Keeping Adults Physically Active: Randomised Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Recruitment and retention rates in the intervention and control group
研究概览
简要总结
The Keeping Adults Physically Active (KAPA) feasibility study aimed to examine the feasibility and acceptability of the an intervention designed to encourage the continuation of physical activity following the completion of a Falls Management Exercise program.
详细描述
Background and premise:
Research shows that the continuation of physical activity wanes, and the positive health effects diminish, between eight-to-twelve months after the completion of community-based physical activity programs. A key finding of the Pro-Act 65 trial was that 24-months after the trial ended the beneficial effects of the Falls Management Exercise program diminished in the older people who reverted back to their old physical activity behaviours. Sustaining physical activity levels after the end of a structured physical activity program is critical to maintain any gains in functional status and falling risk. Furthermore, sustaining changes in physical activity behaviour is vital to the cost-effectiveness of physical activity interventions and to improve public health outcomes. Yet, little is known about what intervention components work best to promote the continuation of new physical activity behaviours once structured exercise programs have ceased. This suggests there is substantial opportunity to maintain the health and wellbeing of older people by implementing interventions that encourage the maintenance of physical activity.
The investigators have developed a complex evidence-based intervention that aims to engage older adults in positive physical activity behaviours after the completion of the Falls Management Exercise program. The intervention developed is based on the findings of a systematic review [PROSPERO registration: CDR42016038137] of physical activity maintenance interventions delivered to people aged 65 years and older and a review of national expert guidance on behaviour change. The intervention will be delivered to people who are exiting a 24-week community based Falls Management Exercise program within Leicestershire, Rutland Counties and Derby City and will be investigated in a feasibility trial.
The ProAct65+ trial shows that physical activity can be maintained for 12 months after the cessation of a Falls Management Exercise program. Data will be collected directly after the completion of the maintenance intervention which is also the six month time-point after the completion of the FaME program. Therefore it is possible that both the control and the intervention group may maintain their physical activity levels after the Falls Management Exercise program has ceased. Although maintenance may be higher in the intervention group, the treatment effect of the KAPA intervention will not be assessed due to the given timeframe of this study. However the feasibility trial will be used to collect the crucial data needed to inform a subsequent randomised control trial.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
KAPA intervention arm
KAPA participants who completed the 24-week commissioned Falls Management Exercise program received six sessions of motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructors delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session.
干预措施: Keeping Adults Physically Active (KAPA) intervention (Behavioral)
Usual care
The usual care participants finished the original Falls Management Exercise program and went on to being offered the service provider's usual care package.
干预措施: Usual Care (Other)
结局指标
主要结局
Recruitment and retention rates in the intervention and control group
时间窗: 6 months
The researchers recorded the number of study sites, Postural Stability Instructors and KAPA participants invited and recruited into the feasibility study. Retention rates were recorded as the number of KAPA participants (i.e. intervention and usual care participants) who remained within the study and provided outcome data at the 6-month time point.
Attendance rates to the KAPA intervention sessions
时间窗: 6 months
The Postural Stability Instructors documented in the class registers the KAPA participants' attendance at each of the monthly telephone or face-to-face community based KAPA intervention sessions. Class registers were used to record the number of face to face and telephone interactions with the participants.
Assessing acceptability of the KAPA intervention: semi-structure interviews
时间窗: 12 months
Acceptability of the intervention was determined via semi-structure interviews with the participants in receipt of the intervention and the Postural Stability Instructors delivering the intervention, to assess the acceptability of the intervention features and delivery modes. Interview data was analysed using a framework analysis approach.
次要结局
- Training evaluation of the KAPA training day(1 day)
- Adherence to key KAPA intervention strategies(6 months)
- Fidelity of the KAPA interventions delivery(6 months)
- Parameter estimates of moderate to vigorous physical activity and Intra Class Coefficient(6 months)
- Defining usual care(6 months)
- Developing a cost proforma to cost KAPA for a definitive trial(9 months)
- The number of adverse events incurred in the KAPA intervention group.(6 months)