Digital Music and Movement Resources to Increase Mental and Physical Well-being in Older Adults in Care Homes: a Pilot Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change From Baseline Salivary Cortisol Levels
研究概览
简要总结
This pilot randomised controlled trial aims to compare the effectiveness of a 12-week music and movement intervention in older adults in care homes compared to a waitlist control group.
The main questions it aims to answer are:
- Do salivary cortisol and DHEAS levels improve after the intervention, compared to the waitlist control group?
- Do feelings of anxiety and depression improve after the intervention, compared to the waitlist control group?
- Does the quality of life improve after the intervention, compared to the waitlist control group?
- Does physical function improve after the intervention, compared to the waitlist control group?
Participants will engage in music and movement sessions three times per week for 12 weeks. Researchers will compare the intervention group to the waitlist control group to see if any effects occur.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •residents in care homes ≥ 65 years,
- •able to complete 12 weeks of a movement and music program,
- •having the capacity to give informed consent as assessed by care staff and confirmed in discussion about the project with the research team using the British Psychological Society capacity checklist
排除标准
- •currently taking part in any other clinical trial which could potentially have an impact upon or influence the findings of the current study,
- •pre-existing conditions or concurrent diagnoses which would profoundly impact their capacity to undergo the intervention, even once adaptations have been made,
- •inability to adequately understand written/spoken English to participate in the measures and intervention (e.g., due to cognitive or sensory impairment).
结局指标
主要结局
Change From Baseline Salivary Cortisol Levels
时间窗: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
Saliva samples will be obtained to determine free salivary cortisol. If the test is done around 9 AM, the results would be between 100 and 750 ng/dL. Any dysregulation, notably higher cortisol levels, may indicate poor health outcomes.
Change From Baseline Psychosocial Wellbeing Using the Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline (within 1 week prior to intervention starting) and post-intervention, within 1 week of completion of the 12-week intervention period.
The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. The range of scores for each of the two subscales (anxiety and depression) is 0-21, respectively.
次要结局
- Change From Baseline Fear of Falling Using the Falls Efficacy Scale - International (Short Form)(FES-I)(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Activities of Daily Living and Health-related Quality of Life Using The Dartmouth COOP Charts(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Psychosocial Wellbeing Using the Brief UCLA Loneliness Scale (ULS-6)(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Psychosocial Wellbeing Using the Perceived Stress Scale (PSS)(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Sleep Satisfaction Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Physical Function Using the Short Performance Battery(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Physical Function Using Hand Grip Strength(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Physical Function Using Fried Frailty Phenotype Criteria(Before and 1 month after completion of the 12-week intervention period.)
- Change From Baseline Salivary DHEAS Levels at 12 Weeks(Before and 1 month after completion of the 12-week intervention period.)
- Acceptability of the Intervention Assessed by Interviews(1 month after completion after the completion of the 12-week intervention period)
研究者
Anna Whittaker
Principal Investigator
University of Stirling