Dataset Information

Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults.

ABSTRACT: INTRODUCTION:The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE). METHODS AND ANALYSIS:The PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6?months intervention period and at 1?year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm). ETHICS AND DISSEMINATION:Ethical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published. TRIAL REGISTRATION NUMBER:NCT03065088; Pre-results.

SUBMITTER: Taraldsen K

PROVIDER: S-EPMC6527989 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults.

Taraldsen Kristin K Mikolaizak A Stefanie AS Maier Andrea B AB Boulton Elisabeth E Aminian Kamiar K van Ancum Jeanine J Bandinelli Stefania S Becker Clemens C Bergquist Ronny R Chiari Lorenzo L Clemson Lindy L French David P DP Gannon Brenda B Hawley-Hague Helen H Jonkman Nini H NH Mellone Sabato S Paraschiv-Ionescu Anisoara A Pijnappels Mirjam M Schwenk Michael M Todd Chris C Yang Fan Bella FB Zacchi Anna A Helbostad Jorunn L JL Vereijken Beatrix B

BMJ open 20190320 3

<h4>Introduction</h4>The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smart ...[more]

PMID: 30898801

Similar Datasets

Project description:Older adults with Hematologic Malignancy (HM) are vulnerable to functional decline secondary to disease and treatment. Interventions for physical deconditioning, in concert with routine hematology care are limited. The feasibility of accrual, retention, and demand for an exercise intervention among a high-risk HM population was piloted.MethodsOlder adults with HM, on active treatment, with functional impairment were recruited prospectively to participate in a 6-month Otago Exercise Programme (OEP). Measures of motivation, self-efficacy, patient identified barriers to exercise, barriers to clinical trial enrollment, study satisfaction, and serious adverse events were captured.Results63 patients were approached, 18 declined trial enrollment, 45 consented, 30 patients enrolled in the exercise program. The main barrier for trial enrollment was transportation/travel concerns (n = 15). Of the 45 consented participants, 8 (12.7%) dropped out due to clinical deterioration, 5 (7.9%) withdrew, and 2 (3.2%) were ineligible prior to exercise-intervention intiation. The median age was 75.5 years (range 62-83) with plasma cell dyscrasia (63%), non-Hodgkin lymphoma (20%) and leukemia (17%). Retention of the physical therapist (PT) led-OEP was 76.6% of patients (n = 23/30), and end-of-study retention was 66.7% (n = 20/30). Of the evaluable patients, 23/29 completed the PE-led OEP yielding a completion rate of 79%. Participants were extremely motivated (72.4%) and strongly intended (89.7%) to engage in regular physical activity. Exercising when tired increased from a median score of 50 at Visit 1 to 70 at Visit 2, but dropped significantly to 45 at Visit 3 (p < 0.001). Participants reported significantly lower self-efficacy to exercise over the next 6 months from Visit 1 to Visit 3 (p = 0.001).ConclusionsOlder patients with HM had higher completion of in-person, PT-led exercise compared to at-home, independent exercise. Older adults were motivated and found the program acceptable, yet the ability to sustain a structured exercise program was challenging due to changes in health status. ClinicalTrials.gov Identifier: NCT02791737.

Project description:BackgroundThe number of incident cases and deaths from primary liver cancer, predominantly hepatocellular carcinoma (HCC), has increased markedly in the last two decades. HCC is generally diagnosed at an advanced stage, and most new cases are in people aged over 70 years with age-related comorbidities. Treatment options are often limited, with most patients receiving palliative treatment or supportive care only. As a consequence, maintaining quality of life (QoL) through symptom management is critically important and is a core objective of clinical care. Strong evidence supports the efficacy of supervised exercise training for addressing certain cancer-related symptoms, including QoL, physical function, and fatigue. However, there are many barriers to implementing supervised exercise programmes within cancer care pathways, including economic pressures on healthcare systems and personal barriers for patients. Recent advances in technology allow patients to exercise at home under the 'virtual' supervision of an exercise professional through videoconferencing software (termed 'telehealth exercise'). Despite its potential, there are uncertainties relating to the feasibility, acceptability, and safety of telehealth exercise in people living with HCC.MethodsThis is a protocol for a prospective, single-centre, single-arm, pretest-posttest feasibility trial. We aim to recruit 20 patients aged 60 years or older who have received treatment for HCC and are undergoing routine clinical monitoring. Patients will be invited to take part in two online, home-based, group exercise sessions per week for 10 consecutive weeks. The 'virtual' exercise sessions will be delivered in real time by an exercise professional through videoconferencing software. Each session will comprise 30 min of aerobic and resistance exercise performed at a moderate intensity, as guided by the 10-point Borg rating of perceived exertion scale. Feasibility outcomes include recruitment, retention, adherence, intervention fidelity, and safety. Acceptability of the intervention will be assessed using a mixed-methods approach via monthly online surveys and an exit telephone interview. Physical function, accelerometry-measured physical activity, mid-upper arm circumference, and patient-reported outcome measures (PROMS) will be assessed before and after the intervention to determine the feasibility of assessing outcome measures. Physical function outcomes include the short physical performance battery and Liver Frailty Index. PROMS include the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire, Activities-specific Balance Confidence scale, Hospital Anxiety and Depression Scale, and the Godin Leisure-Time Exercise Questionnaire.DiscussionThis mixed-methods study will address uncertainties relating to the feasibility and acceptability of delivering live, online, home-based, group exercise sessions to patients with HCC. The findings will inform whether any modifications are required to refine and optimise the intervention, and the assessment of outcome measures will provide information on the likely size and variability of intervention effects. Collectively, the data generated will inform the design of a subsequent, adequately powered, randomised controlled trial to evaluate the efficacy of the telehealth exercise intervention.Trial registrationISRCTN14411809.

