Exercise as Treatment for Patients With Inclusion Body Myositis
- Conditions
- Inclusion Body Myositis (IBM)Feasibility Study
- Registration Number
- NCT06644482
- Lead Sponsor
- Oslo University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Feasibility: proportion completing the exercise intervention Baseline to 16 week Proportion of included participants completing the exercise intervention
Feasibility: proportion of received exercise diaries Baseline to 16 weeks Proportion of received exercise diaries (0-16 per participant)
Recruitment: proportion enrolled Baseline Proportion of eligible patients enrolled
Feasibility: exercise diaries 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 Baseline and 17 weeks Proportion of patients completing physical fitness tests
Feasibilty: Focus group interview 17 weeks Participants will participate in focus group interviews exploring the experiences of the intervention
- Secondary Outcome Measures
Name Time Method Changes in walking distance Baseline and 17 weeks Assessed by the 2 minutes walking test. Changes in walking distance measured as meters.
Changes in functional lower extremity strength 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.
Changes in muscle endurance 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).
Changes in muscle strength 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).
Changes in grip stength Baseline and 17 weeks Assessed by hydraulic hand dynamometer (Baseline). Change in grip strength is recorded in kilograms.
Change in the Berg Balance Scale 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).
Change in the Inclusion Body Myositis Functional Rating Scale (IBMFRS) 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
Change in the Health Assessment Questionnaire (HAQ) score 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.
Change in Patient Specific Functional Scale (PSFS) 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).
Change in self-reported physical activity 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.
Change in Health-Related Quality of Life 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.
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway