Clinical trial NCT05940779: 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.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Fall
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Contraindication of physical exercise.
* Evident impaired cognitive state.
* Vestibular or central nervous system affection.
* Can´t speak and understand spanish correctly.

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Assessed before the first intervention (baseline).
measure: Timed Up and Go (TUG)
timeFrame: Assessed after the first intervention (3 months later).
measure: Timed Up and Go (TUG)
timeFrame: Assessed after the second intervention (3 months after the previous assessement).
measure: Timed Up and Go (TUG)
timeFrame: Assessed after 3 months from the previous assessement.
measure: Fried frailty criteria
timeFrame: Assessed before the first intervention (baseline).
measure: Fried frailty criteria
timeFrame: Assessed after the first intervention (3 months later).
measure: Fried frailty criteria
timeFrame: Assessed after the second intervention (3 months after the previous assessement).
measure: Fried frailty criteria
timeFrame: Assessed after 3 months from the previous assessement.
Secondary outcomes:
measure: Falls and their consequences
timeFrame: Assessed before the first intervention (baseline).
measure: Falls and their consequences
timeFrame: Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
measure: Berg Balance Scale (BBS)
timeFrame: Assessed before the first intervention (baseline).
measure: Berg Balance Scale (BBS)
timeFrame: Assessed after the first intervention (3 months later).
measure: Berg Balance Scale (BBS)
timeFrame: Assessed after the second intervention (3 months after the previous assessement).
measure: Berg Balance Scale (BBS)
timeFrame: Assessed after 3 months from the previous assessement.
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Assessed before the first intervention (baseline).
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Assessed after the first intervention (3 months later).
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Assessed after the second intervention (3 months after the previous assessement).
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Assessed after 3 months from the previous assessement.
measure: European Quality of Life-5 Dimensions (EuroQol-5D)
timeFrame: Assessed before the first intervention (baseline).
measure: European Quality of Life-5 Dimensions (EuroQol-5D)
timeFrame: Assessed after the first intervention (3 months later).
measure: European Quality of Life-5 Dimensions (EuroQol-5D)
timeFrame: Assessed after the second intervention (3 months after the previous assessement).
measure: European Quality of Life-5 Dimensions (EuroQol-5D)
timeFrame: Assessed after 3 months from the previous assessement.
measure: Muscle mass
timeFrame: Assessed before the first intervention (baseline).
measure: Muscle mass
timeFrame: Assessed after the first intervention (3 months later).
measure: Muscle mass
timeFrame: Assessed after the second intervention (3 months after the previous assessement).
measure: Muscle mass
timeFrame: Assessed after 3 months from the previous assessement.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References: