Exercise as Treatment for Patients With Inclusion Body Myositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility: proportion completing the exercise intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBM diagnosis
- •Able to walk with aids
排除标准
- •Unable to understand and write Norwegian
结局指标
主要结局
Feasibility: proportion completing the exercise intervention
时间窗: Baseline to 16 week
Proportion of included participants completing the exercise intervention
Feasibility: proportion of received exercise diaries
时间窗: Baseline to 16 weeks
Proportion of received exercise diaries (0-16 per participant)
Recruitment: proportion enrolled
时间窗: Baseline
Proportion of eligible patients enrolled
Feasibility: exercise diaries
时间窗: 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
时间窗: Baseline and 17 weeks
Proportion of patients completing physical fitness tests
Feasibilty: Focus group interview
时间窗: 17 weeks
Participants will participate in focus group interviews exploring the experiences of the intervention
次要结局
- Changes in walking distance(Baseline and 17 weeks)
- Changes in functional lower extremity strength(Baseline and 17 weeks)
- Changes in muscle endurance(Baseline and 17 weeks)
- Changes in muscle strength(Baseline and 17 weeks)
- Changes in grip stength(Baseline and 17 weeks)
- Change in the Berg Balance Scale(Baseline and 17 weeks)
- Change in the Inclusion Body Myositis Functional Rating Scale (IBMFRS)(Baseline and 17 weeks)
- Change in the Health Assessment Questionnaire (HAQ) score(Baseline and 17 weeks)
- Change in Patient Specific Functional Scale (PSFS)(Baseline and 17 weeks)
- Change in self-reported physical activity(Baseline and 17 weeks)
- Change in Health-Related Quality of Life(Baseline and 17 weeks)
研究者
Kristine Risum
Senior physioterapist
Oslo University Hospital