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

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-to-vigorous 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 post-intervention 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 usual-care arms.

"Keeping Moving": factors associated with sedentary behaviour among older people recruited to an exercise promotion trial in general practice.

BACKGROUND: Sedentary behaviour is detrimental to health, even in those who achieve recommended levels of physical activity. Efforts to increase physical activity in older people so that they reach beneficial levels have been disappointing. Reducing sedentary behaviour may improve health and be less demanding of older people, but it is not clear how to achieve this. We explored the characteristics of sedentary older people enrolled into an exercise promotion trial to gain insights about those who were sedentary but wanted to increase activity. METHOD: Participants in the ProAct65+ trial (2009-2013) were categorised as sedentary or not using a self-report questionnaire. Demographic data, health status, self-rated function and physical test performance were examined for each group. 1104 participants aged 65 & over were included in the secondary analysis of trial data from older people recruited via general practice. Results were analysed using logistic regression with stepwise backward elimination. RESULTS: Three hundred eighty seven (35 %) of the study sample were characterised as sedentary. The likelihood of being categorised as sedentary increased with an abnormal BMI (<18.5 or >25 g/m(2)) (Odds Ratio 1.740, CI 1.248-2.425), ever smoking (OR 1.420, CI 1.042-1.934) and with every additional medication prescribed (OR 1.069, CI 1.016-1.124). Participants reporting better self-rated physical health (SF-12) were less likely to be sedentary; (OR 0.961, 0.936-0.987). Participants' sedentary behaviour was not associated with gender, age, income, education, falls, functional fitness, quality of life or number of co-morbidities. CONCLUSION: Some sedentary older adults will respond positively to an invitation to join an exercise study. Those who did so in this study had poor self-rated health, abnormal BMI, a history of smoking, and multiple medication use, and are therefore likely to benefit from an exercise intervention. TRIAL REGISTRATION: ISRCTN reference: ISRCTN43453770.

Exercise for reducing fear of falling in older people living in the community.

BACKGROUND: Fear of falling is common in older people and associated with serious physical and psychosocial consequences. Exercise (planned, structured, repetitive and purposive physical activity aimed at improving physical fitness) may reduce fear of falling by improving strength, gait, balance and mood, and reducing the occurrence of falls. OBJECTIVES: To assess the effects (benefits, harms and costs) of exercise interventions for reducing fear of falling in older people living in the community. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2013), the Central Register of Controlled Trials (CENTRAL 2013, Issue 7), MEDLINE (1946 to July Week 3 2013), EMBASE (1980 to 2013 Week 30), CINAHL (1982 to July 2013), PsycINFO (1967 to August 2013), AMED (1985 to August 2013), the World Health Organization International Clinical Trials Registry Platform (accessed 7 August 2013) and Current Controlled Trials (accessed 7 August 2013). We applied no language restrictions. We handsearched reference lists and consulted experts. SELECTION CRITERIA: We included randomised and quasi-randomised trials that recruited community-dwelling people (where the majority were aged 65 and over) and were not restricted to specific medical conditions (e.g. stroke, hip fracture). We included trials that evaluated exercise interventions compared with no intervention or a non-exercise intervention (e.g. social visits), and that measured fear of falling. Exercise interventions were varied; for example, they could be 'prescriptions' or recommendations, group-based or individual, supervised or unsupervised. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently assessed studies for inclusion, assessed the risk of bias in the studies and extracted data. We combined effect sizes across studies using the fixed-effect model, with the random-effect model used where significant statistical heterogeneity was present. We estimated risk ratios (RR) for dichotomous outcomes and incidence rate ratios (IRR) for rate outcomes. We estimated mean differences (MD) where studies used the same continuous measures and standardised mean differences (SMD) where different measures or different formats of the same measure were used. Where possible, we performed various, usually prespecified, sensitivity and subgroup analyses. MAIN RESULTS: We included 30 studies, which evaluated 3D exercise (Tai Chi and yoga), balance training or strength and resistance training. Two of these were cluster-randomised trials, two were cross-over trials and one was quasi-randomised. The studies included a total of 2878 participants with a mean age ranging from 68 to 85 years. Most studies included more women than men, with four studies recruiting women only. Twelve studies recruited participants at increased risk of falls; three of these recruited participants who also had fear of falling.Poor reporting of the allocation methods in the trials made it difficult to assess the risk of selection bias in most studies. All of the studies were at high risk of performance and detection biases as there was no blinding of participants and outcome assessors and the outcomes were self reported. Twelve studies were at high risk of attrition bias. Using GRADE criteria, we judged the quality of evidence to be 'low' for fear of falling immediately post intervention and 'very low' for fear of falling at short or long-term follow-up and all other outcomes.Exercise interventions were associated with a small to moderate reduction in fear of falling immediately post intervention (SMD 0.37 favouring exercise, 95% confidence interval (CI) 0.18 to 0.56; 24 studies; 1692 participants, low quality evidence). Pooled effect sizes did not differ significantly between the different scales used to measure fear of falling. Although none of the sensitivity analyses changed the direction of effect, the greatest reduction in the size of the effect was on removal of an extreme outlier study with 73 participants (SMD 0.24 favouring exercise, 95% CI 0.12 to 0.36). None of our subgroup analyses provided robust evidence of differences in effect in terms of either the study primary aim (reduction of fear of falling or other aim), the study population (recruitment on the basis of increased falls risk or not), the characteristics of the study exercise intervention or the study control intervention (no treatment or alternative intervention). However, there was some weak evidence of a smaller effect, which included no reduction, of exercise when compared with an alternative control.There was very low quality evidence that exercise interventions may be associated with a small reduction in fear of falling up to six months post intervention (SMD 0.17, 95% CI -0.05 to 0.38; four studies, 356 participants) and more than six months post intervention (SMD 0.20, 95% CI -0.01 to 0.41; three studies, 386 participants).Very low quality evidence suggests exercise interventions in these studies that also reported on fear of falling reduced the risk of falling measured either as participants incurring at least one fall during follow-up or the number of falls during follow-up. Very low quality evidence from four studies indicated that exercise interventions did not appear to reduce symptoms of depression or increase physical activity. The only study reporting the effects of exercise interventions on anxiety found no difference between groups. No studies reported the effects of exercise interventions on activity avoidance or costs. It is important to remember that our included studies do not represent the totality of the evidence of the effect of exercise interventions on falls, depression, anxiety or physical activity as our review only includes studies that reported fear of falling. AUTHORS' CONCLUSIONS: Exercise interventions in community-dwelling older people probably reduce fear of falling to a limited extent immediately after the intervention, without increasing the risk or frequency of falls. There is insufficient evidence to determine whether exercise interventions reduce fear of falling beyond the end of the intervention or their effect on other outcomes. Although further evidence from well-designed randomised trials is required, priority should be given to establishing a core set of outcomes that includes fear of falling for all trials examining the effects of exercise interventions in older people living in the community.

Multicentre cluster randomised trial comparing a community group exercise programme and home-based exercise with usual care for people aged 65 years and over in primary care.

BACKGROUND: Regular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements. OBJECTIVE: To evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years. DESIGN: The ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥ 65 years) in primary care. SETTING: Forty-three UK-based general practices in London and Nottingham/Derby. PARTICIPANTS: A total of 1256 people ≥ 65 years were recruited through their general practices to take part in the trial. INTERVENTIONS: The FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking. MAIN OUTCOME MEASURES: The primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial. RESULTS: In total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants. The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87; p = 0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92; p = 0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99; p = 0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93). CONCLUSION: The FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms. TRIAL REGISTRATION: This trial is registered as ISRCTN43453770. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website for further project information.

Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial.

