Effect of Fatigue Awareness and Therapeutics Program on Chronic Fatigue Syndrome and Quality of Life in Family Caregivers of Children with Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1.Chalder Fatigue Scale
研究概览
简要总结
This is a Randomized Controlled Trial.
Subjects will be includes according to inclusion and exclusion criteria. The entire procedure involved in the study will be explained to each subject. A written informed consent will be obtained from the participants. Demographic data of the participants will be collected. Patients will be assessed for Chalder Fatigue Scale, Fatigue Severity Scale, WHOQOL- BREF, Caregivers strain index questionnaire pre and post to intervention and follow up will be done 1 month after protocol. Group A will receive Fatigue awareness and education, Physical activity and Energy conservation techniques. Group B will receive routine caregiving support. Interventional group Participants will receives Fatigue awareness and education 5 session, one session per week.
Intervention will be of 3 sessions weekly for 6 weeks which includes Warm up- 5-10 mins, Static Cycling–10mins, Cool-down- 5-10 mins, Bensons relaxation and Deep Breathing Exercise and Energy Conservation Technique. Control group receives routine caregiving support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Family caregivers of a children aged 1-12 year diagnosed with CP.
- •2.Family member who is primarily caring for child with CP.
- •3.Participants willing to provide written informed consent and commit to the study protocol.
- •4.Participants who are experiencing moderate to severe fatigue for at least 3 months.
排除标准
- •1.Family caregivers with chronic disorders, disabilities and neurological problems were excluded.
- •2.Participants with any comorbidities like uncontrolled HTN and DM were excluded.
- •3.Participants with psychological disorders were excluded.
- •4.Pregnant women caring for CP child.
- •5.Participants receiving concurrent fatigue management programs or involved in any other physical training program were excluded.
结局指标
主要结局
1.Chalder Fatigue Scale
时间窗: All outcomes will be assessed at baseline and post intervention that is after 6 weeks. Follow-up will be taken after 4 weeks of post intervention assessment.
2.Fatigue Severity Scale
时间窗: All outcomes will be assessed at baseline and post intervention that is after 6 weeks. Follow-up will be taken after 4 weeks of post intervention assessment.
3.WHOQOL- BREF
时间窗: All outcomes will be assessed at baseline and post intervention that is after 6 weeks. Follow-up will be taken after 4 weeks of post intervention assessment.
4.Caregivers strain index
时间窗: All outcomes will be assessed at baseline and post intervention that is after 6 weeks. Follow-up will be taken after 4 weeks of post intervention assessment.
次要结局
未报告次要终点
研究者
Dr Geetanjali Prashant Koli
Maharashtra Institute of Physiotherapy, Latur