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

Fear of Falling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03211429
• Other study ID #: 1386316
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2017
• Last updated: July 5, 2017
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Universidad de Caldas
• Contact: Carmen L Curcio, PhD
• Phone: 573184665019
• Email: carmen.curcio[@]ucaldas.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fear of Falling

Intervention

Behavioral:
• Cognitive behavioural therapy
The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity

Other:
• Tai chi
Tai Chi training in the Yang style of 24 movement
• Postural control exercise
Individually adjusted progressive and specific postural control training,

Locations

Country	Name	City	State
Colombia	Universidad de caldas	Manizales	Caldas

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Caldas	Universidad de Manizales

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of falling	Fear of falling is evaluated using Falls Efficacy Scale International questionnaire	Prospective change from baseline to end of intervention (8 weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)