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Clinical Trials/NCT03211429
NCT03211429
Unknown
Not Applicable

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

Universidad de Caldas1 site in 1 country110 target enrollmentJune 2016
ConditionsFear of Falling

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fear of Falling
Sponsor
Universidad de Caldas
Enrollment
110
Locations
1
Primary Endpoint
Fear of falling
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad de Caldas
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Community-dwelling older people
  • People who reported fear of falling
  • "Leganés Cognitive Test" ≥23

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

Outcomes

Primary Outcomes

Fear of falling

Time Frame: Prospective change from baseline to end of intervention (8 weeks)

Fear of falling is evaluated using Falls Efficacy Scale International questionnaire

Functional mobility

Time Frame: Prospective change from baseline to end of intervention (8 weeks)

Functional mobility is evaluated using gait speed and Short Physical performance Battery (SPPB).

Secondary Outcomes

  • Falls(Prospective change from baseline to end of intervention (8 weeks))
  • Depression(Prospective change from baseline to end of intervention (8 weeks))
  • Handgrip(Prospective change from baseline to end of intervention (8 weeks))
  • Daily life activities(Prospective change from baseline to end of intervention (8 weeks))
  • Self-Rated Health(Prospective change from baseline to end of intervention (8 weeks))
  • Postural control(Prospective change from baseline to end of intervention (8 weeks))

Study Sites (1)

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