Clinical trial NCT02554838: How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
Official title: How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Fear of Falling
Keywords: Specific phobia
Fear of Falling
Life-space area
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 47
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: Baseline, 5 months (3 month follow-up)
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
measure: 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.
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
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 2, 5, 8 months.
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
measure: Number of falls and injurious falls
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
measure: Fear of falling
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
measure: Use of anxiolytics drugs in phobic situations related to the phobia of falling
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
measure: Self- perceived health
timeFrame: Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sandrine DELPIERRE, MD
role: PRINCIPAL_INVESTIGATOR
References: