The effect of physical activity interventions on the course of systemic sclerosis

ISRCTN ISRCTN12877295
DOI https://doi.org/10.1186/ISRCTN12877295
Submission date
04/05/2020
Registration date
22/05/2020
Last edited
22/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Systemic sclerosis is characterized by stiffness and contraction of tissues such as the skin, caused by the dominant pathologic feature called fibrosis, which leads to decreased tissue function and to a limitation in the execution of daily activities. The aim the our study was to investigate the impact of a specialized physiotherapy/occupational therapy program focused on the function of the hands and face and quality of life.

Who can participate?
Adults over 18 years, with systemic sclerosis and skin involvement at least of the fingers/hands and the face.

What does the study involve?
Participants will be randomly allocated to receive either treatment as usual or an additional six month program twice a week consisting of supervised physiotherapy (1 hour) and occupational therapy (0.5 hour) focused on the function of hands and face.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Institute of Rheumatology (Czech Republic)

When is the study starting and how long is it expected to run for?
January 2015 to June 2017

Who is funding the study?
Ministry of Health Czech Republic

Who is the main contact?
Dr Michal Tomcik, tomcik@revma.cz

Contact information

Dr Michal Tomcik
Scientific

Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic

ORCiD logoORCID ID 0000-0002-8616-7850
Phone +420 (0)234075101
Email tomcik@revma.cz

Study information

Study designinterventional single-centre prospective non-randomized controlled study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffectiveness of specialized hand/face physical-occupational therapy in patients with systemic sclerosis
Study acronymRHB-SSc
Study objectivesOur specialized, long-term, tailored, physiotherapy/occupational therapy program focused on hand and face involvement in systemic sclerosis patients improves the function of hands/face, disability, quality of life (compared to controls treated with the standard of care).
Ethics approval(s)Approved 29/07/2014, Ethics Committee of the Institute of Rheumatology Prague (Ethics Committee of Institute of Rheumatology Prague, Na Slupi 4, 128 50 Praha 2, Czech Republic; +420 234075244; putova@revma.cz), ref: 1446/2014
Health condition(s) or problem(s) studiedSystemic sclerosis/scleroderma
InterventionControl group: standard of care (i.e. standard pharmacological treatment according to the EULAR/ACR recommendations on the management of systemic sclerosis, education, and materials for regular daily home exercise)
Intervention group: standard of care (as described above) + 6 months of specialized intervention program twice a week consisting of supervised physiotherapy (1 hour) and occupational therapy (0.5 hour) focused on the function of hands and face
Intervention typeBehavioural
Primary outcome measureMeasured at baseline, week 12, week 24, week 48:
1. Function of the hands assessed by:
- HAMIS test (Hand Mobility in Scleroderma)
- delta finger to palm distance
- hand grip strength measured by dynamometry
- CHFS questionnaire (Cochin Hand Function Scale)
2. Function of the face:
- inter-lip and inter-incisor distance
- MHISS questionnaire (Mouth Handicap in Systemic Sclerosis)
Secondary outcome measuresMeasured at baseline, week 12, week 24, week 48:
1. Assessment of health/disability:
- HAQ questionnaire (Health Assessment Questionnaire)
- SHAQ questionnaire (Scleroderma Health Assessment Questionnaire)
2. Quality of life:
- SF-36 questionnaire (Medical Outcomes Short Form-36)
Overall study start date01/05/2014
Completion date30/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants25 patients in the intervention group and 25 patients in the control group
Total final enrolment59
Key inclusion criteria1. Informed consent form signed and dated
2. Reliable and capable of adhering to the protocol and visit schedule
3. At least 18 years of age
4. Fulfilled the 2013 EULAR/ACR classification criteria for systemic sclerosis
5. Skin involvement at least of the fingers/hands and the face
6. Regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist
7. Willing to participate in the study and undergo all planned examinations
Key exclusion criteriaSubject has any other condition, including medical or psychiatric, which in the investigator's judgment would make the subject unsuitable for inclusion in the study
Date of first enrolment01/01/2015
Date of final enrolment01/04/2016

Locations

Countries of recruitment

  • Czech Republic

Study participating centre

Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic

Sponsor information

Revmatologický ústav
Hospital/treatment centre

(Institute of Rheumatology)
Na Slupi 4
Prague
12850
Czech Republic

Phone +420 (0)234075244
Email pavelka@revma.cz
Website http://www.revma.cz/en
ROR logo "ROR" https://ror.org/00jk0vn85

Funders

Funder type

Government

Ministry of Health Czech Republic grant nr. 16-33574A

No information available

Project for Conceptual Development for the institution of Ministry of Health Czech Republic—Institute of Rheumatology (number 023728)

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanning to publish the results in a rheumatology-oriented peer-reviewed journal with impact factor.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Editorial Notes

05/05/2020: Trial’s existence confirmed by Ethics Committee of the Institute of Rheumatology Prague.