Exercise as Treatment for Patients With Inclusion Body Myositis

NCT06644482 | Completed

• 1 other identifier: 728436
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Inclusion Body Myositis (IBM); Feasibility Study

Keywords

exercise; feasibility study

Outcome Measures

Primary Outcomes (6)

• Feasibility: proportion completing the exercise intervention

  Proportion of included participants completing the exercise intervention

  Baseline to 16 week

• Feasibility: proportion of received exercise diaries

  Proportion of received exercise diaries (0-16 per participant)

  Baseline to 16 weeks

• Recruitment: proportion enrolled

  Proportion of eligible patients enrolled

  Baseline

• Feasibility: exercise diaries

  The participants will log experiences with the intervention (e.g. completed/not completed exercises, reasons for any non-completion, other training activities, barriers/facilitators).

  Baseline to 16 week

• Feasibility: proportion of patients completing physical fitness tests

  Proportion of patients completing physical fitness tests

  Baseline and 17 weeks

• Feasibilty: Focus group interview

  Participants will participate in focus group interviews exploring the experiences of the intervention

  17 weeks

Secondary Outcomes (11)

• Changes in walking distance

  Baseline and 17 weeks

• Changes in functional lower extremity strength

  Baseline and 17 weeks

• Changes in muscle endurance

  Baseline and 17 weeks

• Changes in muscle strength

  Baseline and 17 weeks

• Changes in grip stength

  Baseline and 17 weeks

Other Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events [Safety].

  Baseline to 16 week

• Incidence of Treatment-Emergent Adverse Events [Tolerability]- pain.

  Baseline to 16 week

• Incidence of Treatment-Emergent Adverse Events [Tolerability]- muscle fatigue

  Baseline to 16 week

Study Arms (1)

Exercise group in a hospital

OTHER

Participants will take part in an exercise group delivered once a week in a hospital setting for 16 weeks

Other: Exercise group in a hospital setting

Interventions

Exercise group in a hospital setting OTHER

Participants will exercise in a group once a week for 16 weeks in a hospital setting.

Exercise group in a hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBM diagnosis
• Able to walk with aids

You may not qualify if:

• Unable to understand and write Norwegian

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Dam Foundation: collaborator
• The Norwegian Rheumatism Association: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

MeSH Terms

Conditions

Myositis, Inclusion Body; Motor Activity

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physioterapist

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: January 6, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)