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

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ClinicalTrials.gov Identifier: NCT03211429
Recruitment Status : Unknown
Verified July 2017 by Universidad de Caldas.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
Universidad de Manizales
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fear of Falling Behavioral: Cognitive behavioural therapy Other: Tai chi Other: Postural control exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : June 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
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,




Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211429


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

Locations
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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
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Principal Investigator: Carmen L Curcio Universidad de Caldas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad de Caldas
ClinicalTrials.gov Identifier: NCT03211429    
Other Study ID Numbers: 1386316
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 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