CHANGES IN THE EMOTIONAL STATE, QUALITY OF LIFE AND SOCIAL SUPPORT AFTER A PROGRAM OF PHYSICAL ACTIVITY IN THE ELDERLY PEOPLE: RANDOMIZED MULTI-CENTER CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from Baseline The Beck Depression Inventory score
研究概览
简要总结
Background: Social isolation, loneliness and anxiety-depressive states are emerging health conditions in the elderly of our society. This situation is related to higher morbidity and mortality. There is a growing need to determine effective interventions that address these situations, since sometimes pharmacological options are limited in these patients. Physical activity (AF) and social relationships in the elderly are linked to physical and mental health. Being able to do some physical or recreational activity will help them face this stage of life with more optimism and relate to others in a healthy and independent way, however, few studies have evaluated their effectiveness in our territory.
- Objectives: To evaluate whether a 4 month AF group program and the visit to know socio-cultural entities improve the emotional, social and quality of life situation in a sample of people over 64 years of age with anxiety, depression, social isolation or solitude And measure whether adherence to AF and the linkage to sociocultural entities is maintained after the intervention has taken place.
- Methodology:
Design: Multicentre, randomized, two-group clinical trial, of 1 year follow-up. Study population: Patients over 64 years of age assigned to primary care teams (EAP) from different locations: Sant Joan de Vilatorrada, Súria and Manresa 2.
Inclusion criteria: To meet criteria of depression or anxiety at the time of the study, score> 12 on the Beck Depression Scale and / or score> 10 on the GAD-7 Scale (General Anxiety Disorder) and that Present a score <32 on the steps of DUKE-UNC-11.
A randomization of between 44 and 56 patients will be performed at each participant EAP. Half will be allocated to the control group (GC) and half to the intervention group (GI).
The intervention group will participate in a group AF program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.
. Main measures: Response to the intervention or clinical remission of depression (Escalera de Beck), and / or anxiety (Escala GAD-7), improvement of social support (DUKE-UNC) and quality of life (EuroQol) . Secondary measures: Adherence to the AF (VREM questionnaire (Spanish Reduced Version of the Minnesota Free Time Questionnaire in Minnesota)), and linkage to sociocultural entities once the intervention has been completed. The assessments will be made at 0, 4, 8 and 12 months.
详细描述
BACKGROUND AND CURRENT STATUS OF THE SUBJECT:
In our society, thanks to medicine and development, the proportion of the elderly population tends to increase every year. The percentage of people over 64 years of age in 2017 in Spain was 18.8%, and is expected to continue to increase to 34.6% in 2066, according to the National Statistics Institute projection (1).
Social isolation, loneliness and anxiety-depressive states are emerging health conditions in the elderly in our society. As much in adult population as in old population noninstitutionalized it has been verified that to have little social support is related to a worse mental health. According to the European Health Survey in Spain carried out by the Ministry of Health, Consumption and Social Welfare of 2017, the prevalence of depression and chronic anxiety were in subjects of 65-74 years of 10.64% and 8.25% , from 75 to 84 years of 13.73% and 9.49% and over 85 years of 11.36% and 6.68% (2). This situation is related to higher morbidity and mortality. There is a growing need to determine effective interventions that address these conditions, since sometimes pharmacological options are limited in these patients.
For decades it has been known that social relationships are linked to physical and mental health. A satisfying social network promotes healthy behaviors and habits. Social support especially protects the elderly from loneliness (3) and from depression (4). In particular, it can have a beneficial impact on mental health problems and psychological distress among older adults (5).
Also AF in the elderly has multiple advantages, not only at the physical level but also at the emotional level (6-8), several studies show that physical or leisure activities reduce loneliness (9), depression (10- 14), anxiety (15) and are associated with better mental health (16, 17). According to Guszkowska (18), the AF's benefits of anxiety, depression and irritability are especially high in those who start from high levels of anxiety and depression. The type of AF that causes major improvements is those based on cyclical aerobic activities (walking, swimming or cycling) from moderate to low intensity. This statement is aligned with the position of the American College of Sports Medicine, which recommends AF for the larger populations and affirms that regular AF can minimize the physiological and psychological effects of a sedentary lifestyle time that increases the expectations of life (19) and the quality of life (20). Being able to do some physical or recreational activity will help them face this stage of life with more optimism and relate to others in a healthy and independent way (21), however, few studies in our territory have evaluated their effectiveness.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •score > 12 on the Beck Depression Scale (BDI-II)
- •and / or score > 10 on the GAD-7 Scale (General Anxiety Disorder)
- •and / or score < 32 on the back of DUKE-UNC-11.
排除标准
- •Diagnosis of dementia or moderate cognitive impairment.
- •Greater depression (BECK scale score> 28).
- •Dependency disorders due to abuse of alcohol or other drugs.
- •Participate in a therapy group of the hospital's psychiatry department.
- •Physical illness at an advanced stage.
- •Present any physical, mental or temporary limitations to be able to walk 1 hour a day two days a week.
- •Not having signed the informed consent.
研究组 & 干预措施
Physical activity group
干预措施: Physical activity (Other)
Control group
结局指标
主要结局
Change from Baseline The Beck Depression Inventory score
时间窗: 4, 8 and 12 months after starting the study.
Clinical remission is considered: Beck scale score (BDI-II) \<12 points (Riedel 2010) and response to the intervention: reduction of the basal score.
Change from Baseline General Anxiety Disorder-7 scale score
时间窗: 4, 8 and 12 months after starting the study.
Clinical remission is considered: scaling of the GAD-7 scale (General Anxiety Disorder) \<10 points and response to the intervention: reduction of the score compared to basal
Change from Baseline DUKE-UNC-11 social support questionnaire score
时间窗: 4, 8 and 12 months after starting the study.
Social support improvement is considered a decrease in the score in the DUKE-UNC-11 social support questionnaire with respect to the basal, and good social support with a score \<32 points.
Change from Baseline EuroQol quality of life questionnaire score
时间窗: 4, 8 and 12 months after starting the study.
Quality of life improvement is considered a decrease in the score in the EuroQol questionnaire with respect to basal.
次要结局
未报告次要终点