Frail Elderly Syndrome, Fall
Conditions
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.
Interventions
The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) | Assessed before the first intervention (baseline). | — |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Falls Efficacy Scale-International (FES-I) | Assessed before the first intervention (baseline). | From 16 to 64. Higher scores show more concern of falling. |
| Falls and their consequences | Assessed before the first intervention (baseline). | The number of falls in the last year will be asked. |
| Muscle mass | Assessed before the first intervention (baseline). | Assessed with and impedance scale. |
| 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). |
| Berg Balance Scale (BBS) | Assessed before the first intervention (baseline). | From 0 to 56. It shows a better balance when the score is higher. |
Countries
Spain
Contacts
Primary ContactBelén Quel Tejón
Backup ContactJosé María Blasco Igual
Outcome results
None listed