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This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in daily activities carried out through group workshops (guided by a physiotherapist) and at preventing risk situations at home.
Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.
The study tries to assess whether a group intervention following the principles of the sLiFE program is more effective than an usual health advice reducing the incidence of falls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The strength and balance activities of the sLiFE program will be carried out. Participants will be invited to participate in groups of about 14 people in Primary Care Heath Centers. |
|
| Control Group | Placebo Comparator | Participants will receive the usual health advice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Behavioral | Subjects will participate in groups of about 14 to implement the program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of falls | Number of falls in relation to the degree of physical activity. | 6 months |
| Physical activity | It will be evaluated with a digital pedometer for 9 consecutive days | 8 days |
| Physical activity | It will be evaluated with the Global Physical Activity Questionnaire | 6 months |
| Frailty | Frailty will be measured according to the five criteria of Fried's phenotype: 1) Low muscle strength; 2) Poor nutrition; 3) Poor endurance; 4) Slow walking and 5) Low physical activity. | 6 months |
| Health effects | It will be measured using the quality of life questionnaire EQ-5D | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fear of falling | It will be assesses using the Short Falls International Scale of Efficacy (Short FES I). It measures of "concerns about falling". This scale has 7 items with a Likert scale with 4 options: 1) not at all concerned, 2) somewhat concerned, 3) fairly concerned, and 4) very concerned. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emiliano RodrÃguez-Sánchez, Dr | Contact | 923231859 | emiliano@usal.es | |
| Luis GarcÃa-Ortiz, Dr | Contact | 635542886 | lgarciao@usal.es |
| Name | Affiliation | Role |
|---|---|---|
| Luis GarcÃa-Ortiz, Dr | Primary Health Care Research Unit | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Research Unit of Salamanca (APISAL) | Recruiting | Salamanca | 37005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38259747 | Derived | Llamas-Ramos I, Llamas-Ramos R, Lugones-Sanchez C, Gonzalez-Garcia S, Tamayo-Morales O, Alvarado-Omenat JJ, Pablos-Hernandez C, Gomez-Marcos MA, Garcia-Ortiz L, Rodriguez-Sanchez E. Effect of a lifestyle-integrated functional exercise (LiFE) group intervention (sLiFE) to falls prevention in non-institutionalized older adults. Protocol of a randomised clinical trial. Front Public Health. 2024 Jan 8;11:1304982. doi: 10.3389/fpubh.2023.1304982. eCollection 2023. |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group | Behavioral | Subjects will receive the usual care advice |
|
| Cognitive assessment |
It will be evaluated with the Montreal Cognitive Assessment (MoCA): 30 questions and takes 10-12 minutes to complete. |
| 6 months |
| Motor function | It will be evaluated with the Short Physical Performance Battery (SPPB). It assesses three aspects of mobility: balance, gait speed and strength of limbs or lower limbs to get up from a chair | 6 months |
| Adherence to exercise | It will be assessed using the Exercise Adherence Rating Scale (EARS). It is composed of 16 items scored using a 5-point Likert scale (0 = completely agree to 4 = completely disagree) with a possible summed score range from 0 to 64. | 6 months |
| D008722 | Methods |