Pragmatic Randomised Controlled Trial of a Preferred Intensity Exercise Programme to Improve Physiological and Associated Psychological, Social, and Wellbeing Outcomes of Women Living With Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
研究概览
简要总结
The investigators want to find out if their specially designed exercise programme will be more successful at helping women with depression to feel better than a basic programme will, by measuring the effect the programme has on mood, physical health, and social wellbeing. Their specially designed exercise programme will involve physical exertion at the participants' chosen level of intensity (how hard the body has to work during exercise), and will include motivational support. By contrast, the basic exercise programme will be at an intensity recommended by national guidelines, of the type that may be prescribed by a general practitioner (GP), and will include no extra motivational support.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Living with depression
- •Aged 18 (age at first session of programme)
- •Living in the community
- •Resident within Nottinghamshire (personal address has Nottinghamshire postcode)
排除标准
- •Women who, at the time of the study, are unable to participate on account of any injury or physical health problem that precludes their participation
- •Women participating in research that may undermine the scientific basis of the study
研究组 & 干预措施
Psychosocial support
Comprising 22 participants engaging in the experimental exercise programme, exercising with psychosocial support.
干预措施: Psychosocial support exercise programme (Behavioral)
Prescribed exercise
Comprising 21 participants engaging in a programme of typical prescribed exercise.
干预措施: Prescribed exercise (Behavioral)
结局指标
主要结局
The primary outcome measure is score on the BDI-II (Beck Depression Inventory version 2).
时间窗: At the plenary session of the programmes.
次要结局
- Resting heart rate.(At the plenary session of the programmes.)
- GHQ12.(At the plenary session of the programmes.)
- The SF-12vII.(At the plenary session of the programmes.)
- The Rosenberg self-esteem scale.(At the plenary session of the programmes.)
- Quality of life in depression scale.(At the plenary session of the programmes.)
- The multidimensional scale of perceived social support.(At the plenary session of the programmes.)