Physical Activity Intervention for Loneliness

NCT03458793 | Completed

• 1 other identifier: ERN_16-1419
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Loneliness; Ageing; Physical Activity

Keywords

randomised controlled study; physical activity; loneliness

Outcome Measures

Primary Outcomes (16)

• 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.

  12 months

• Recruitment rate

  Percent of subjects responding to ads and friends' referrals out of total number of invitations given out as a percentage

  12 months

• Retention rate

  Number of participants completing the study as a proportion of those randomised

  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

  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

  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

  12 months

• The appropriateness of statistical methods of data analysis

  The appropriateness of statistical methods of data analysis will be analysed by research team

  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

  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

  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

  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

  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

  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

  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

  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

  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

  12 months

Secondary Outcomes (8)

• Loneliness

  12 months

• Social support

  12 months

• Social networks

  12 months

• Depression and anxiety

  12 months

• Self-efficacy for exercise

  12 months

Study Arms (2)

The experimental group

EXPERIMENTAL

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

NO INTERVENTION

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

Interventions

Group walking and group educational workshops BEHAVIORAL

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

The experimental group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community-dwelling older adults aged 60 years and older as defined according to the United Nations standard numerical criterion (World Health Organization, 2016);
• 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);
• 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);
• 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);
• healthy or having one or more common chronic diseases but ambulatory;
• 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);
• able to give written informed consent;
• English speaking and able to complete paper and pencil questionnaires.

You may not qualify if:

• not community-dwelling older adults 60 years or over;
• not previously sedentary;
• currently taking part in another physical activity intervention;
• 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);
• moderate to severe cognitive disability or clinical diagnosis of dementia;
• physical disability (i.e. SPPB score less than 9);
• 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);
• cognitive disability (i.e. less than 14 points on MOCA);
• not able to give written informed consent;
• not English speaking that precludes taking pen and paper tests.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32489675 DERIVED

• 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.

  PMID: 30598833 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anna C. Whittaker, Professor

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computerised randomisation will be performed by an external researcher not involved in the delivery of the intervention or outcome assessment. Participants who will be assessors of their psychosocial outcomes using self-report questionnaires will be blind to the allocation concealment at the time of completing the initial questionnaires. Intervention providers who will be responsible for outcome assessments will not be blind to the intervention assignment as this would not be possible given the study and walks will be conducted by the PhD student.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This will be a two-arm randomised controlled trial (RCT) with a wait-list control group

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 8, 2018
• Study Start: January 4, 2018
• Primary Completion: December 28, 2018
• Study Completion: December 29, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)