Comparing Effectiveness of Physiotherapy versus Drug Management on Fatigue, Physical Functioning, and Episodic Disability for Myalgic Encephalomyelitis in Post-COVID-19 Condition
试验速览
- 阶段
- 4 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Chalder fatigue Scale (CFS)
研究概览
简要总结
ME/CFS patients will be recruited and treated in three specialized Hospitals. The study will be conducted in BRB Hospital Limited and Specialized Physiotherapy Hospital Ltd in the Dhaka division. In the Khulna division, the treatment center will be the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology. The APTE-I, APTE-T, and DM groups will be recruited from any centers. However, the DM group will have respondents from the participants who are not willing to take any exercise interventions and only accept to take drug management. To prevent cross-contamination of the data, different treatments set up will be arranged in each study setting, and separate personnel will be employed for each treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of long COVID according to who working group criteria1, 2) Diagnosis of chronic fatigue syndrome(CFS) according to the 2006 Canadian consensus criteria5, 3) Respondents meeting with persistent or relapsing chronic fatigue and post exertion malaise or fatigue criteria of the Canadian consensus guideline, and 4) willing to participate with the trail with a consent of adherence with the intervention.
排除标准
- •(1) any preexisting post-exertion symptoms exaggeration, (2) any preexisting clinical condition with fatigue as cardiovascular or neurological disability, (3) any red flags or signs that are explained as contraindication according to safe Post-COVID-19 condition rehabilitation guideline, and (4) patient drop-out within the 1st week of inclusion.
结局指标
主要结局
Chalder fatigue Scale (CFS)
时间窗: At baseline, 12 weeks and 6 months
次要结局
- Physical Functioning sub-domain of SF-36(At baseline, 12 weeks and 6 months)
- Disability Adjacent Life Years (DALYs)(At baseline, 12 weeks and 6 months)
研究者
Altaf Hossain Sarker
Jashore University of Science and Technology (JUST)