Psychological Well Being, Proactive Attitude and Happiness Effects of Whole-body Vibration vs. Multi-component Training in Aged Women: a Randomized Controlled-trial Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Psychological General Well-Being Index (PGWBI)
研究概览
简要总结
The PAHA study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT is to compare the effectiveness of the WHOLE-BODY VIBRATION (WBV) with the Multi-component training control group and control group (CG) for psychological well being, quality of life, proactive attitude and happiness in female aged subjects.
详细描述
A recent review has moreover suggested that the content (the mental and physical demand or challenge, and the behavioral aspects of the activity) and the context (the social context) of activities are key elements when distinguishing various types. Social activity affects wellbeing or survival by reducing the risks of social isolation and by supplying emotional intimacy, socio-emotional support, reinforcement for one's self-concept and social roles, and the sense of being valued. On the other hand, productive activity may influence health and wellbeing through satisfaction with outcomes, economic gains, mental stimulation, comforting personal routines, sense of purpose, and increased self-efficacy or self-esteem. There are significant relationships between QoL and attitudes toward aging in older adults. It has been in fact demonstrated that a proactive attitude (i.e., exercise, planning ahead, and marshaling support) influences QoL outcomes (i.e., depressive symptomatology and social activities).
Evidence has moreover shown that exist gender differences in engage physical activities and in mood state in ageing. In fact, aged women are less engaged in physical activity than men, probably due to menopausal transition (MT) state. Literature has suggested that women who experience longer MT and increased symptoms have higher stress and increased risk of depression , that in turn may affect their engagement in physical activities.
Starting from current literature, we hypothesize that specific physical activity, WBV, may promote psychological well being and quality of life in female aged subjects. Moreover and therefore, we assume an improvement in proactive attitude and happiness when compared to and Multi-component training control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ranged between 55-75 years old.
排除标准
- •Male sex;
- •Age lower than 55 years old;
- •Present levels of DMO lower than 70 g/cm2;
- •Being treated for a disease that can affect bone structure or neuromuscular system;
- •Have orthopedic prosthetic implants in the lower limbs and / or spine; Have herniated discs;
- •Suffer ocular diseases that affect the retina;
- •Suffer severe cardiovascular diseases;
- •Have a pacemaker, or osteosynthesis material;
- •Severe mental illness (active psychosis/suicide risk/severe dementia);
- •Linguistic limitations (such as stuttering/untreated audio impairment);
- •A significant functional problem (such as unconsciousness/connection to respiration device/confinement to a wheelchair or bed/severe walking disability/need of help with basic daily activities), major depression, anxiety according to DSM-IV criteria.
结局指标
主要结局
Psychological General Well-Being Index (PGWBI)
时间窗: Within one year after the treatment
The PGWBI. It is a self-administered test with 22 items that assess the subjective sensation of psychological wellbeing. It has been divided in 6 categories: anxiety, depression, self-control, positivity and wellbeing, health and vitality (Grossi et al., 2006).
次要结局
- Subjective Happiness Scale (SHS)(Within one year after the treatment)
- Proactive Attitude Scale (PA)(Within one year after the treatment)
- SF-12 Health Survey(Within one year after the treatment)
研究者
Angelo Compare
Professor
University of Bergamo
