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Physical Activity Intervention for Loneliness | Completed
Physical Activity Intervention for ... | Completed
Physical Activity Intervention for Loneliness
PAIL

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Medical Conditions
  • Loneliness
  • Ageing
  • Physical Activity
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT03458793
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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).
Research Details
  • 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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Behavioral : Group walking and group educational workshops

Study Arm Groups : The experimental group

Intervention Type
See Interventions above
Primary Outcome Measures
    Attendance; 12 months; Recruitment rate; 12 months; Retention rate; 12 months; The appropriateness and practicality of the designed intervention in the proposed settings; 12 months; The acceptability of the intervention by participants and willingness to participate; 12 months; The assessment rate of questionnaires; 12 months; The appropriateness of statistical methods of data analysis; 12 months; Likely required sample size for the future pilot trial; 12 months; The effect size will be calculated for loneliness; 12 months; The effect size will be calculated for social support; 12 months; The effect size will be calculated for social networks; 12 months; The effect size will be calculated for depression; 12 months; The effect size will be calculated for anxiety; 12 months; The effect size will be calculated for self-efficacy for exercise; 12 months; The effect size will be calculated for satisfaction with level of social contacts; 12 months; The effect size will be calculated for expected outcomes and barriers for exercise; 12 months
Secondary Outcome Measures
    Loneliness; 12 months; Social support; 12 months; Social networks; 12 months; Depression and anxiety; 12 months; Self-efficacy for exercise; 12 months; Satisfaction with level of social contacts; 12 months; Expected outcomes and barriers for exercise; 12 months; Accelerometry; 12 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
60 Years - N/A
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    1. community-dwelling older adults aged 60 years and older as defined according to the United Nations standard numerical criterion (World Health Organization, 2016);

    2. 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);

    3. 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);

    4. 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);

    5. healthy or having one or more common chronic diseases but ambulatory;

    6. 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);

    7. able to give written informed consent;

    8. English speaking and able to complete paper and pencil questionnaires.

    Exclusion Criteria:

    1. not community-dwelling older adults 60 years or over;

    2. not previously sedentary;

    3. currently taking part in another physical activity intervention;

    4. 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);

    5. moderate to severe cognitive disability or clinical diagnosis of dementia;

    6. physical disability (i.e. SPPB score less than 9);

    7. 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);

    8. cognitive disability (i.e. less than 14 points on MOCA);

    9. not able to give written informed consent;

    10. not English speaking that precludes taking pen and paper tests.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
ERN_16-1419
Sponsor(s)
University of Birmingham
Key Dates

Recruitment Start Date

Jan 2018

Recruitment End Date

Dec 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

23 Jan 2018

Date updated in source

17 Apr 2019