Clinical trial NCT06644482: Exercise as Treatment for Patients With Inclusion Body Myositis
Official title: Exercise as Treatment for Patients With Inclusion Body Myositis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inclusion Body Myositis (IBM)
Feasibility Study
Keywords: exercise
feasibility study
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
name: The Norwegian Rheumatism Association
First posted: 2024-10-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is little knowledge about exercise for patients with inclusion body myositis (IBM). Patients with IBM have limited access to rehabilitation and physiotherapy resources, despite a significant need for these services due to the progressive nature of the condition, which leads to a gradual decline in physical function. The purpose of the project is to develop and implement a 16-week exercise intervention at Oslo University Hospital (OUS) for patients with IBM living in Oslo and the surrounding area. The exercise sessions will take place once a week at OUS, under the guidance of physiotherapists with extensive clinical experience with this patient group. Patients are encouraged to exercise at home at least once a week between sessions at OUS to achieve sufficient amount of exercise that normally will improve physical fitness. The feasibility and benefits of the exercise intervention will be evaluated using various methods, such as focus group interviews, physical tests, and questionnaires. The study will also provide valuable insight into whether exercise can lead to improvements in muscle strength, fitness, and balance in patients with IBM.


Eligibility criteria: Inclusion Criteria

* IBM diagnosis
* Able to walk with aids

Exclusion Criteria

-Unable to understand and write Norwegian

Primary outcomes:
measure: Feasibility: proportion completing the exercise intervention
timeFrame: Baseline to 16 week
measure: Feasibility: proportion of received exercise diaries
timeFrame: Baseline to 16 weeks
measure: Recruitment: proportion enrolled
timeFrame: Baseline
measure: Feasibility: exercise diaries
timeFrame: Baseline to 16 week
measure: Feasibility: proportion of patients completing physical fitness tests
timeFrame: Baseline and 17 weeks
measure: Feasibilty: Focus group interview
timeFrame: 17 weeks
Secondary outcomes:
measure: Changes in walking distance
timeFrame: Baseline and 17 weeks
measure: Changes in functional lower extremity strength
timeFrame: Baseline and 17 weeks
measure: Changes in muscle endurance
timeFrame: Baseline and 17 weeks
measure: Changes in muscle strength
timeFrame: Baseline and 17 weeks
measure: Changes in grip stength
timeFrame: Baseline and 17 weeks
measure: Change in the Berg Balance Scale
timeFrame: Baseline and 17 weeks
measure: Change in the Inclusion Body Myositis Functional Rating Scale (IBMFRS)
timeFrame: Baseline and 17 weeks
measure: Change in the Health Assessment Questionnaire (HAQ) score
timeFrame: Baseline and 17 weeks
measure: Change in Patient Specific Functional Scale (PSFS)
timeFrame: Baseline and 17 weeks
measure: Change in self-reported physical activity
timeFrame: Baseline and 17 weeks
measure: Change in Health-Related Quality of Life
timeFrame: Baseline and 17 weeks
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety].
timeFrame: Baseline to 16 week
measure: Incidence of Treatment-Emergent Adverse Events [Tolerability]- pain.
timeFrame: Baseline to 16 week
measure: Incidence of Treatment-Emergent Adverse Events [Tolerability]- muscle fatigue
timeFrame: Baseline to 16 week
measure: Incidence of Treatment-Emergent Adverse Events [Tolerability]- muscle fatigue
timeFrame: Baseline to 16 week
measure: Incidence of Treatment-Emergent Adverse Events [Tolerability]- fatigue
timeFrame: Baseline to 16 week
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: