Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The appropriateness and practicality of the designed intervention in the proposed settings
研究概览
简要总结
The purpose of this study will be to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults. The research is a feasibility study designed as a two-arm randomised controlled trial (RCT) with a wait-list control group (intervention will be offered at 12 weeks to control group).
详细描述
After an initial screening for the eligibility based on current physical activity and levels of loneliness, up to 40 eligible participants will be randomised into the experimental or control group. Participants in the intervention group will be offered a 12-week outdoor group walking and health education workshops intervention. Each session will be performed once weekly for up to 90 minutes per session. Participants in the control group will be asked to maintain their current level of physical activity. Baseline and immediate post-intervention assessments will include anthropometry (height, weight, BMI), assessment of the resting blood pressure, physical activity for a 7-day period using accelerometer, questionnaires to assess loneliness, social support, social networks, social contacts, anxiety and depression, and expected outcomes of, and barriers to, exercise. Focus groups with participants will be conducted at 4 weeks mid-point and post-intervention to assess how the intervention might be improved; focus group transcripts will be thematically analysed using a phenomenological approach.
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)
盲法说明
Computerised randomisation will be performed by an external researcher not involved in the delivery of the intervention or outcome assessment. Participants who will be assessors of their psychosocial outcomes using self-report questionnaires will be blind to the allocation concealment at the time of completing the initial questionnaires. Intervention providers who will be responsible for outcome assessments will not be blind to the intervention assignment as this would not be possible given the study and walks will be conducted by the PhD student.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •community-dwelling older adults aged 60 years and older as defined according to the United Nations standard numerical criterion (World Health Organization, 2016);
- •previously sedentary (i.e. engaged in less than 20 minutes per week of regular physical activity for the past month and < 125 minutes/week of moderate intensity physical activity) (Stevens et al., 1998). Moderate intensity activity that is noticeable accelerates the heart rate and is equal to approximately 3-6 metabolic equivalents (METs) (American College of Sports Medicine, 2013);
- •at risk of feeling socially isolated or lonely (indicated by a score of 6 or higher out of 9) on the 3-item loneliness scale for the phone screening by Hughes et al. (2004) (Appendix 1 - Phone-based eligibility screening form);
- •physically mobile as measured using the Short Physical Performance Battery (SPPB) (Guralnik et al., 1994) with a score ≥ 9 out of 12 (Pahor et al., 2014);
- •healthy or having one or more common chronic diseases but ambulatory;
- •without a cognitive disability as assessed by the Montreal Cognitive Assessment (MOCA) (Nasreddine et al., 2005) with a score ≥ 22 out of 30 (Freitas et al., 2013);
- •able to give written informed consent;
- •English speaking and able to complete paper and pencil questionnaires.
排除标准
- •not community-dwelling older adults 60 years or over;
- •not previously sedentary;
- •currently taking part in another physical activity intervention;
- •not at risk for feeling socially isolated or lonely (i.e. score of less than 6 (out of 9) on the 3-item loneliness scale for the phone screening by Hughes et al., (2004);
- •moderate to severe cognitive disability or clinical diagnosis of dementia;
- •physical disability (i.e. SPPB score less than 9);
- •severe frailty or any chronic health condition that precludes participation in the physical activity intervention and significantly limits the physical mobility of the participant (i.e. hospital settings/ non-ambulatory regime);
- •cognitive disability (i.e. less than 14 points on MOCA);
- •not able to give written informed consent;
- •not English speaking that precludes taking pen and paper tests.
研究组 & 干预措施
The experimental group
The experimental group will take part in the 12 week intervention after randomisation consisting of group walking and educational workshops performed once weekly for up to 90 minutes in total for each session.
干预措施: Group walking and group educational workshops (Behavioral)
The control group
The control group will be a wait-listed arm that will be offered an intervention at 12 weeks after the randomisation (the delayed intervention).
结局指标
主要结局
The appropriateness and practicality of the designed intervention in the proposed settings
时间窗: 12 months
Is intervention effective for reducing loneliness, is intervention practical in the proposed design settings as assessed during the focus group interviews and analysed qualitatively
The assessment rate of questionnaires
时间窗: 12 months
The assessment rate of questionnaires will be evaluated as the total number of completed questionnaires divided by the total number of questionnaires and recorded as a percentage
The appropriateness of statistical methods of data analysis
时间窗: 12 months
The appropriateness of statistical methods of data analysis will be analysed by research team
The effect size will be calculated for social support
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in social support using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
The effect size will be calculated for satisfaction with level of social contacts
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in satisfaction with level of social contacts using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
The effect size will be calculated for expected outcomes and barriers for exercise
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in expected outcomes and barriers for exercise using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
Attendance
时间窗: 12 months
Attendance will be calculated as the total number of attended sessions divided by the total number of sessions of the intervention and recorded as a percentage.
Recruitment rate
时间窗: 12 months
Percent of subjects responding to ads and friends' referrals out of total number of invitations given out as a percentage
Retention rate
时间窗: 12 months
Number of participants completing the study as a proportion of those randomised
The acceptability of the intervention by participants and willingness to participate
时间窗: 12 months
Focus group interviews using phenomenological inductive approach will be aimed to help the research team to improve the quality of the delivered intervention by making changes in the methodology and design of the intervention for the future implementation in a consequent study
Likely required sample size for the future pilot trial
时间窗: 12 months
A power calculation and sample size estimation will be calculated for meaningful outcomes (e.g. loneliness or social support) using the method based on the differences in means between the intervention and control group using the G-power software
The effect size will be calculated for loneliness
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in loneliness using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
The effect size will be calculated for social networks
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in social networks using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
The effect size will be calculated for depression
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in depression using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
The effect size will be calculated for anxiety
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in anxiety using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
The effect size will be calculated for self-efficacy for exercise
时间窗: 12 months
Means (M) and standard deviations (SD) will be used to investigate the effect size for change in self-efficacy for exercise using mixed between (intervention group) and within (time) repeated-measures analysis of variance (ANOVAs) with post-hoc comparisons
次要结局
- Loneliness(12 months)
- Social support(12 months)
- Satisfaction with level of social contacts(12 months)
- Social networks(12 months)
- Depression and anxiety(12 months)
- Self-efficacy for exercise(12 months)
- Expected outcomes and barriers for exercise(12 months)
- Accelerometry(12 months)
研究者
Anna Whittaker
Professor
University of Birmingham