Effectiveness of Three Interventions to Reduce Fear of Falling and Improve Functionality in the Elderly - Full Text View

Purpose

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.

Condition	Intervention
Fear of Falling	Behavioral: Cognitive behavioural therapy Other: Tai chi Other: Postural control exercise


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Masking Description: No Masking Primary Purpose: Other
Official Title:	Randomized Clinical Trial Evaluating the Effectiveness of Three Interventions Programs to Improve Functionality and Decrease Fear of Falling in the Elderly

Resource links provided by NLM:

MedlinePlus related topics: Falls

U.S. FDA Resources

Further study details as provided by Universidad de Caldas:

Primary Outcome Measures:

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 Outcome Measures:

Falls [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Estimated Enrollment:	110
Study Start Date:	June 2016
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Behavioral: Cognitive behavioural therapy The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity
Active Comparator: 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.	Other: Tai chi Tai Chi training in the Yang style of 24 movement
Active Comparator: 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.	Other: Postural control exercise Individually adjusted progressive and specific postural control training,

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.

Eligibility


Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211429

Contacts


Contact: Carmen L Curcio, PhD	573184665019	carmen.curcio@ucaldas.edu.co
Contact: Elizabeth Ponce, Psychologist	573008789553	ponce@umanizales.edu.co

Locations


Colombia
Universidad de caldas	Recruiting
Manizales, Caldas, Colombia, 170004
Contact: CARMEN L CURCIO, PhD 573184665019 carmen.curcio@ucaldas.edu.co
Contact: Elizabeth PONCE, Psychologist 573008789553 ponce@umanizales.edu.co

Sponsors and Collaborators

Universidad de Caldas

Universidad de Manizales

Investigators


Principal Investigator:	Carmen L Curcio	Universidad de Caldas

More Information


Responsible Party:	Universidad de Caldas
ClinicalTrials.gov Identifier:	NCT03211429 History of Changes
Other Study ID Numbers:	1386316
Study First Received:	January 16, 2017
Last Updated:	July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Data will be available after publication of results. Data will be shared to interested researchers who are planning to perform a meta-analysis. They should write an email to the main contact explaining what type of analysis they will perform and what data they require from the study. Only those data that are considered relevant for the analysis will be shared. Researchers who receive the data should be committed to safeguarding them and complying with and protecting copyright

ClinicalTrials.gov processed this record on July 11, 2017