Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Dam Foundation | OTHER |
| The Norwegian Rheumatism Association | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise group in a hospital setting | Other | Participants will exercise in a group once a week for 16 weeks in a hospital setting. |
|
| 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 |
| 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. |
| 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. |
Inclusion Criteria
Exclusion Criteria
-Unable to understand and write Norwegian
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0424 | Norway |
Data can be made available on reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
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 |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |