Fear of FallingNCT03211429
Effectiveness of Three Interventions to Reduce Fear of Falling and Improve Functionality in the Elderly
A study testing Cognitive behavioural therapy and Tai chi in people with Fear of Falling, run by Universidad de Caldas at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fear of Falling
- What is being tested?
- Cognitive behavioural therapy and Tai chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling older people
- People who reported fear of falling
- "Leganés Cognitive Test" ≥23
- SPPB ≤ 9
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Universidad de caldas
Manizales, Caldas Department, 170004
CARMEN L CURCIO, PhD, 573184665019, carmen.curcio@ucaldas.edu.co
Elizabeth PONCE, Psychologist, 573008789553, ponce@umanizales.edu.co
About this study
Official title: Randomized Clinical Trial Evaluating the Effectiveness of Three Interventions Programs to Improve Functionality and Decrease Fear of Falling in the Elderly
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.
Read the 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.
- Conditions
- Fear of Falling
- Being tested
- Cognitive behavioural therapy, Tai chi, Postural control exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity
Tai chiOther
Tai Chi training in the Yang style of 24 movement
Postural control exerciseOther
Individually adjusted progressive and specific postural control training,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Postural control exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of falling
Fear of falling is evaluated using Falls Efficacy Scale International questionnaire
Measured: 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).
Measured: Prospective change from baseline to end of intervention (8 weeks)
Secondary outcomes (6)
Falls
Number of falls in the last year evaluated by open question to the participant
Measured: Prospective change from baseline to end of intervention (8 weeks)
Depression
Prospective change from baseline to end of intervention (8 weeks) as measured by the scale of Yesavage
Measured: Prospective change from baseline to end of intervention (8 weeks)
Handgrip
Prospective change from baseline to end of intervention (8 weeks) Measured through the dynamometer
Measured: Prospective change from baseline to end of intervention (8 weeks)
Daily life activities
Daily life activities at the instrumental level measured through the Lawton and Brody scale
Measured: Prospective change from baseline to end of intervention (8 weeks)
Self-Rated Health
Subjective assessment of health status by simple dichotomous scale and ordinal scale (Likert scale) with 5 options
Measured: Prospective change from baseline to end of intervention (8 weeks)
Postural control
under reduced or conflicting sensory conditions and fall risk were investigated, using the Biodex Balance System
Measured: Prospective change from baseline to end of intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startJun 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Caldas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Manizales
- Responsible party
- Sponsor
- Investigators
- Carmen L Curcio, Principal investigator, Universidad de Caldas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211429
- Sponsor's protocol ID
- 1386316
- Status last verified
- Jul 2017
- First submitted
- 16 Jan 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 30482460
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating the Effectiveness of Three Interventions Programs to Improve Functionality and Decrease Fear of Falling in the Elderly
- ClinicalTrials.gov ID
- NCT03211429
- Acronym / sponsor ID
- 1386316
- Conditions
- Fear of Falling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidad de CaldasUniversity, hospital or other
- Collaborators
- Universidad de Manizales
- Study start
- Jun 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy | Active comparator | Behavioral: Cognitive behavioural therapyThe 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. |
| Tai chi | Active comparator | Other: Tai chiSubjects 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. |
| Postural control exercise | Active comparator | Other: Postural control exerciseIndividually 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Community-dwelling older people
- People who reported fear of falling
- "Leganés Cognitive Test" ≥23
- SPPB ≤ 9
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapyThe program aims to teach participants how to deal with their concerns about falls and related avoidance of activity | Behavioural | Cognitive behavioural therapy |
| Tai chiTai Chi training in the Yang style of 24 movement | Other | Tai chi |
| Postural control exerciseIndividually adjusted progressive and specific postural control training, | Other | Postural control exercise |
Primary outcome
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).
6 secondary outcomes
Falls
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Depression
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Handgrip
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Daily life activities
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Self-Rated Health
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Postural control
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Derived from this study: PubMed 30482460Duenas 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.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen L Curcio principal investigator
Universidad de Caldas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy and Tai chi in people with Fear of Falling, run by Universidad de Caldas at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen L Curcio, PhD (573184665019, carmen.curcio@ucaldas.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of falling (time frame: Prospective change from baseline to end of intervention (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.