Effectiveness of Three Interventions to Reduce Fear of Falling and Improve Functionality in the Elderly

Study Overview
=================
Brief Summary
-----------------
Fear of falling is a major health problem among community-dwelling older adults that may contribute to avoidance of activities that they are capable of performing. Studies show that the fear of falling may lead to a continual, complex decline in older adults that includes a loss of auto efficacy, restriction of physical activities and social participation, physical frailty, falls and disability. Apart from these effects, the fear of falling may also have financial implications for health care systems and the general public. Several interventions have been shown to reduce fear of falling with multifactorial interventions, including physical and behavioral components, being most successful. Behavioral components usually comprise strategies to reduce catastrophic thinking and fear-related avoidance behaviors while physical components usually comprise falls prevention exercise programs. However, multifactorial programs are not always feasible or preferred by older people. In this framework, the objective of this works is to assess the effects (benefits and effectiveness) of three interventions programs (Tai Chi, postural control exercises and behavioral therapy intervention) to improve functionality and decrease fear of falling in older people living in the community.

Detailed Description
-----------------
Fear of falling is common among elderly people. Fear of falling can be associated with reductions in physical and social activities and negative impacts on quality of life. Several interventions have been shown to reduce the fear of falling, but their effectiveness has not been compared. The objective of this study is to evaluate the effectiveness of three interventions programs to improve functionality and decrease fear of falling in the Elderly. Effective interventions to lessen fear of falling could therefore have significant consequences for individuals, their families and healthcare delivery systems. Methods/Design: This is a controlled, randomized clinical trial of individual assignment, carried out on community living elderly, from Manizales (Colombia) who reporting fear of falling with restriction of activities of daily living.

Official Title
-----------------
Randomized Clinical Trial Evaluating the Effectiveness of Three Interventions Programs to Improve Functionality and Decrease Fear of Falling in the Elderly

Conditions
-----------------
Fear of Falling

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioural therapy
* Other: Tai chi
* Other: Postural control exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community-dwelling older people People who reported fear of falling Leganés Cognitive Test ≥23 SPPB ≤ 9 Exclusion Criteria: Some cognitive affection and/or medical condition that may affect the intervention Permanent use of wheelchair People who have received prior protocolized management for fear of falling

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive behavioural therapy<br>The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity, in order to increase their physical, social and functional activities. The cognitive behavioural intervention program, provides by psychologists, consists of eight group sessions, 60 minutes each. During each session a main theme is addressed. The themes of the program are: concerns about falls; thoughts about falling; physical exercise; asserting oneself; overcoming personal barriers; safe behaviour; and managing concerns about falls. | Behavioral: Cognitive behavioural therapy<br>* The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity<br>|
| Active Comparator: Tai chi<br>Subjects in the Tai Chi group undertook supervised Tai Chi training in the Yang style of 24 movements, for one hour, once a week for 8 weeks. The first 5 min was allocated for warm-up, with the rest of the time for Tai Chi practice. | Other: Tai chi<br>* Tai Chi training in the Yang style of 24 movement<br>|
| Active Comparator: Postural control exercise<br>Individually adjusted progressive and specific postural control training, provided by physiotherapists for one hour, one time per week for 8 weeks. The exercise is progressive and specific to functional postural control tasks. It comprises elements that represent activities included in, and required for, independent daily living, such as maintaining balance when sitting, standing and walking; and also reacting to loss of balance. | Other: Postural control exercise<br>* Individually adjusted progressive and specific postural control training,<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of falling | Fear of falling is evaluated using Falls Efficacy Scale International questionnaire | Prospective change from baseline to end of intervention (8 weeks) | 
| Functional mobility | Functional mobility is evaluated using gait speed and Short Physical performance Battery (SPPB). | Prospective change from baseline to end of intervention (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Number of falls in the last year evaluated by open question to the participant | Prospective change from baseline to end of intervention (8 weeks) | 
| Depression | Prospective change from baseline to end of intervention (8 weeks) as measured by the scale of Yesavage | Prospective change from baseline to end of intervention (8 weeks) | 
| Handgrip | Prospective change from baseline to end of intervention (8 weeks) Measured through the dynamometer | Prospective change from baseline to end of intervention (8 weeks) | 
| Daily life activities | Daily life activities at the instrumental level measured through the Lawton and Brody scale | Prospective change from baseline to end of intervention (8 weeks) | 
| Self-Rated Health | Subjective assessment of health status by simple dichotomous scale and ordinal scale (Likert scale) with 5 options | Prospective change from baseline to end of intervention (8 weeks) | 
| Postural control | under reduced or conflicting sensory conditions and fall risk were investigated, using the Biodex Balance System | Prospective change from baseline to end of intervention (8 weeks) |