Clinical trial NCT00318188: Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis
Official title: Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Scleroderma
Keywords: scleroderma
HAQ
Intensive care reeducation, readaptation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.


Eligibility criteria: Inclusion Criteria:

* Men or women aged from 18 years or more, with diagnostic of SSc considering the ACR and/or Leroy and Medsger's criteria.
* HAQ greater than or equal to 0.5
* A perception of limitation of mouth opening and/or at least one limitation in range of motion due to illness
* Good understanding of the French language

Exclusion Criteria :

* Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
* Any underlying disease that may be incompatible with the management, discovery at the inclusion visit
* Cognitive problems making it impossible to assess the primary outcome measure
* Patients with a standardized rehabilitation program within 6 months prior to inclusion
* Impairment of comprehension or expression of the French language
* Patients participating in another clinical trial or participated in another clinical trial in the previous 3 months.

Primary outcomes:
measure: HAQ DI:Health Assessment questionnaire disability index
timeFrame: at 12 months
Secondary outcomes:
measure: Mac Tar (Mc Master Toronto Arthritis questionnaire)
timeFrame: at 12 months
measure: S-HAQ ( scleroderma-modified health assessment questionnaire)
timeFrame: at 12 months
measure: SF 36
timeFrame: at 12 months
measure: Kapandji modified index
timeFrame: at 12 months
measure: Rodnan score
timeFrame: at 12 months
measure: Hand Cochin Function Scale
timeFrame: at 12 months
measure: Pain
timeFrame: at 12 months
measure: Mouth opening
timeFrame: at 12 months
measure: Forced expiratory volume (FEV)
timeFrame: at 12 months
measure: Satisfaction of clinical condition
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Reeducation and readaptation Department
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Serge POIRAUDEAU, MD-PhD
role: STUDY_CHAIR
References:
citation: Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.
citation: Daste C, Rannou F, Mouthon L, Sanchez K, Roren A, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Poiraudeau S, Nguyen C. Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care. Semin Arthritis Rheum. 2019 Feb;48(4):694-700. doi: 10.1016/j.semarthrit.2018.03.013. Epub 2018 Mar 27.