BACKGROUND: Failure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses, and inaccurate capture of risks to participants can influence reporting of intervention harms and benefits.In this paper we describe how challenges of recruitment and retention of participants, standardisation and quality control of interventions and capture of adverse events were overcome in the ProAct65+ cluster RCT. This trial compared class-based and home-based exercise with usual care in people aged 65 years and over, recruited through general practice. The home-based exercise participants were supported by Peer Mentors. RESULTS: (1) Organisational factors, including room availability in general practices, slowed participant recruitment so the recruitment period was extended and the number invited to participate increased. (2) Telephone pre-screening was introduced to exclude potential participants who were already very active and those who were frequent fallers. (3) Recruitment of volunteer peer mentors was difficult and time consuming and their acceptable case load less than expected. Lowering the age limit for peer mentors and reducing their contact schedule with participants did not improve recruitment. (4) Fidelity to the group intervention was optimised by introducing quality assurance observation of classes by experienced exercise instructors. (5) Diaries were used to capture data on falls, service use and other exercise-related costs, but completion was variable so their frequency was reduced. (6) Classification of adverse events differed between research sites so all events were assessed by both sites and discrepancies discussed. CONCLUSIONS: Recruitment rates for trials in general practice may be limited by organisational factors and longer recruitment periods should be allowed for. Exercise studies may be attractive to those who least need them; additional screening measures can be employed to avoid assessment of ineligible participants. Enrolment of peer mentors for intervention support is challenging and needs to be separately tested for feasibility. Standardisation of exercise interventions is problematic when exercise programmes are tailored to participants' capabilities; quality assurance observations may assure fidelity of the intervention. Data collection by diaries can be burdensome to participants, resulting in variable and incomplete data capture; compromises in completion frequency may reduce missing data. Risk assessments are essential in exercise promotion studies, but categorisation of risks can vary between assessors; methods for their standardisation can be developed. TRIAL REGISTRATION: ISRCTN43453770.

A talking control for use in evaluating the effectiveness of cognitive-behavioral therapy.

OBJECTIVE: Common factors predict outcome in psychotherapy, but there is a dearth of research defining and standardising control conditions. A description and evaluation of a talking control (TC) used in a randomized controlled trial (RCT) of cognitive-behavioral therapy (CBT) for older people with depression in primary care is presented. METHODS: Two hundred and four older people participated in a RCT of CBT for people with a Geriatric Mental State diagnosis of Depression (Serfaty et al., 2009). One in 10 session of CBT or TC were evaluated using the Cognitive Therapy Scale (CTS) to examine common and specific factors in therapy. RESULTS: 1005 therapy sessions were delivered; 508 for TC and 497 CBT. There were higher total CTS scores (P<0.001) for CBT (median 55.0; QR 52.0-55.0) than TC (median 23.0; QR 21.0-24.0). CBT scored better than TC for specific techniques (median 23.7; IQR 21.0-24.0 versus median 0.70.0; IQR 0.0-0.0, P<0.001). Both interventions scored highly for interpersonal effectiveness, but no difference was observed. The TC was easily delivered, deemed acceptable by patients and was not associated with harm. CONCLUSIONS: Development, standardization and measurement of a TC intervention is possible and provides a useful comparator in evaluations of effectiveness of CBT.

Clinical effectiveness of individual cognitive behavioral therapy for depressed older people in primary care: a randomized controlled trial.

