Specific PhobiaPACTENCT02554838
How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
A study testing Physical activity, Home assessment and modification and Cognitive behavioral therapy in people with Specific Phobia and Fear of Falling, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This project aims to determine the respective impacts of two routine care regarding phobic of falling seniors on the mobility restriction. The investigators used a monocentric, randomized and controlled research according to two parallel groups : physical activity, home assessment and modification (rehabilitation… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Specific Phobia, Fear of Falling
- What is being tested?
- Physical activity, Home assessment and modification and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2019
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years of age or older
- to have a phobia of the fall (according to diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) of specific phobia)
Who cannot join
- Living in a nursing home
- Depression (Mini-Geriatric Depression scale score equal 1 or above)
- Cognitive impairment
- Medical conditions that would be incompatible or limit compliance with the study requirements
- Unable to walk even with assistance
- Patient in a period of exclusion relative to a biomedical study
- Patient's refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to determine the respective impacts of two routine care regarding phobic of falling seniors on the mobility restriction. The investigators used a monocentric, randomized and controlled research according to two parallel groups : physical activity, home assessment and modification (rehabilitation group) versus physical activity, home assessment and modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The investigators will assess the efficacy of usual care (rehabilitation group) and the supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.
Read the detailed description
The fear of falling affects about 20% of seniors living at home, having fallen beforehand or not. Its repercussions, like the premature decline of physical capacities, the decrease in quality of life, the loss of independence and the independent risk of falling are well known. They appear mediated by a restriction of mobility when the phobias of falling take place. Indeed, when a phobia of falling occurs, the person limits her moving to avoid the situations confronting her to the object of her fear - in this case, the fall. However, individuals going outdoors less frequently or moving through smaller life-space areas likely have poorer health and function, and coexisting lower levels of physical activity. Thus increasing life-space area may provide important health benefits in elderly people phobic of the fall.
The usual cares of the phobia of falling are physical activity, home assessment and modification with or without CBT programs. Their efficacy on the increase in mobility has not been properly assessed. One of the priorities is to assess these programs with some tools reporting improvement in mobility and independence.
The Life-Space Assessment (LSA) questionnaire of the Alabama and Birmingham Study of Aging can measure the evolution of the life-space area in an appropriate way, i.e. the spatial area in which a person commonly acts. This 20-item assessment captures the life-space mobility of individuals in five successive areas or life-space (LS) levels (from within the home to outside of town). Subjects are asked the frequency with which they moved in each of the five areas over the past four weeks, and if any assistance (from other persons or with equipment) or no assistance was required. A composite life space score (LSC, range: 0-120) is calculated combining information on the life space level, the degree of independence, and the frequency. Higher scores indicate greater life space. The reliability and construct/criterion validity of this questionnaire translated into French has been published.
The purpose of this study is to compare the effectiveness on an aera of mobility, measured using LSC on three months program combinating physical activity, home assessment and modification (rehabilitation group), versus a program combinating physical activity, home assessment and modification, and CBT (rehabilitation and CBT group) of the senior older than 70, suffering from phobia of falling and living at home.
After the initial study assessment, each participant will benefit during 8 consecutive weeks of a weekly individual session of physical activity, 2 home-based sessions of modification of the home environment and, moreover, for the patients of the rehabilitation and CBT group, a weekly session of individual CBT during the 8 consecutive weeks of the program and a booster session one month later.
Participation in this study will last up to 8 months. LSC will be tested in both groups before, immediately after, 3 and 6 months after completion of the intervention period to explore the benefit of each intervention.
- Conditions
- Specific Phobia, Fear of Falling
- Being tested
- Physical activity, Home assessment and modification, Cognitive behavioral therapy
- Keywords
- Specific phobia, Fear of Falling, Life-space area
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Rehabilitation
Participants receive a weekly individual session of physical activity during 8 consecutive weeks conducted by a licensed physical therapist and focusing on muscle strengthening, flexibility, gait and balance retraining.
Home assessment and modificationOther
Also called Home Care Services
Two home-based sessions of modification of the home environment by a licensed rehabilitation therapist, in order to increase the aera of mobility, the frequency of moving in this aera and the independence to move.
