An interventional study of Group walking and group educational workshops in Loneliness, Ageing and Physical Activity, sponsored by University of Birmingham. Completed at 1 site in United Kingdom. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by University of Birmingham · Not applicable, Interventional, and Treatment
Among 14 studies in Motor Activity by University of Birmingham — none open to participants now, 1 under way, none of them phase 3. Motor Activity · University of Birmingham.
Among the 14 studies in Motor Activity by University of Birmingham, this one is the 9th largest by enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2018, is one of 11 with no phase, and was the 10th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →None of the 14 studies in Motor Activity by University of Birmingham is open now.
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2018.
This study's enrollment of 25 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 33 across the 12 interventional studies, 172 across the 2 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Motor Activity by University of Birmingham, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Group walking and group educational workshops
The control group will be a wait-listed arm that will be offered an intervention at 12 weeks after the randomisation (the delayed intervention).
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
Attendance
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
Recruitment rate
Percent of subjects responding to ads and friends' referrals out of total number of invitations given out as a percentage
Time frame: 12 months
Retention rate
Number of participants completing the study as a proportion of those randomised
Time frame: 12 months
The appropriateness and practicality of the designed intervention in the proposed settings
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
The acceptability of the intervention by participants and willingness to participate
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
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
The appropriateness of statistical methods of data analysis will be analysed by research team
Time frame: 12 months
Likely required sample size for the future pilot trial
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
The effect size will be calculated for loneliness
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
The effect size will be calculated for social support
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
The effect size will be calculated for social networks
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
The effect size will be calculated for depression
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
The effect size will be calculated for anxiety
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
The effect size will be calculated for self-efficacy for exercise
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
The effect size will be calculated for satisfaction with level of social contacts
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
The effect size will be calculated for expected outcomes and barriers for exercise
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
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
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
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
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
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
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
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
Accelerometry
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.
Time frame: 12 months
Plan to share: No
Ran from Jan 2018 to primary completion in Dec 2018, 11 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 11 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.