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Physical Activity Intervention for Loneliness (PAIL)

17 de abril de 2019 atualizado por: Anna Whittaker, University of Birmingham

Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study

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).

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

25

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Birmingham, Reino Unido, B15 2TT
        • School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

60 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: The experimental group
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.

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

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Attendance
Prazo: 12 months
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
Prazo: 12 months
Percent of subjects responding to ads and friends' referrals out of total number of invitations given out as a percentage
12 months
Retention rate
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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
Prazo: 12 months
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Loneliness
Prazo: 12 months
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.
12 months
Social support
Prazo: 12 months
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.
12 months
Social networks
Prazo: 12 months
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.
12 months
Depression and anxiety
Prazo: 12 months
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.
12 months
Self-efficacy for exercise
Prazo: 12 months
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.
12 months
Satisfaction with level of social contacts
Prazo: 12 months
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).
12 months
Expected outcomes and barriers for exercise
Prazo: 12 months
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).
12 months
Accelerometry
Prazo: 12 months
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.
12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Anna C. Whittaker, Professor, University of Birmingham

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de janeiro de 2018

Conclusão Primária (Real)

28 de dezembro de 2018

Conclusão do estudo (Real)

29 de dezembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

23 de janeiro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de março de 2018

Primeira postagem (Real)

8 de março de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de abril de 2019

Última verificação

1 de abril de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • ERN_16-1419

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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