Inclusion Body Myositis (IBM)NCT06644482
Exercise as Treatment for Patients With Inclusion Body Myositis
A study testing Exercise group in a hospital setting in people with Inclusion Body Myositis (IBM) and Feasibility Study, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inclusion Body Myositis (IBM), Feasibility Study
- What is being tested?
- Exercise group in a hospital setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 6 Jan 2025to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBM diagnosis
- Able to walk with aids
Who cannot join
- -Unable to understand and write Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exercise group in a hospital setting
- Keywords
- exercise, feasibility study
- Medical subject headings
- Myositis, Inclusion Body, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise group in a hospital settingOther
Participants will exercise in a group once a week for 16 weeks in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Exercise group in a hospital setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: proportion completing the exercise intervention
Proportion of included participants completing the exercise intervention
Measured: Baseline to 16 week
Feasibility: proportion of received exercise diaries
Proportion of received exercise diaries (0-16 per participant)
Measured: Baseline to 16 weeks
Recruitment: proportion enrolled
Proportion of eligible patients enrolled
Measured: 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).
Measured: Baseline to 16 week
Feasibility: proportion of patients completing physical fitness tests
Proportion of patients completing physical fitness tests
Measured: Baseline and 17 weeks
Feasibilty: Focus group interview
Participants will participate in focus group interviews exploring the experiences of the intervention
Measured: 17 weeks
Secondary outcomes (11)
Changes in walking distance
Assessed by the 2 minutes walking test. Changes in walking distance measured as meters.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline and 17 weeks
Changes in grip stength
Assessed by hydraulic hand dynamometer (Baseline). Change in grip strength is recorded in kilograms.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start6 Jan 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclusion Body Myositis (IBM)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation, The Norwegian Rheumatism Association
- Responsible party
- Principal investigator, Kristine Risum, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644482
- Sponsor's protocol ID
- 728436
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be made available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as Treatment for Patients With Inclusion Body Myositis
- ClinicalTrials.gov ID
- NCT06644482
- Acronym / sponsor ID
- 728436
- Conditions
- Inclusion Body Myositis (IBM), Feasibility Study
- Keywords
- exercise, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation, The Norwegian Rheumatism Association
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise group in a hospital | Other | Other: Exercise group in a hospital settingParticipants will take part in an exercise group delivered once a week in a hospital setting for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBM diagnosis
- Able to walk with aids
Key exclusion criteria (1 listed)
- -Unable to understand and write Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise group in a hospital settingParticipants will exercise in a group once a week for 16 weeks in a hospital setting. | Other | Exercise group in a hospital |
Primary outcome
Feasibility: proportion completing the exercise intervention
Time frame: Baseline to 16 week
Proportion of included participants completing the exercise intervention
Feasibility: proportion of received exercise diaries
Time frame: Baseline to 16 weeks
Proportion of received exercise diaries (0-16 per participant)
Recruitment: proportion enrolled
Time frame: Baseline
Proportion of eligible patients enrolled
Feasibility: exercise diaries
Time frame: Baseline to 16 week
The participants will log experiences with the intervention (e.g. completed/not completed exercises, reasons for any non-completion, other training activities, barriers/facilitators).
Feasibility: proportion of patients completing physical fitness tests
Time frame: Baseline and 17 weeks
Proportion of patients completing physical fitness tests
Feasibilty: Focus group interview
Time frame: 17 weeks
Participants will participate in focus group interviews exploring the experiences of the intervention
11 secondary outcomes
Changes in walking distance
Time frame: Baseline and 17 weeks
Changes in functional lower extremity strength
Time frame: Baseline and 17 weeks
Changes in muscle endurance
Time frame: Baseline and 17 weeks
Changes in muscle strength
Time frame: Baseline and 17 weeks
Changes in grip stength
Time frame: Baseline and 17 weeks
Change in the Berg Balance Scale
Time frame: Baseline and 17 weeks
Change in the Inclusion Body Myositis Functional Rating Scale (IBMFRS)
Time frame: Baseline and 17 weeks
Change in the Health Assessment Questionnaire (HAQ) score
Time frame: Baseline and 17 weeks
Change in Patient Specific Functional Scale (PSFS)
Time frame: Baseline and 17 weeks
Change in self-reported physical activity
Time frame: Baseline and 17 weeks
Change in Health-Related Quality of Life
Time frame: Baseline and 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. Data can be made available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in a hospital setting in people with Inclusion Body Myositis (IBM) and Feasibility Study, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: proportion completing the exercise intervention (time frame: Baseline to 16 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.