The effect of a specialized physiotherapy program in female patients with systemic sclerosis and inflammatory muscle disorders

Not Applicable

Completed

• Conditions: Systemic sclerosis/scleroderma, idiopathic inflammatory myopathies/myositis; Musculoskeletal Diseases; Systemic sclerosis, Myositis

• Registration Number: ISRCTN91200867
• Lead Sponsor: Revmatologický Ústav

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37221419/ results (added 24/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Study Completion: 2021-08-17
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

1. An Independent Ethics Committee approved written Informed Consent form is signed and dated by the subject
2. Subject is considered reliable and capable of adhering to the protocol and visit schedule
3. Subject is female at least 18 years of age
4. Subject fulfilled the 2013 EULAR/ACR classification criteria for systemic sclerosis or Bohan/Peter 1975 criteria for polymyositis/dermatomyositis
6. Subject is regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist
7. Subject is willing to participate in the study and undergo all planned examinations
8. Subject reported low sexual function at least in two of three questionnaires assessing sexual function: Female Sexual Function Index (FSFI), Brief Index of Sexual Functioning for Women (BISF-W), Sexual Function Questionnaire (SFQ-28). Low sexual function in FSFI and SFQ-28 was established based on diagnostic cut-off scores, and in BISF-W, sexual dysfunction was determined based on the 15th percentile obtained from a comparison of healthy control scores of the same age

Exclusion Criteria

1. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured at baseline and week 8:<br> 1. Sexual function assessed with the Female Sexual Function Index questionnaire (FSFI) and the Brief Index of Sexual Functioning for Women questionnaire (BISF-W)<br> 2. Quality of sexual life assessed by Sexual Quality of Life – Female questionnaire (SQoL-F)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured at baseline and week 8:<br> 1. Health/disability assessed by Health Assessment Questionnaire questionnaire (HAQ)<br> 2. Quality of life assessed by Medical Outcomes Short Form-36 questionnaire (SF-36)<br> 3. Depression assessed by Beck's Depression Inventory-II questionnaire (BDI II)<br>