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.

University of Valencia40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Frail Elderly Syndrome Fall

Interventions

The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Valencia

Valencia, Spain

RECRUITING

Outcomes

Primary Outcomes

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

The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Assessed after 3 months from the previous assessement.

Secondary Outcomes

Falls and their consequences

The number of falls in the last year will be asked.

Time frame: Assessed before the first intervention (baseline).

Falls and their consequences

A follow-up made with phone calls.

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)

From 0 to 56. It shows a better balance when the score is higher.

Time frame: Assessed before the first intervention (baseline).

Berg Balance Scale (BBS)

From 0 to 56. It shows a better balance when the score is higher.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Assessed before the first intervention (baseline).

Falls Efficacy Scale-International (FES-I)

From 16 to 64. Higher scores show more concern of falling.

Time frame: 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.

Central Contacts

Belén Quel Tejón

CONTACT

675760137 bequelte@gmail.com

José María Blasco Igual

CONTACT

963983855 Jose.Maria.Blasco@uv.es

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Time frame: 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).

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

Assessed with and impedance scale.

Time frame: Assessed before the first intervention (baseline).

Muscle mass

Assessed with and impedance scale.

Time frame: Assessed after the first intervention (3 months later).

Muscle mass

Assessed with and impedance scale.

Time frame: Assessed after the second intervention (3 months after the previous assessement).

Muscle mass

Assessed with and impedance scale.

Time frame: Assessed after 3 months from the previous assessement.