Exercise as Treatment for Patients With Inclusion Body Myositis

June 21, 2025 updated by: Kristine Risum, Oslo University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility: proportion completing the exercise intervention
Time Frame: Baseline to 16 week
Proportion of included participants completing the exercise intervention
Baseline to 16 week
Feasibility: proportion of received exercise diaries
Time Frame: Baseline to 16 weeks
Proportion of received exercise diaries (0-16 per participant)
Baseline to 16 weeks
Recruitment: proportion enrolled
Time Frame: Baseline
Proportion of eligible patients enrolled
Baseline
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).
Baseline to 16 week
Feasibility: proportion of patients completing physical fitness tests
Time Frame: Baseline and 17 weeks
Proportion of patients completing physical fitness tests
Baseline and 17 weeks
Feasibilty: Focus group interview
Time Frame: 17 weeks
Participants will participate in focus group interviews exploring the experiences of the intervention
17 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in walking distance
Time Frame: Baseline and 17 weeks
Assessed by the 2 minutes walking test. Changes in walking distance measured as meters.
Baseline and 17 weeks
Changes in functional lower extremity strength
Time Frame: Baseline and 17 weeks
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
Time Frame: Baseline and 17 weeks
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
Time Frame: Baseline and 17 weeks
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
Time Frame: Baseline and 17 weeks
Assessed by hydraulic hand dynamometer (Baseline). Change in grip strength is recorded in kilograms.
Baseline and 17 weeks
Change in the Berg Balance Scale
Time Frame: Baseline and 17 weeks
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)
Time Frame: Baseline and 17 weeks
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
Time Frame: Baseline and 17 weeks
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)
Time Frame: Baseline and 17 weeks
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
Time Frame: Baseline and 17 weeks
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
Time Frame: Baseline and 17 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety].
Time Frame: Baseline to 16 week
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.
Time Frame: Baseline to 16 week
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
Time Frame: Baseline to 16 week
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
Time Frame: Baseline to 16 week
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
Time Frame: Baseline to 16 week
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Dam Foundation
The Norwegian Rheumatism Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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