions it aims to answer are:
- If the therapeutic exercise program proposed is a successful treatment for this kind of patients
- If patients at risk of falls also suffer from pre-frailty or frailty, and if they can be treated together with the proposed therapy.
Read more
Participants will follow a program consisting of exercises to correct posture, gain strength and contribute to greater balance.
Researchers will compare the therapy and control groups to see if the program increases the percentage of muscle mass of participants, their mobility, balance, quality of life and if they reduce their Fried´s frailty criteria, fear of falling and falls compared to their usual physical activity.
- Conditions
- Frail Elderly Syndrome, Fall
- Being tested
- Therapeutic exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise programOther
The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Other: Therapeutic exercise program |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Measured: Assessed before the first intervention (baseline).
Timed Up and Go (TUG)
Measured: Assessed after the first intervention (3 months later).
Timed Up and Go (TUG)
Measured: Assessed after the second intervention (3 months after the previous assessement).
Timed Up and Go (TUG)
Measured: Assessed after 3 months from the previous assessement.
Fried frailty criteria
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Measured: Assessed before the first intervention (baseline).
Fried frailty criteria
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Measured: Assessed after the first intervention (3 months later).
Fried frailty criteria
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Measured: Assessed after the second intervention (3 months after the previous assessement).
Fried frailty criteria
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Measured: Assessed after 3 months from the previous assessement.
Secondary outcomes (18)
Falls and their consequences
The number of falls in the last year will be asked.
Measured: Assessed before the first intervention (baseline).
Falls and their consequences
A follow-up made with phone calls.
Measured: Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Measured: Assessed before the first intervention (baseline).
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Measured: Assessed after the first intervention (3 months later).
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Measured: Assessed after the second intervention (3 months after the previous assessement).
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Measured: Assessed after 3 months from the previous assessement.
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Measured: Assessed before the first intervention (baseline).
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Measured: Assessed after the first intervention (3 months later).
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Measured: Assessed after the second intervention (3 months after the previous assessement).
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Measured: Assessed after 3 months from the previous assessement.
European Quality of Life-5 Dimensions (EuroQol-5D)
It has two parts:
The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.
The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Measured: Assessed before the first intervention (baseline).
European Quality of Life-5 Dimensions (EuroQol-5D)
It has two parts:
The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.
The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Measured: Assessed after the first intervention (3 months later).
European Quality of Life-5 Dimensions (EuroQol-5D)
It has two parts:
The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.
The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Measured: Assessed after the second intervention (3 months after the previous assessement).
European Quality of Life-5 Dimensions (EuroQol-5D)
It has two parts:
The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.
The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Measured: Assessed after 3 months from the previous assessement.
Muscle mass
Assessed with and impedance scale.
Measured: Assessed before the first intervention (baseline).
Muscle mass
Assessed with and impedance scale.
Measured: Assessed after the first intervention (3 months later).
Muscle mass
Assessed with and impedance scale.
Measured: Assessed after the second intervention (3 months after the previous assessement).
Muscle mass
Assessed with and impedance scale.
Measured: Assessed after 3 months from the previous assessement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start22 Sep 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940779
- Sponsor's protocol ID
- H1504602336419
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT05940779
- Acronym / sponsor ID
- H1504602336419
- Conditions
- Frail Elderly Syndrome, Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Jul 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 goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. The main questions it aims to answer are:
- If the therapeutic exercise program proposed is a successful treatment for this kind of patients
- If patients at risk of falls also suffer from pre-frailty or frailty, and if they can be treated together with the proposed therapy.
Participants will follow a program consisting of exercises to correct posture, gain strength and contribute to greater balance.
Researchers will compare the therapy and control groups to see if the program increases the percentage of muscle mass of participants, their mobility, balance, quality of life and if they reduce their Fried´s frailty criteria, fear of falling and falls compared to their usual physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Therapeutic exercise program |
| Control group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community dwelling older adults.
- Independent for ambulation.
- With a cognitive state that do not prevent understand the researcher indications.
- Not performing regular physical exercise (only basic activities of daily living, but no other type of intervention).
Key exclusion criteria (4 listed)
- Contraindication of physical exercise.
- Evident impaired cognitive state.
- Vestibular or central nervous system affection.
- Can´t speak and understand spanish correctly.
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 |
|---|---|---|
| Therapeutic exercise programThe intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture. | Other | Exercise group |
Primary outcome
Timed Up and Go (TUG)
Time frame: Assessed before the first intervention (baseline).
Timed Up and Go (TUG)
Time frame: Assessed after the first intervention (3 months later).
Timed Up and Go (TUG)
Time frame: Assessed after the second intervention (3 months after the previous assessement).
Timed Up and Go (TUG)
Time frame: Assessed after 3 months from the previous assessement.
Fried frailty criteria
Time frame: Assessed before the first intervention (baseline).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Fried frailty criteria
Time frame: Assessed after the first intervention (3 months later).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Fried frailty criteria
Time frame: Assessed after the second intervention (3 months after the previous assessement).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Fried frailty criteria
Time frame: Assessed after 3 months from the previous assessement.
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
18 secondary outcomes
Falls and their consequences
Time frame: Assessed before the first intervention (baseline).
Falls and their consequences
Time frame: Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
Berg Balance Scale (BBS)
Time frame: Assessed before the first intervention (baseline).
Berg Balance Scale (BBS)
Time frame: Assessed after the first intervention (3 months later).
Berg Balance Scale (BBS)
Time frame: Assessed after the second intervention (3 months after the previous assessement).
Berg Balance Scale (BBS)
Time frame: Assessed after 3 months from the previous assessement.
Falls Efficacy Scale-International (FES-I)
Time frame: Assessed before the first intervention (baseline).
Falls Efficacy Scale-International (FES-I)
Time frame: Assessed after the first intervention (3 months later).
Falls Efficacy Scale-International (FES-I)
Time frame: Assessed after the second intervention (3 months after the previous assessement).
Falls Efficacy Scale-International (FES-I)
Time frame: Assessed after 3 months from the previous assessement.
European Quality of Life-5 Dimensions (EuroQol-5D)
Time frame: Assessed before the first intervention (baseline).
European Quality of Life-5 Dimensions (EuroQol-5D)
Time frame: Assessed after the first intervention (3 months later).
European Quality of Life-5 Dimensions (EuroQol-5D)
Time frame: Assessed after the second intervention (3 months after the previous assessement).
European Quality of Life-5 Dimensions (EuroQol-5D)
Time frame: Assessed after 3 months from the previous assessement.
Muscle mass
Time frame: Assessed before the first intervention (baseline).
Muscle mass
Time frame: Assessed after the first intervention (3 months later).
Muscle mass
Time frame: Assessed after the second intervention (3 months after the previous assessement).
Muscle mass
Time frame: Assessed after 3 months from the previous assessement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise program in people with Frail Elderly Syndrome and Fall, run by University of Valencia at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belén Quel Tejón (675760137, bequelte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: Assessed before the first intervention (baseline).). The study lists 8 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 11 Jul 2023.