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

NCT02554838 | Completed

• 2 other identifiers: K1407022015-A00400-49
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Specific Phobia; Fear of Falling

Keywords

Specific phobia; Fear of Falling; Life-space area

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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

  Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)

• Fear of falling

  Baseline, 2 months (end of intervention), 5 months (3 month follow-up) and 8 months (6 month follow-up)

Study Arms (2)

Rehabilitation

ACTIVE COMPARATOR

Rehabilitation : * Physical activity * Home assessment and modification

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

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

Interventions

Physical activity 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.

Also known as: Rehabilitation

Rehabilitation; Rehabilitation and CBT

Home assessment and modification 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.

Also known as: Home Care Services

Rehabilitation; Rehabilitation and CBT

Cognitive behavioral therapy 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.

Also known as: Specific phobia, Fear of Falling, Life-space area

Rehabilitation and CBT

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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's refusal of participation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bretonneau

Paris, 75018, France

Location

MeSH Terms

Conditions

Phobia, Specific

Interventions

Exercise; Rehabilitation; Home Care Services; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Nursing Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sandrine DELPIERRE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: November 1, 2015
• Primary Completion: May 15, 2019
• Study Completion: November 1, 2019
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

FR (1)