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

NCT ID: NCT03211429

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Fear of Falling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

No Masking

Study Groups

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Cognitive behavioural therapy

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.

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy

Intervention Type BEHAVIORAL

The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity

Tai chi

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.

Group Type ACTIVE_COMPARATOR

Tai chi

Intervention Type OTHER

Tai Chi training in the Yang style of 24 movement

Postural control exercise

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.

Group Type ACTIVE_COMPARATOR

Postural control exercise

Intervention Type OTHER

Individually adjusted progressive and specific postural control training,

Interventions

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Cognitive behavioural therapy

The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity

Intervention Type BEHAVIORAL

Tai chi

Tai Chi training in the Yang style of 24 movement

Intervention Type OTHER

Postural control exercise

Individually adjusted progressive and specific postural control training,

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Manizales

UNKNOWN

Sponsor Role collaborator

Universidad de Caldas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen L Curcio

Role: PRINCIPAL_INVESTIGATOR

Universidad de Caldas

Locations

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Universidad de caldas

Manizales, Caldas Department, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Carmen L Curcio, PhD

Role: CONTACT

573184665019

Elizabeth Ponce, Psychologist

Role: CONTACT

573008789553

Facility Contacts

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CARMEN L CURCIO, PhD

Role: primary

573184665019

Elizabeth PONCE, Psychologist

Role: backup

573008789553

References

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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.

Reference Type DERIVED
PMID: 30482460 (View on PubMed)

Other Identifiers

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1386316

Identifier Type: -

Identifier Source: org_study_id

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