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

NCT03211429 | Unknown

• 1 other identifier: 1386316
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Falling

Outcome Measures

Primary Outcomes (2)

• Fear of falling

  Fear of falling is evaluated using Falls Efficacy Scale International questionnaire

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

• 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 Outcomes (6)

• 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)

Study Arms (3)

Cognitive behavioural therapy

ACTIVE COMPARATOR

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.

Behavioral: Cognitive behavioural therapy

Tai chi

ACTIVE COMPARATOR

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.

Other: Tai chi

Postural control exercise

ACTIVE COMPARATOR

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.

Other: Postural control exercise

Interventions

Cognitive behavioural therapy BEHAVIORAL

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

Cognitive behavioural therapy

Tai chi OTHER

Tai Chi training in the Yang style of 24 movement

Tai chi

Postural control exercise OTHER

Individually adjusted progressive and specific postural control training,

Postural control exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling older people
• People who reported fear of falling
• "Leganés Cognitive Test" ≥23
• SPPB ≤ 9

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Caldas: lead
• Universidad de Manizales: collaborator

Study Sites (1)

Universidad de caldas

Manizales, Caldas Department, 170004, Colombia

RECRUITING

Related Publications (1)

• 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.

  PMID: 30482460 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy; Tai Ji

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Carmen L Curcio

  Universidad de Caldas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen L Curcio, PhD

CONTACT

573184665019; carmen.curcio@ucaldas.edu.co

Elizabeth Ponce, Psychologist

CONTACT

573008789553; ponce@umanizales.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: July 7, 2017
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

CO (1)