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

Not Applicable

• Conditions: Fear of Falling

• Registration Number: NCT03211429
• Lead Sponsor: Universidad de Caldas

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-01-16
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidad de caldas; 🇨🇴 Manizales, Caldas, Colombia