Cognitive behavioral therapyBehavioural
Also called Specific phobia, Fear of Falling, Life-space area
Participants receive during 8 consecutive weeks a weekly individual sessions of CBT and a booster session one month later conducted by a psychologist specialized in CBT focusing on : functional analysis, education about treatment and anxiety, relaxation training and progressive exposure in imagination then in vivo.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Active comparator | Rehabilitation :
* Physical activity
* Home assessment and modification Receives: Other: Physical activity; Other: Home assessment and modification |
| Rehabilitation and CBT | Experimental | Rehabilitation associated with cognitive behavioral therapy (CBT) :
* Physical activity
* Home assessment and modification
* Cognitive behavioral therapy Receives: Other: Physical activity; Other: Home assessment and modification; Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 5 months.
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.
Measured: Baseline, 5 months (3 month follow-up)
Secondary outcomes (7)
Change from baseline in Life-space frequency (a composite score of the Life-Space Assessment which reflects the distance and frequency of movement during the 4 weeks preceding the assessment) at 2, 5 and 8 months.
The life-space frequency ranging from 0 to 60 was calculated based on life-space level score * frequency score at respective level, and then summed, with higher score representing greater mobility.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Change from baseline in Assisted life-space (a score of the Life-Space Assessment which indicating the highest level of life-space attained using the help of assistive devices if needed but not the help of another person) at 2, 5 and 8 months.
The assisted life-space ranging from 0 to 5 was calculated based on life-space level score attained using the help of assistive devices if needed but not the help of another person.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 2, 5, 8 months.
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Number of falls and injurious falls
Falls were defined as "unintentionally coming to rest on the ground, floor, or other lower level" and collected by face-to-face interview of subjects.
Fall events were classified as resulting in "serious" injury if the fall resulted in a fracture, head injuries requiring hospitalisation, joint dislocation, serious sprain, other serious joint injuries, admission to hospital or if any wounds needed stitches (sutures), "moderate" injury if bruising, not serious sprains, cuts, abrasions, or reduction in physical function for at least three days resulted or if the participant sought medical help, and "no" injury.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Fear of falling
Fear of Falling will be measured using the Falls Efficacy Scale-International (FES-I) , a self-report questionnaire of 16 items measuring level of concern about falling during 16 activities of daily living. Minimum score 16, maximum score 64.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Use of anxiolytics drugs in phobic situations related to the phobia of falling
Any change in use of anxiolytics (N05B according to the Anatomical Therapeutic Chemical classification) by participants in phobic situations related to the phobia of falling will be recorded by face-to-face interview.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Self- perceived health
The self-perceived health (SPH) indicator of the Minimum European Health Module is a global measure that encompasses different dimensions of health, i.e. physical, social and emotional function and biomedical signs and symptoms. Self-perceived health appears to be an effective summary of health and has been shown to be a strong predictor of future functional limitations and mortality.
Measured: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion15 May 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine DELPIERRE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554838
- Sponsor's protocol ID
- K140702
- Other IDs
- 2015-A00400-49
- Acronym
- PACTE
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2015
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
- ClinicalTrials.gov ID
- NCT02554838
- Acronym / sponsor ID
- PACTE / K140702
- Conditions
- Specific Phobia, Fear of Falling
- Keywords
- Specific phobia, Fear of Falling, Life-space area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
This project aims to determine the respective impacts of two routine care regarding phobic of falling seniors on the mobility restriction. The investigators used a monocentric, randomized and controlled research according to two parallel groups : physical activity, home assessment and modification (rehabilitation group) versus physical activity, home assessment and modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The investigators will assess the efficacy of usual care (rehabilitation group) and the supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.
Detailed description
The fear of falling affects about 20% of seniors living at home, having fallen beforehand or not. Its repercussions, like the premature decline of physical capacities, the decrease in quality of life, the loss of independence and the independent risk of falling are well known. They appear mediated by a restriction of mobility when the phobias of falling take place. Indeed, when a phobia of falling occurs, the person limits her moving to avoid the situations confronting her to the object of her fear - in this case, the fall. However, individuals going outdoors less frequently or moving through smaller life-space areas likely have poorer health and function, and coexisting lower levels of physical activity. Thus increasing life-space area may provide important health benefits in elderly people phobic of the fall.
The usual cares of the phobia of falling are physical activity, home assessment and modification with or without CBT programs. Their efficacy on the increase in mobility has not been properly assessed. One of the priorities is to assess these programs with some tools reporting improvement in mobility and independence.
