Clinical trial NCT03458793: Physical Activity Intervention for Loneliness
Official title: Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Ageing
Physical Activity
Keywords: randomised controlled study
physical activity
loneliness
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a two-arm randomised controlled trial (RCT) with a wait-list control group
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Attendance
timeFrame: 12 months
measure: Recruitment rate
timeFrame: 12 months
measure: Retention rate
timeFrame: 12 months
measure: The appropriateness and practicality of the designed intervention in the proposed settings
timeFrame: 12 months
measure: The acceptability of the intervention by participants and willingness to participate
timeFrame: 12 months
measure: The assessment rate of questionnaires
timeFrame: 12 months
measure: The appropriateness of statistical methods of data analysis
timeFrame: 12 months
measure: Likely required sample size for the future pilot trial
timeFrame: 12 months
measure: The effect size will be calculated for loneliness
timeFrame: 12 months
measure: The effect size will be calculated for social support
timeFrame: 12 months
measure: The effect size will be calculated for social networks
timeFrame: 12 months
measure: The effect size will be calculated for depression
timeFrame: 12 months
measure: The effect size will be calculated for anxiety
timeFrame: 12 months
measure: The effect size will be calculated for self-efficacy for exercise
timeFrame: 12 months
measure: The effect size will be calculated for satisfaction with level of social contacts
timeFrame: 12 months
measure: The effect size will be calculated for expected outcomes and barriers for exercise
timeFrame: 12 months
Secondary outcomes:
measure: Loneliness
timeFrame: 12 months
measure: Social support
timeFrame: 12 months
measure: Social networks
timeFrame: 12 months
measure: Depression and anxiety
timeFrame: 12 months
measure: Self-efficacy for exercise
timeFrame: 12 months
measure: Satisfaction with level of social contacts
timeFrame: 12 months
measure: Expected outcomes and barriers for exercise
timeFrame: 12 months
measure: Accelerometry
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham
Study officials:
affiliation: University of Birmingham
name: Anna C. Whittaker, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.