Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study (OPTICHUTE)

Fondation Hôpital Saint-Joseph

Status: Active, not recruiting

Conditions: Osteoporotic Fractures

Treatments: Other: rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT03642808

OPTICHUTE

Details and patient eligibility

About

Within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), a reinforced medical care of osteoporosis ('Fracture Liaison service') was organized for osteoporotic fractured patients. The evaluation of benefits of this program through a randomized study showed an improvement in diagnostic tests performed (bone densitometry) and antiosteoporotic treatment initiated (OPTIPOST study, being published in BMJ). However, of 323 patients included, 91 presented a new fracture within 12 months. Among them, 40/126 patients (31.7%) were in the reinforced medical care arm. This result clearly demonstrates the need for a specific medical care program for patients with osteoporotic fracture falling regularly.

Full description

Only few studies for secondary prevention of falls have been conducted in France yet. This can be partly explained by the complexity of reeducation programs to implement and by organization issues. Moreover, to our knowledge, no study has demonstrated the benefit of such programs on secondary prevention of osteoporotic fractures, even though falls prevention is needed. Our objective is to demonstrate with a pilot study the feasibility of a falls secondary prevention program, based on a rheumatology (GHPSJ) and reeducation wards (Hôpital Sainte-Marie Paris : HSMP) collaboration. Considering the innovative nature of both this program and this collaboration, a feasibility study is preferable before conducting a larger multicentric study, evaluating locomoter benefits of this program in comparison with usual primary care.

Enrollment: 17 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women (age ≥ 60 years)
• Francophone
• Hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in Groupe Hospitalier Paris Saint-Joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months
• Patient with an acceptable handicap level definied by a Timed Up & Go test (TUG) <14 seconds
• Autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and Activities of Daily Living score (6 items) ≥5.5/6
• Patient with medical insurance

Exclusion criteria

• History of locomor specialized care for the falls prevention
• Cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program
• Fall due to a neurovascular disease or acute cardiovascular
• Significant comorbidities which don't permit a locomotor rehabilitation care
• Refusal to participate in the study
• Refusal to follow the entire rehabilitation program
• Geographic remoteness which doesn't permit the movement to the rehabilitation center
• Contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease
• Patient under guardianship or curatorship
• Patient deprived of liberty

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

rehabilitation program

Experimental group

Description:

* Duration of 8 weeks for a cycle of rehabilitation at the rate of two half-days per week * Two interventions per half-day: 30 minutes of education and 1h30 of rehabilitation: physiotherapist, psychomotricity, adapted physical activity

Treatment:

Other: rehabilitation program