The Life-Space Assessment (LSA) questionnaire of the Alabama and Birmingham Study of Aging can measure the evolution of the life-space area in an appropriate way, i.e. the spatial area in which a person commonly acts. This 20-item assessment captures the life-space mobility of individuals in five successive areas or life-space (LS) levels (from within the home to outside of town). Subjects are asked the frequency with which they moved in each of the five areas over the past four weeks, and if any assistance (from other persons or with equipment) or no assistance was required. A composite life space score (LSC, range: 0-120) is calculated combining information on the life space level, the degree of independence, and the frequency. Higher scores indicate greater life space. The reliability and construct/criterion validity of this questionnaire translated into French has been published.
The purpose of this study is to compare the effectiveness on an aera of mobility, measured using LSC on three months program combinating physical activity, home assessment and modification (rehabilitation group), versus a program combinating physical activity, home assessment and modification, and CBT (rehabilitation and CBT group) of the senior older than 70, suffering from phobia of falling and living at home.
After the initial study assessment, each participant will benefit during 8 consecutive weeks of a weekly individual session of physical activity, 2 home-based sessions of modification of the home environment and, moreover, for the patients of the rehabilitation and CBT group, a weekly session of individual CBT during the 8 consecutive weeks of the program and a booster session one month later.
Participation in this study will last up to 8 months. LSC will be tested in both groups before, immediately after, 3 and 6 months after completion of the intervention period to explore the benefit of each intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Active comparator | Other: Physical activity, Other: Home assessment and modificationRehabilitation : * Physical activity * Home assessment and modification |
| Rehabilitation and CBT | Experimental | Other: Physical activity, Other: Home assessment and modification, Behavioral: Cognitive behavioral therapyRehabilitation associated with cognitive behavioral therapy (CBT) : * Physical activity * Home assessment and modification * Cognitive behavioral therapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 70 years of age or older
- to have a phobia of the fall (according to diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) of specific phobia)
Key exclusion criteria (7 listed)
- Living in a nursing home
- Depression (Mini-Geriatric Depression scale score equal 1 or above)
- Cognitive impairment
- Medical conditions that would be incompatible or limit compliance with the study requirements
- Unable to walk even with assistance
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 |
|---|---|---|
| Physical activityAlso: RehabilitationParticipants receive a weekly individual session of physical activity during 8 consecutive weeks conducted by a licensed physical therapist and focusing on muscle strengthening, flexibility, gait and balance retraining. | Other | Rehabilitation, Rehabilitation and CBT |
| Home assessment and modificationAlso: Home Care ServicesTwo home-based sessions of modification of the home environment by a licensed rehabilitation therapist, in order to increase the aera of mobility, the frequency of moving in this aera and the independence to move. | Other | Rehabilitation, Rehabilitation and CBT |
| Cognitive behavioral therapyAlso: Specific phobia, Fear of Falling, Life-space areaParticipants receive during 8 consecutive weeks a weekly individual sessions of CBT and a booster session one month later conducted by a psychologist specialized in CBT focusing on : functional analysis, education about treatment and anxiety, relaxation training and progressive exposure in imagination then in vivo. | Behavioural | Rehabilitation and CBT |
Primary outcome
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 5 months.
Time frame: Baseline, 5 months (3 month follow-up)
For each life-space level (bedroom (score 0), other rooms (1), outside home (2), neighborhood (3), town (4), beyond town (5)), participants were asked how many days a week they attained that level (frequency; <1×/week (score 1), 1-3x/week (2), 4-6x/week (3), daily (4)) and whether they needed help from another person or from assistive devices (assistance; no assistance (score 2), equipment only (1½), personal assistance needed (1)). The LSC ranging from 0 to 120 was calculated based on life-space level *degree of independence in achieving each level * frequency of attaining each level, and then summed for all levels, with higher score representing greater mobility.
7 secondary outcomes
Change from baseline in Life-space frequency (a composite score of the Life-Space Assessment which reflects the distance and frequency of movement during the 4 weeks preceding the assessment) at 2, 5 and 8 months.
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Change from baseline in Assisted life-space (a score of the Life-Space Assessment which indicating the highest level of life-space attained using the help of assistive devices if needed but not the help of another person) at 2, 5 and 8 months.
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 2, 5, 8 months.
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Number of falls and injurious falls
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Fear of falling
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Use of anxiolytics drugs in phobic situations related to the phobia of falling
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Self- perceived health
Time frame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Sandrine DELPIERRE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity, Home assessment and modification and Cognitive behavioral therapy in people with Specific Phobia and Fear of Falling, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 16 Feb 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Life-space mobility assessed by the LSC (a composite score of the Life-Space Assessment which reflects the distance, frequency and level of independence of movement during the 4 weeks preceding the assessment) at 5 months. (time frame: Baseline, 5 months (3 month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.