How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling

NCT ID: NCT02554838

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-11-30

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.

Conditions

Specific Phobia; Fear of Falling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation

Rehabilitation :

• Physical activity
• Home assessment and modification

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: OTHER

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 modification

Intervention Type: OTHER

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.

Rehabilitation and CBT

Rehabilitation associated with cognitive behavioral therapy (CBT) :

• Physical activity
• Home assessment and modification
• Cognitive behavioral therapy

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

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 modification

Intervention Type: OTHER

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 therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Physical activity

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.

Intervention Type: OTHER

Home assessment and modification

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.

Intervention Type: OTHER

Cognitive behavioral therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Rehabilitation; Home Care Services; Specific phobia; Fear of Falling; Life-space area

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandrine DELPIERRE, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bretonneau

Paris, , France

Countries

France

Other Identifiers

2015-A00400-49

Identifier Type: OTHER

Identifier Source: secondary_id

K140702

Identifier Type: -

Identifier Source: org_study_id