School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham
Birmingham, B15 2TT, United Kingdom
NCT Number: NCT03458793
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).
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Birmingham, B15 2TT, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 12 months
Percent of subjects responding to ads and friends' referrals out of total number of invitations given out as a percentage
Time frame: 12 months
Number of participants completing the study as a proportion of those randomised
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
The appropriateness of statistical methods of data analysis will be analysed by research team
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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).
Time frame: 12 months
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).
Time frame: 12 months
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.
University of Birmingham
Other
Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study
Acronym: PAIL
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