The effect of physical activity interventions on inflammatory muscle disorders

Effectiveness of specialized activities of daily living training in patients with idiopathic inflammatory myopathies

Registry ID
ISRCTN35925199
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Revmatologický ústav
Enrollment
40
Start date
2015-01-01
Completion date
2017-06-30
Last update
2026-08-17

Conditions

Summary

Idiopathic inflammatory myopathies/myositis

Detailed description

Patients are allocated into the intervention or control group based on their willingness to adhere to the schedule. Control group: standard of care (i.e. standard pharmacological treatment according to the recommendations of the leading experts in the field on the management of idiopathic inflammatory myopathies, education, and materials for regular daily home exercise focused on activities of daily living) Intervention group: standard of care (as described above) + 6 months of specialized intervention program twice a week consisting of supervised physiotherapy (1 hour focused on activities of daily living and 1 hour focused on muscle strengthening) Outcomes measured at baseline (i.e. week 0, before the start of the study), week 12 (i.e. after half of the 6-month intervention), week 24 (i.e. after the end of the 6-month intervention), and week 48 (i.e. after the end of a 6-month follow-up)

Interventions

Inclusion criteria

1. An Independent Ethics Committee approved written Informed Consent form is signed and dated by the subject 2. Participant is considered reliable and capable of adhering to the protocol and visit schedule 3. Participant is male or female at least 18 years of age 4. Participant fulfilled the Bohan/Peter 1975 criteria (for polymyositis and dermatomyositis) or the ENMC 2004 criteria (for immune-mediated necrotizing myopathy) 5. Participant must have a weakness of proximal muscle groups 6. Participant is regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist 7. Participant is willing to participate in the study and undergo all planned examinations

Exclusion criteria

Participant has any other condition, including medical or psychiatric, which in the investigator's judgment would make the subject unsuitable for inclusion in the study

Locations

Related clinical trials

View on source registry