Physical Exercise Program for Family Caregivers of Dependent Patients: Randomized Clinical Trial in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in Health-related Quality of Life at different time point
研究概览
简要总结
This estudy evaluates the effects of physical exercise program on health related quality of life (HRQoL), pain and physical fitness in family caregiver.
详细描述
Justification: Research indicates that the dependent patient caregiver´s have physical, psychological and social repercussions, as consequence of the care that they provide. From Primary Health Care there is a "caregiver care program" to prevent and palliate this situation, consisting mainly in education programs in care and psychotherapy. There is controversy about the effectiveness of these programs, being necessary to develop new therapeutic strategies.
Objectives: to determine the effects of a physical exercise program, adressed by the primary health care physioterapist, on health related quality of life (HRQol), pain and physical fitness in dependent patient caregivers included in the " caregiver care program" of a basic health area.
Methodology: randomized clinical trial, with control group (GC = 32) and intervention group (GI = 36), double blind and pre and post-intervention evaluation. The GC received the usual program of the " caregiver care program". The GI also carried out a multi-component exercise program for 12 weeks, with 3 weekly sessions realized in group and monitored by physiotherapists. The outcomes variables are measured by Quality of life (SF-36), Burden (Zarit), anxiety (Goldberg Ansiety Questionanaire), depression (Yesavage Questionnaire), pain intensity (EVA), disability (Roland Morris) and physical fitness (battery of fitness tests). Patients evaluator and Outcomes Assessor are masked.
Applicability of results: If the physical exercise program, carried out from the primary health care physiotherapy, improves the HRQol, pain and physical fitness, this intervention could be an effective therapeutic strategy in the "caregiver care programs". Furthermore the proposed intervention is simple, reproducible and requires few resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients evaluator and Outcomes Assessor are masked
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Status as family caregiver and to be incluided in the "Caregiver care Program".
- •Provided care to family dependent al least 6 months.
- •Accept to participate in the study and sign the informed consent.
- •No changes in medication for at least 3 months prior to study entry.
排除标准
- •People whith associated pathologies that make it impossible to perform physical exercise program (moderate-intensity exercise).
- •To be incluiding in other family care program
- •Participation in any regular physical activity program.
- •To have a formal caregiver to care for the dependent family member
研究组 & 干预措施
PE and PCFPC
Physical Exercise and primary care family caregivers program
干预措施: PE (Other)
PE and PCFPC
Physical Exercise and primary care family caregivers program
干预措施: Usual Care (Other)
Usual Care
Usual Care: PCFPC (primary care family caregivers program)
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Health-related Quality of Life at different time point
时间窗: Change from baseline to post-treatment (16 weeks from baseline).
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) V2. Spanish version. The SF-36 is a 36- item scale constructed to survey health status and quality of life. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary. Each scale is directly transformed into a 0-100 scale. Higher scores indicate better overall quality of life.
次要结局
- Change in burden caregiver at different time points(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in depression(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in anxiety at different time points(Change from baseline to post-treatment (16 weeks from baseline).)
- Change in pain assesment at different simple points(Change from baseline to post-treatment (16 weeks from baseline).)
- Modifications of body mass index(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in handgrip strength(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in lower extremity function(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in mobility(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in maximal oxygen uptake (Vo2 max)(Change from baseline to post-treatment (16 weeks from baseline).)
- Change in disability(Change from baseline to post-treatment (16 weeks from baseline).)
- Changes in postural balance(Change from baseline to post-treatment (16 weeks from baseline))
- Changes in flexibility(Change from baseline to post-treatment (16 weeks from baseline).)