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 Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Frail Elderly Syndrome, Fall

Intervention / Treatment
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* Other: Therapeutic exercise program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br> | Other: Therapeutic exercise program<br>* The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) |  | Assessed before the first intervention (baseline). | 
| Timed Up and Go (TUG) |  | Assessed after the first intervention (3 months later). | 
| Timed Up and Go (TUG) |  | Assessed after the second intervention (3 months after the previous assessement). | 
| Timed Up and Go (TUG) |  | 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. | 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. | 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. | 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. | Assessed after 3 months from the previous assessement. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls and their consequences | The number of falls in the last year will be asked. | Assessed before the first intervention (baseline). | 
| Falls and their consequences | A follow-up made with phone calls. | 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. | Assessed before the first intervention (baseline). | 
| Berg Balance Scale (BBS) | From 0 to 56. It shows a better balance when the score is higher. | 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. | 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. | 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. | Assessed before the first intervention (baseline). | 
| Falls Efficacy Scale-International (FES-I) | From 16 to 64. Higher scores show more concern of falling. | 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. | 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. | 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). | 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). | 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). | 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). | Assessed after 3 months from the previous assessement. | 
| Muscle mass | Assessed with and impedance scale. | Assessed before the first intervention (baseline). | 
| Muscle mass | Assessed with and impedance scale. | Assessed after the first intervention (3 months later). | 
| Muscle mass | Assessed with and impedance scale. | Assessed after the second intervention (3 months after the previous assessement). | 
| Muscle mass | Assessed with and impedance scale. | Assessed after 3 months from the previous assessement. |