Exercise as Treatment for Patients With Inclusion Body Myositis

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.

Study Overview

• Status: Completed
• Conditions: Feasibility Study; Inclusion Body Myositis (IBM)
• Intervention / Treatment: Other: Exercise group in a hospital setting

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• IBM diagnosis
• Able to walk with aids

Exclusion Criteria

-Unable to understand and write Norwegian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise group in a hospital; 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; Participants will exercise in a group once a week for 16 weeks in a hospital setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in walking distance	Assessed by the 2 minutes walking test. Changes in walking distance measured as meters.	Baseline and 17 weeks
Changes in functional lower extremity strength	The patients are to stand up and sit down from a chair as many times as they can within 30 seconds, and the total number of times is recorded.	Baseline and 17 weeks
Changes in muscle endurance	Assessed by the Functional Index- 2 in three muscle groups; shoulder flexors (maximum 60 repetitions), neck flexors (maximum 30 repetitions) and hip flexors (maximum 60 repetitions).	Baseline and 17 weeks
Changes in muscle strength	Assessed by the Manual Muscle test - 8 (MMT - 8), which includes unilateral testing of muscle strength in 8 eight muscle groups; (Deltoid, Biceps, Wrist extensors, Quadriceps, Ankle dorsiflexors, Neck flexors, Gluteus medius and Gluteus maximux). Each muscle group is scored on a 0-10-point scale (10=best score). The total MMT - 8 will be calculated (0-80, 80=best score).	Baseline and 17 weeks
Changes in grip stength	Assessed by hydraulic hand dynamometer (Baseline). Change in grip strength is recorded in kilograms.	Baseline and 17 weeks
Change in the Berg Balance Scale	The Berg Balance Scale (BBS) is a 14-item objective measure that assesses static and dynamic balance and fall risk in adults. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion.The total score ranges from 0-52 (52 indicates best score).	Baseline and 17 weeks
Change in the Inclusion Body Myositis Functional Rating Scale (IBMFRS)	The IBMFRS consists of 10 questions about a patient's ability to perform daily activities (including walking, dressing, swallowing and handling utensils). Each question is answered using a number from 0-4. The numbers are added up to give the total score ranging from 0 to 40, with 40 being the best possible score	Baseline and 17 weeks
Change in the Health Assessment Questionnaire (HAQ) score	Change in the last week disability on the total HAQ score (0-3, 0 indicates best possible function). The HAQ comprises 30 questions, covering eight functional ability domains related to daily living during the past week (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities). The score ranges from 0-3 (0 indicates no disability, 3 indicates severe disability) in each domain, of which the total CHAQ is calculated.	Baseline and 17 weeks
Change in Patient Specific Functional Scale (PSFS)	The patients will identify 3-5 important activities they are unable to perform or have difficulty with due to inclusion body myositis. The patients are then asked to rate the current level of difficulty associated with each activity on an 11-point scale, from 0 (not able to perform the activity) to 10 (no problems).	Baseline and 17 weeks
Change in self-reported physical activity	Assessed by the International Physical Activity Questionnaire-Short form (IPAQ-SF). Change in time (minutes per week/day) and Metabolic Equivalent of Task (MET-minutes per week/day) spent on sitting, walking, and moderate- and vigorous intensity physical activity the last week. METs are calculated by using the corresponding MET-values for walking (3.3 MET), and moderate-(4.0 MET) and vigorous (8.0 MET) intensity physical activity.	Baseline and 17 weeks
Change in Health-Related Quality of Life	Assessed by the Short Form Health Survey (SF36) which comprises 36 questions covering the areas of physical function, role limitations (physical), pain, general health perception, energy and fatigue (vitality), social function, role limitations (emotional), and mental health. The results are recoded so that the final score for each area ranges from 0 to 100, where 100 indicates the best possible health.	Baseline and 17 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety].	Patients will log 1) total of falls during the training period and 2) total number of near-falls during the training period.	Baseline to 16 week
Incidence of Treatment-Emergent Adverse Events [Tolerability]- pain.	Self-reported pain will be assessed by numeric rating scale ranging from 0 (no pain) to 10 (worst pain)	Baseline to 16 week
Incidence of Treatment-Emergent Adverse Events [Tolerability]- muscle fatigue	Self-reported muscle fatigue will be assessed by numeric rating scale ranging from 0 (no muscle fatigue) to 10 (worst muscle fatigue)	Baseline to 16 week
Incidence of Treatment-Emergent Adverse Events [Tolerability]- muscle fatigue	Self-reported muscle soreness will be assessed by numeric rating scale ranging from 0 (no muscle soreness) to 10 (worst muscle soreness)	Baseline to 16 week
Incidence of Treatment-Emergent Adverse Events [Tolerability]- fatigue	Self-reported fatigue will be assessed by numeric rating scale ranging from 0 (no fatigue) to 10 (worst fatigue)	Baseline to 16 week

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Dam Foundation; The Norwegian Rheumatism Association

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: exercise; feasibility study
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Myositis; Myositis, Inclusion Body
• Other Study ID Numbers: 728436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be made available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No