Condition category
Musculoskeletal Diseases
Date applied
05/05/2020
Date assigned
22/05/2020
Last edited
22/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Idiopathic inflammatory myopathies are diseases characterized by muscle weakness, caused by inflammation and atrophy in the affected muscles, which lead to a limitation in the execution of daily activities. The aim of this study is to investigate the impact of specialized activities of daily living (ADL) training on muscle strength and endurance, function, quality of life, and other selected aspects specific to this disease.

Who can participate?
Adult patients with myositis who are routinely followed and treated at the Institute of Rheumatology in Prague (Czech Republic)

What does the study involve?
Participants are allocated into the intervention or control group based on their willingness to adhere to the schedule. The control group receive standard care (i.e. standard drug treatment and materials for regular daily home exercise focused on activities of daily living). The intervention group receive standard care (as described above) and 6 months of a 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). Participants are assessed 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).

What are the possible benefits and risks of participating?
Patients in the intervention group may benefit from the intensive supervised physiotherapy program by improving their muscle strength/endurance or function in general, and patients in both groups may benefit from more detailed examinations by healthcare professionals during the course of the study. Potential risks should be eliminated by the tailored modification of the intensity of the physiotherapy program which will be adapted to the actual level of general health and function of each patient.

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?
May 2014 to June 2017

Who is funding the study?
Czech Ministry of Health (Czech Republic)

Who is the main contact?
Maja Spiritovic
spiritovic@revma.cz

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michal Tomcik

ORCID ID

http://orcid.org/0000-0002-8616-7850

Contact details

Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic
+420 (0)234075101
tomcik@revma.cz

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

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

Acronym

ADL-IIM

Study hypothesis

A specialized, long-term, tailored, physiotherapy program focused on activities of daily living in patients with idiopathic inflammatory myopathies improves the muscle, strength, endurance, overall function, disability, quality of life, fatigue, depression, stability (compared to controls treated with the standard of care) and is safe (does not increase systemic or local levels of inflammatory markers).

Ethics approval

Approved 29/07/2014, Ethics Committee of the Institute of Rheumatology (Na Slupi 4, 128 50 Praha 2, Czech Republic; +420 (0)234075244; putova@revma.cz), ref: 1446/2014

Study design

interventional single-centre prospective non-randomized controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Idiopathic inflammatory myopathies/myositis

Intervention

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)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Muscle endurance assessed by FI-2 test (Functional Index-2)
2. Muscle strength assessed by MMT8 test (Manual Muscle Testing-8)

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)

Secondary outcome measures

1. Health/disability assessed using HAQ questionnaire (Health Assessment Questionnaire)
2. Quality of life assessed using SF-36 questionnaire (Medical Outcomes Short Form-36)
3. Fatigue assessed using FIS questionnaire (Fatigue Impact Scale)
4. Depression assessed using BDI-II questionnaire (Beck´s Depression Inventory-II)
5. Stability assessed by stabilometry - vector trace area
6. Body composition assessed by bioelectric impedance (BIA-2000-M) and densitometry (iDXA Lunar)
7. Safety assessed using local (in the muscle biopsy samples extracted before the start and after the end of the intervention program) and systemic expression of selected inflammatory markers

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)

Overall trial start date

01/05/2014

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 patients in the intervention group, 20 patients in the control group

Total final enrolment

52

Participant 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

Recruitment start date

01/01/2015

Recruitment end date

01/04/2016

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Institute of Rheumatology
Na Slupi 4
Prague
12850
Czech Republic

Sponsor information

Organisation

Revmatologický ústav

Sponsor details

Na Slupi 4
Prague
12850
Czech Republic
+420 (0)234075244
pavelka@revma.cz

Sponsor type

Hospital/treatment centre

Website

http://www.revma.cz

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning to publish the results in a rheumatology-oriented peer-reviewed journal with an impact factor.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/05/2020: Trial's existence confirmed by Ethics Committee of the Institute of Rheumatology in Prague.