Clinical trial NCT03211429: Effectiveness of Three Interventions to Reduce Fear of Falling and Improve Functionality in the Elderly
Official title: Randomized Clinical Trial Evaluating the Effectiveness of Three Interventions Programs to Improve Functionality and Decrease Fear of Falling in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fear of Falling
Lead sponsor: Universidad de Caldas
Sponsor class: OTHER
Collaborators: name: Universidad de Manizales
First posted: 2017-07-07
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Fear of falling
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Functional mobility
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
Secondary outcomes:
measure: Falls
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Depression
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Handgrip
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Daily life activities
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Self-Rated Health
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
measure: Postural control
timeFrame: Prospective change from baseline to end of intervention (8 weeks)
Other outcomes:
Locations:
city: Manizales
country: Colombia
facility: Universidad de caldas
state: Caldas
Study officials:
affiliation: Universidad de Caldas
name: Carmen L Curcio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duenas EP, Ramirez LP, Ponce E, Curcio CL. [Effect on fear of falling and functionality of three intervention programs. A randomised clinical trial]. Rev Esp Geriatr Gerontol. 2019 Mar-Apr;54(2):68-74. doi: 10.1016/j.regg.2018.09.013. Epub 2018 Nov 24. Spanish.