Physical Activity Intervention for Loneliness (PAIL)
2019年4月17日 更新者：Anna Whittaker、University of Birmingham
Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study
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).
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Birmingham、イギリス、B15 2TT
- School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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The experimental group will take part in 12 week intervention consisting of group walking and group educational workshops. Group walking sessions will run once weekly for up to 45 minutes each in small groups (up to 8-9 people per group) and will be delivered by a trained walk leader once weekly for duration up to 45 minutes per session. Group educational workshops will be delivered in the form of a group presentation once weekly for up to 45 minutes by the research team (i.e. the PhD student) on a variety of topics focused on the healthy ageing, such as eye hygiene, mental health and well-being, preventing falls, social support, nutritional guides, physical activity recommendations for older adults and other topics |
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介入なし：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).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Attendance
時間枠：12 months
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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.
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12 months
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Recruitment rate
時間枠：12 months
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Percent of subjects responding to ads and friends' referrals out of total number of invitations given out as a percentage
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12 months
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Retention rate
時間枠：12 months
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Number of participants completing the study as a proportion of those randomised
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12 months
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The appropriateness and practicality of the designed intervention in the proposed settings
時間枠：12 months
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Is intervention effective for reducing loneliness, is intervention practical in the proposed design settings as assessed during the focus group interviews and analysed qualitatively
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12 months
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The acceptability of the intervention by participants and willingness to participate
時間枠：12 months
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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
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12 months
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The assessment rate of questionnaires
時間枠：12 months
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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
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12 months
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The appropriateness of statistical methods of data analysis
時間枠：12 months
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The appropriateness of statistical methods of data analysis will be analysed by research team
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12 months
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Likely required sample size for the future pilot trial
時間枠：12 months
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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
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12 months
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The effect size will be calculated for loneliness
時間枠：12 months
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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
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12 months
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The effect size will be calculated for social support
時間枠：12 months
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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
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12 months
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The effect size will be calculated for social networks
時間枠：12 months
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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
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12 months
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The effect size will be calculated for depression
時間枠：12 months
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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
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12 months
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The effect size will be calculated for anxiety
時間枠：12 months
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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
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12 months
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The effect size will be calculated for self-efficacy for exercise
時間枠：12 months
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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
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12 months
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The effect size will be calculated for satisfaction with level of social contacts
時間枠：12 months
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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
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12 months
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The effect size will be calculated for expected outcomes and barriers for exercise
時間枠：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
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Loneliness
時間枠：12 months
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Loneliness will be assessed using the 8-item UCLA (University of California, Los Angeles) Loneliness Scale (UCLA-8) (Hays and DiMatteo, 1987).
Items will be rated on the 4-grade Likert scale ranging from 1 (never) to 4 (often).
The total scoring is ranged from a minimum of 8 to a maximum of 32 with the higher score indicating more loneliness considered to be a worse outcome.
Questions "I am an outgoing person" and "I can find companionship when I want it" will be reverse scored.
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12 months
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Social support
時間枠：12 months
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Social support will be assessed using the 20-item Medical Outcomes Study Social Support Survey (MOSSSS) (Sherbourne and Stewart, 1991).
The questionnaire will consist of 20 items including the assessment of a structural social support (number of close friends - item 1) and assessment of functional social support (items 2-20).
Participants will be asked to complete the questionnaire using the five-point Likert scale ranging from low social support "None of the time" (1 point) to a high social support "All of the Time" (5 points).
The total score will be calculated as the sum of the scores.
Higher scores of support will show better social support.
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12 months
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Social networks
時間枠：12 months
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Social networks will be assessed using the 6-item Lubben's Social Network Scale (LSNS-6) (Lubben et al., 2006).LSNS-6 has total 6 items divided into two subscales: family and friendship (three items for each).
The total score will be calculated by sum of the six items with scores ranging from 0 to 30.
A sum of scores for six items less than 12 will indicate that the respondent had fewer than two people for social interactions.
Similarly, a cut-point score of 6 on the three-item will indicate as being at risk for social isolation (Lubben et al., 2006).
The family subscale will indicate that the participants had less than two family members to perform social interactions, similarly for the friendship subscale.
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12 months
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Depression and anxiety
時間枠：12 months
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Depression and anxiety will be assessed using the 14-item Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983).The questionnaire consists of 14 items with the assessment on four-point scale (0-3).
The maximum total score for each subscale will be 21 points.
The cut-offs for the total score for each sub-scale will be: 0-7 - normal, 8-11 - mild, 12-14 - moderate, 15 and over - severe.
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12 months
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Self-efficacy for exercise
時間枠：12 months
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Self-efficacy for exercise will be measured using the revised 9-item Self-Efficacy for Walking/Exercise Scale (SEE) in a paper-and-pencil format (Resnick and Jenkins, 2000).
Using numbers from 0 (not confident) to 10 (very confident) participants will be asked to rate their confidence in their ability to walk/exercise for 20 minutes three times per week (Resnick and Jenkins, 2000).
The scoring will be calculated by summing the numerical ratings for each response and dividing by the total number of items.
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12 months
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Satisfaction with level of social contacts
時間枠：12 months
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Satisfaction with level of social contacts will be measured with the question "How satisfied are you with your social contacts?"
(Fokkema and Knipscheer, 2007).
Participants will rate their answer on a scale from 0 (entirely dissatisfied) to 10 (entirely satisfied).
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12 months
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Expected outcomes and barriers for exercise
時間枠：12 months
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Expected outcomes and barriers for exercise will be administered using the Expected Outcomes and Barriers for Habitual Exercise scale (Steinhardt and Dishman, 1989).
Participants will be replying using the five-point Likert scale ranging from "Strongly disagree" (1 point) to "Strongly agree" (5 points).
Scoring for each subscale will be provided by summing all numerical ratings for each item and divided by the total number of items.
The total score of expected outcomes and barriers for exercise will be ranged from 1 point (low) to 5 points (high).
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12 months
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Accelerometry
時間枠：12 months
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Physical activity will be measured using ActivPAL accelerometers (PAL Technologies Ltd. Glasgow, UK).
Data will be exctracted for average step counts (steps/day), time stepping (hours), time sitting/lying (hours), and energy equivalent (METs) and analysed as continuos variable for pre-to post-intervention differences.
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Anna C. Whittaker, Professor、University of Birmingham
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Shvedko AV, Thompson JL, Greig CA, Whittaker AC. Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults: a randomised feasibility study. Pilot Feasibility Stud. 2020 May 23;6:73. doi: 10.1186/s40814-020-00587-0. eCollection 2020.
- Shvedko AV, Thompson JL, Greig CA, Whittaker AC. Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults: protocol for a feasibility study. Pilot Feasibility Stud. 2018 Dec 19;4:187. doi: 10.1186/s40814-018-0379-0. eCollection 2018.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月4日
一次修了 (実際)
2018年12月28日
研究の完了 (実際)
2018年12月29日
試験登録日
最初に提出
2018年1月23日
QC基準を満たした最初の提出物
2018年3月1日
最初の投稿 (実際)
2018年3月8日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月18日
QC基準を満たした最後の更新が送信されました
2019年4月17日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。