CONTEXT: In older people, depressive symptoms are common, psychological adjustment to aging is complex, and associated chronic physical illness limits the use of antidepressants. Despite this, older people are rarely offered psychological interventions, and only 3 randomized controlled trials of individual cognitive behavioral therapy (CBT) in a primary care setting have been published. OBJECTIVE: To determine the clinical effectiveness of CBT delivered in primary care for older people with depression. DESIGN: A single-blind, randomized, controlled trial with 4- and 10-month follow-up visits. PATIENTS: A total of 204 people aged 65 years or older (mean [SD] age, 74.1 [7.0] years; 79.4% female; 20.6% male) with a Geriatric Mental State diagnosis of depression were recruited from primary care. INTERVENTIONS: Treatment as usual (TAU), TAU plus a talking control (TC), or TAU plus CBT. The TC and CBT were offered over 4 months. OUTCOME MEASURES: Beck Depression Inventory-II (BDI-II) scores collected at baseline, end of therapy (4 months), and 10 months after the baseline visit. Subsidiary measures were the Beck Anxiety Inventory, Social Functioning Questionnaire, and Euroqol. Intent to treat using Generalized Estimating Equation and Compliance Average Causal Effect analyses were used. RESULTS: Eighty percent of participants were followed up. The mean number of sessions of TC or CBT was just greater than 7. Intent-to-treat analysis found improvements of -3.07 (95% confidence interval [CI], -5.73 to -0.42) and -3.65 (95% CI, -6.18 to -1.12) in BDI-II scores in favor of CBT vs TAU and TC, respectively. Compliance Average Causal Effect analysis compared CBT with TC. A significant benefit of CBT of 0.4 points (95% CI, 0.01 to 0.72) on the BDI-II per therapy session was observed. The cognitive therapy scale showed no difference for nonspecific, but significant differences for specific factors in therapy. Ratings for CBT were high (mean [SD], 54.2 [4.1]). CONCLUSION: Cognitive behavioral therapy is an effective treatment for older people with depressive disorder and appears to be associated with its specific effects. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18271323.

Obstacles to shared care for patients with dementia: a qualitative study.

BACKGROUND: All Primary Care Trusts in England were meant to have shared care protocols for antidementia medication use in place by 1 April 2004. Shared care of medical treatment in dementia depends upon early diagnosis, but under-recognition of and under-response to dementia appear widespread in general practice. AIM: To investigate the perceptions of specialists and generalists about the potential for shared care of people with dementia. DESIGN OF STUDY: Qualitative study with semistructured interviews. SETTING: Three inner-city and two rural areas. METHODS: Semistructured interviews were arranged at the participants' convenience and were tape-recorded and transcribed. Thematic analysis of the anonymized transcripts was undertaken and a case and cross-case analysis was performed. RESULTS: Thirty-nine GPs and 30 specialists were interviewed. Broad themes were reduced to following four key categories which appear to be layered over each other: therapeutic nihilism; risk reduction or avoidance; concerns about competency; and resources for shared care. CONCLUSION: Roles for primary and secondary care professionals are inappropriately distributed and require clearer definition. Resistance to shared care mostly comes from within general practice and reflects concerns about staffing, time constraints, lack of experience and confidence in making and disclosing a diagnosis. Developers of shared care protocols must dissect layered obstacles, addressing the issues of therapeutic nihilism, risk management and clinical competence.

The feasibility and acceptability of a specialist health and social care team for the promotion of health and independence in 'at risk' older adults.

Population ageing, escalating costs in pensions, health-care and long-term care have prompted a new policy agenda for active ageing and quality of life in old age across the European Union and other developed countries. In England, the National Service Framework for Older People (NSF OP) explicitly demands for the first time that the NHS and local authorities, in partnership, agree programmes to promote health ageing and to prevent disease in older people. These programmes are expected to improve access for older people to mainstream health promotion services and also to develop multiagency initiatives to promote health, independence and well-being in old age. This paper describes the evaluation of one interagency project team established to test out mechanisms for addressing health promotion for older people through primary care. A mixed methodology was used to understand the processes of service development, the impact of the team's intervention, and the primary and secondary outcomes for older people. The project demonstrated that multi-agency partnerships have the potential to improve the quality of the lives of older people deemed 'at risk' by their general practitioners, particularly through income generation but also in the identification of medical problems such as unrecognised hypertension, hearing loss and visual loss. It also offered some key learning points for other multi-agency groups developing similar services.

Older people's services. A picture of health.

A scheme offering joint health and social care assessments to people aged over 75 in inner London identified more than a quarter in need of services. The older people were accessed via general practice, but this proved an inefficient way of identifying the target population. In some practices, almost half of those contacted were no longer at the same address. The assessments, conducted by a community nurse and social welfare officer, often involved two visits. The mobility of the elderly population needs to be taken into account when planning joint assessments. Organisations involved had different aspirations for the scheme and management proved problematic.