Promoting physical activity in older people in general practice:

Research Steve Iliffe, Denise Kendrick, Richard Morris, Mark Griffin, Deborah Haworth, Hannah Carpenter, Tahir Masud, Dawn A Skelton, Susie Dinan-Young, Ann Bowling and Heather Gage on behalf of the ProAct65+ research team

Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial Abstract Background

Regular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups.

Aim

To evaluate two exercise programmes promoting physical activity among older people.

Design and setting

Pragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby.

Method

Practices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs.

Results

In total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-tovigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar.

Conclusion

The FaME programme increases self-reported physical activity for at least 12 months postintervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usualcare arms.

Keywords

aged people; exercise promotion; falls; general practice; physical activity.

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INTRODUCTION Physical activity reduces the risk of cardiovascular disease, type 2 diabetes, osteoporosis, falls, hip fractures, certain cancers, and all-cause mortality.1–3 Promoting physical activity in older people could prevent functional decline, frailty, falls, and fractures.4 Current physical activity recommendations are 150 minutes of moderate-to-vigorous physical activity (MVPA) per week,5 including activities that challenge balance. However, physical inactivity is widespread6 and the most effective ways of increasing and maintaining physical activity remain unclear. This article reports the findings from a trial of exercise programmes for older people on achievement and maintenance of recommended physical activity targets.

Eligibility Practices were recruited with assistance from Primary Care Research Networks for London, Derby, and Nottingham. Patients aged ≥65 years were identified by searches of computerised medical records and invited to participate by letter from their GP. Patients were eligible to participate if they were:

METHOD The full trial protocol is reported elsewhere,7 as are changes to the protocol introduced during the trial.8 Full details of the trial design, recruitment, analysis, and reporting of findings (including a CONSORT statement) are available from the Health Technology Assessment (HTA) report of the study.9 A three-arm, parallel-design cluster controlled trial was used, with allocation at the level of general practice in two centres (London and Nottingham/Derby).

• had unstable clinical conditions;

S Iliffe, BSc, FRCGP, professor of primary care for older people; M Griffin, MSc, statistician; D Haworth, MA, MSc, trial manager; S Dinan-Young, PhD, exercise advisor, University College London, London. R Morris, PhD, professor of medical statistics, University of Bristol, Bristol. D Kendrick, MSc (Med Stat), DM, FRCGP, MFPH, professor of primary care; H Carpenter, MSc, trial manager, University of Nottingham, Nottingham. T Masud, MBBS, PhD, professor of geriatric medicine, Nottingham University Hospitals NHS Trust, Nottingham. D Skelton, PhD, professor, School of Health and Life Sciences, Glasgow Caledonian University, Glasgow. A Bowling, PhD, professor of medical sociology, University

• community dwelling aged ≥65 years; • independently mobile (with or without a walking aid); and • physically able to take part in group exercise. Patients were excluded if they: • had experienced ≥3 falls in the previous year; • would be unable to follow instructions about exercise safely; or • were receiving palliative care. Attempts were made to exclude those who were already exercising at, or above, the target level through a pre-assessment screening telephone call. Interventions The interventions were the home-based of Southampton. H Gage, PhD, reader in health economics, University of Surrey, Guildford. Address for correspondence Steve Iliffe, Research Department of Primary Care and Population Health, UCL, Royal Free campus, Rowland Hill St, London NW3 2PF, UK. E-mail: [email protected] Submitted: 11 February 2015; Editor’s response: 20 April 2015; final acceptance: 5 June 2015. ©British Journal of General Practice This is the full-length article (published online 26 Oct 2015) of an abridged version published in print. Cite this article as: Br J Gen Pract 2015; DOI: 10.3399/bjgp15X687361

How this fits in Physical activity protects against disablement and a range of diseases in later life, but the older population is largely inactive. The most effective ways to increase and maintain physical activity levels in older people over prolonged periods are unclear. A class-based exercise programme added, on average, around 15 minutes of moderate-to-vigorous physical activity per day in older people and class participants experienced significantly fewer falls, but uptake of exercise promotion was low.