Project description:BackgroundLow quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other health benefits. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness.MethodsThe PAIL feasibility study was a 12-week randomized controlled feasibility trial (RCT) conducted in Birmingham, United Kingdom, from February 2018 to August 2018, and ran in two waves of data collection. Eligible participants were community-dwelling adults aged 60 years and older, sedentary (less than 20 min of moderate-to-vigorous PA (MVPA) a week), and at risk of loneliness. The intervention included once-weekly group walk and health education workshop up to 90 min per session in total, with a wait-listed (WL) control group. The primary feasibility outcomes were to estimate recruitment, retention rates and adherence to the intervention. Secondary outcome measures (not blinded assessment) were body mass index, blood pressure, physical activity and psychosocial variables. Process and outcome evaluations were conducted using focus groups interviews. The recruitment and retention progression criteria for the definitive large-scale RCT was set a-priori.ResultsForty-eight participants were recruited over 4 months with a recruitment rate of 25% (48/195); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomised into the intervention (n = 12) and WL control groups (n = 13). Participants were 25 older adults (mean (SD) 68.5(8.05) years), 14 (56%) female, and 18 (72%) white. At 12 weeks, 10/12 (83.3%) intervention and 10/13 (76.9%) control participants completed the final assessments. The average attendance rate was 58.3% for the intervention group (range 33.0%-75.0%) and 42.3% (range 23.1%-69.2%) among controls. The a priori recruitment and retention criteria for progression were not met. No serious adverse events occurred. The focus group results identified three themes which showed overall positive experiences of participation in PAIL in terms of (1) study design and intervention; (2) walking sessions; and (3) health education workshops.ConclusionsThe findings suggest that community-dwelling older adults at risk of loneliness found the intervention and measures acceptable and could safely participate. However, a more extensive and robust strategy would be needed to support adequate recruitment of lonely older adults and adherence into a definitive RCT.Trial registrationClinicaltrials.gov, NCT03458793.

Project description:BackgroundHigh-quality evidence supports the integration of exercise to mitigate treatment-related side effects in a wide range of paediatric and adult cancer cohorts. However, the implementation of exercise in adolescent and young adult (AYA) cancer patients is yet to be explored in depth. FiGHTINGF!T is a randomised controlled cross over trial designed to determine if a supervised, structured, and progressive exercise programme can reduce the decline in physical fitness (V02peak) associated with cancer treatment in AYAs from diagnosis.Methods/designA total of 40 AYAs recently diagnosed and due to commence systemic treatment (± 2 weeks) for a primary haematological malignancy or solid tumour will be recruited and randomised to either an immediate exercise intervention or usual care (delayed exercise) for 10 weeks. This randomised controlled crossover trial will see both groups engage in a supervised exercise intervention from either diagnosis (baseline assessment) for 10 weeks (0-10 weeks) or following an interim assessment to 20 weeks (10-20 weeks). The bi-weekly tailored exercise programme will combine aerobic and resistance exercises and be supervised by an Accredited Exercise Physiologist. Participants will complete a range of assessments at 0, 10, and 20 weeks including cardiopulmonary exercise tests, 1 repetition maximum strength measures, physical functioning, and self-reported quality of life measurements. Patient-reported treatment-related toxicities will be recorded on a weekly basis.DiscussionThe FiGHTINGF!T trial will provide insight into the potential benefits of a supervised exercise programme in AYAs undergoing cancer treatment. This trial will contribute to the evidence supporting the necessary integration of exercise during cancer treatment, specifically in the under-reported AYA cohort.Trial registrationThis trial was registered retrospectively with the Australia New Zealand Clinical Trial registry ( ACTRN12620000663954 ). Registered on 10 June 2020.

Dataset Information

Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults.

Publications

Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets