Physical Activity Intervention for Loneliness (PAIL)

University of Birmingham

Status: Completed

Conditions: Physical Activity; Loneliness; Ageing

Treatments: Behavioral: Group walking and group educational workshops

Study type: Interventional

Funder types: Other

Identifiers

NCT03458793

ERN_16-1419

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

The experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: Group walking and group educational workshops

The control group

No Intervention group

Description:

The control group will be a wait-listed arm that will be offered an intervention at 12 weeks after the randomisation (the delayed intervention).