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
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
Scientific
Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic
 ORCID ID |
0000-0002-8616-7850 |
|---|---|
| Phone | +420 (0)234075101 |
| tomcik@revma.cz |
Study information
| Study design | interventional single-centre prospective non-randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of specialized hand/face physical-occupational therapy in patients with systemic sclerosis |
| Study acronym | RHB-SSc |
| Study objectives | Our 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) studied | Systemic sclerosis/scleroderma |
| Intervention | Control 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 type | Behavioural |
| Primary outcome measure | Measured 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 measures | Measured 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 date | 01/05/2014 |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 patients in the intervention group and 25 patients in the control group |
| Total final enrolment | 59 |
| Key inclusion criteria | 1. 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 criteria | Subject 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 enrolment | 01/01/2015 |
| Date of final enrolment | 01/04/2016 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Prague
12850
Czech Republic
Sponsor information
Hospital/treatment centre
(Institute of Rheumatology)
Na Slupi 4
Prague
12850
Czech Republic
| Phone | +420 (0)234075244 |
|---|---|
| pavelka@revma.cz | |
| Website | http://www.revma.cz/en |
"ROR" |
https://ror.org/00jk0vn85 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planning to publish the results in a rheumatology-oriented peer-reviewed journal with impact factor. |
| IPD sharing plan | The 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.
