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 Details
Study Description
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:
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If the therapeutic exercise program proposed is a successful treatment for this kind of patients
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise group
|
Other: Therapeutic exercise program
The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.
|
| No Intervention: Control group
|
Outcome Measures
Primary Outcome Measures
- 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 [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 [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 [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 [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.
Secondary Outcome Measures
- Falls and their consequences [Assessed before the first intervention (baseline).]
The number of falls in the last year will be asked.
- Falls and their consequences [Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.]
A follow-up made with phone calls.
- Berg Balance Scale (BBS) [Assessed before the first intervention (baseline).]
From 0 to 56. It shows a better balance when the score is higher.
- Berg Balance Scale (BBS) [Assessed after the first intervention (3 months later).]
From 0 to 56. It shows a better balance when the score is higher.
- Berg Balance Scale (BBS) [Assessed after the second intervention (3 months after the previous assessement).]
From 0 to 56. It shows a better balance when the score is higher.
- Berg Balance Scale (BBS) [Assessed after 3 months from the previous assessement.]
From 0 to 56. It shows a better balance when the score is higher.
- Falls Efficacy Scale-International (FES-I) [Assessed before the first intervention (baseline).]
From 16 to 64. Higher scores show more concern of falling.
- Falls Efficacy Scale-International (FES-I) [Assessed after the first intervention (3 months later).]
From 16 to 64. Higher scores show more concern of falling.
- Falls Efficacy Scale-International (FES-I) [Assessed after the second intervention (3 months after the previous assessement).]
From 16 to 64. Higher scores show more concern of falling.
- Falls Efficacy Scale-International (FES-I) [Assessed after 3 months from the previous assessement.]
From 16 to 64. Higher scores show more concern of falling.
- European Quality of Life-5 Dimensions (EuroQol-5D) [Assessed before the first intervention (baseline).]
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).
- European Quality of Life-5 Dimensions (EuroQol-5D) [Assessed after the first intervention (3 months later).]
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).
- European Quality of Life-5 Dimensions (EuroQol-5D) [Assessed after the second intervention (3 months after the previous assessement).]
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).
- European Quality of Life-5 Dimensions (EuroQol-5D) [Assessed after 3 months from the previous assessement.]
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).
- Muscle mass [Assessed before the first intervention (baseline).]
Assessed with and impedance scale.
- Muscle mass [Assessed after the first intervention (3 months later).]
Assessed with and impedance scale.
- Muscle mass [Assessed after the second intervention (3 months after the previous assessement).]
Assessed with and impedance scale.
- Muscle mass [Assessed after 3 months from the previous assessement.]
Assessed with and impedance scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Community dwelling older adults.
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Independent for ambulation.
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With a cognitive state that do not prevent understand the researcher indications.
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Not performing regular physical exercise (only basic activities of daily living, but no other type of intervention).
Exclusion Criteria:
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Contraindication of physical exercise.
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Evident impaired cognitive state.
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Vestibular or central nervous system affection.
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Can´t speak and understand spanish correctly.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Valencia | Valencia | Spain | 46010 |
Sponsors and Collaborators
- University of Valencia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H1504602336419