• positive and negative outcomes expectations for exercise (Outcome Expectations for Exercise scale [OEE]); • quality of life (Older People’s Quality of Life Questionnaire [OPQOL], EQ-5D, and 12-item Short Form Health Survey [SF12]); • social network size and density (brief Lubben Social Network Scale); • perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS]); • falls risk (Falls Risk Assessment Tool [FRAT]); • Timed Up and Go;

Otago Exercise Programme (OEP),10 and a group-based exercise programme called Falls Management Exercise (FaME).11 The FaME intervention took place in a group once a week and included exercises to be carried out at home, unsupervised, twice weekly. The OEP was undertaken at home, unsupervised, and comprised exercises to be done three times per week. The programmes included the following progression: • OEP — ankle weights and hand holds; and • FaME — resistance bands and hand holds, plus a move to more dynamic balance work and floor work with postural stability instructors. Volunteer peer mentors supported participants in the OEP arm, and weekly FaME classes were run in local venues by postural stability instructors trained to work with older people. Both interventions were delivered for 24 weeks. Participants in the usual-care arm were not offered either programme. Outcomes and outcome measures The primary outcome was the proportion of participants who reported reaching ≥150 minutes of MVPA per week. Physical activity was assessed using three validated questionnaires: Phone-FITT, the Physical Activity Scale for the Elderly (PASE), and the Community Healthy Activities Model Program for Seniors (CHAMPS). The primary outcome measure was the CHAMPS questionnaire. Secondary outcomes are described in full in the trial protocol7 but included: • balance confidence (CONFbal scale); • falls efficacy (Falls Efficacy ScaleInternational [FES-I]);

• forward reach; and • the 30-second chair stand. Demographic information, comorbidities, and medication were recorded at baseline; use of general practice and hospital and community social services was recorded at follow-up assessments. Falls were ascertained from diaries returned by participants every 4 weeks during the intervention and every 3 months in the subsequent year, and from reports given in follow-up telephone interviews using the Phone-FITT questionnaire. The NHS costs of delivering each exercise programme were captured from study records and included staff, facilities, equipment, and overheads. Participants were followed up every 6 months after the end of the intervention period, until 24 months. The primary time point was chosen as 12 months postintervention to match other trials.7 Sample size Sample size estimates were based on detecting differences between each intervention and the control arm in proportions of participants reaching ≥150 minutes of MVPA per week using 90% power, a two-sided 5% significance level, an intra-cluster correlation coefficient of 0.01, 30% attrition, a mean cluster size post-attrition of 32, and the percentage achieving physical activity target of 14.6% in the intervention arms and 4.9% in the control arm.12 Randomisation Minimisation using site, practice size, and deprivation was used to allocate practices to treatment arms,13 once all participants from a practice were recruited. Full details are available in the trial report.7 Blinding General practices, participants, and researchers having contact with practices

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and participants were blind to the treatment arm until all participants within a practice were recruited. Analyses were undertaken without researchers being blind to the treatment arm allocation. To minimise bias an a priori statistical analysis plan with the trial steering committee was agreed.

Figure 1. Trial progress of practices and participants. FaME = Falls Management Exercise. OEP = Otago Exercise Programme. Research burden is the judgement by participants that research activities (completion of diaries and questionnaires) are burdensome to them.

Statistical methods Participants were analysed in the groups to which they were randomised, regardless of whether they received the intervention or not, and multiple imputation was used to include all participants in the analyses. Baseline characteristics were compared informally between treatment arms. Comparisons between treatment arms were made using random-effects regression models to allow for clustering between practices. Linear models were used for continuous outcome variables, logistic models for binary outcome variables, and negative binomial models for data on rate of falls. The CHAMPS score measuring minutes of physical activity followed a lognormal distribution with many zeros, and was therefore transformed to log e(CHAMPSscore+1). The proportions of participants whose weekly MVPA exceeded 150 minutes, and those who reported zero MVPA, were tabulated for all time points. All analyses were undertaken adjusted for minimisation variables and for baseline outcome measure values. Differential effects of the intervention

Practices enrolled, n = 43 London practices, n = 22

Nottingham/Derby practices, n = 21

Randomisation

Randomisation

OEP practices, n=8

FaME practices, n=7

Usual care, n=7

OEP practices, n=6

FaME practices, n=7

Usual care, n=7

OEP participants at baseline, n = 410

FaME participants at baseline, n = 387

Usual-care participants at baseline, n = 457

Lost to follow-up at 12 months, n = 158 (at allocation n = 27, GP excluded n = 13, died n = 3, illness n = 43, research burden n = 15, other reasons n = 17, not known n = 40)



Remaining in trial at primary endpoint, n = 252



Primary outcome data available, n = 185



Available for complete case study analysis, n = 178



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by age (>/