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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Specific Phobia
Fear of Falling

Treatments

Other: Home assessment and modification
Behavioral: Cognitive behavioral therapy
Other: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT02554838
2015-A00400-49 (Other Identifier)
K140702

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

Rehabilitation
Active Comparator group
Description:
Rehabilitation : * Physical activity * Home assessment and modification
Treatment:
Other: Physical activity
Other: Home assessment and modification
Rehabilitation and CBT
Experimental group
Description:
Rehabilitation associated with cognitive behavioral therapy (CBT) : * Physical activity * Home assessment and modification * Cognitive behavioral therapy
Treatment:
Other: Physical activity
Behavioral: Cognitive behavioral therapy
Other: Home assessment and modification

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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