Dataset Information

Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial.

ABSTRACT:

Introduction

Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.

Methods and analysis

A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ?10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.

Ethics and dissemination

Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.

Trial registration number

ISRCTN15644451; Pre-results.

SUBMITTER: Ingram W

PROVIDER: S-EPMC6157530 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Publications

Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial.

Ingram Wendy W Webb Douglas D Taylor Rod S RS Anokye Nana N Yardley Lucy L Jolly Kate K Mutrie Nanette N Campbell John L JL Dean Sarah Gerard SG Greaves Colin C Steele Mary M Lambert Jeffrey D JD McAdam Chloe C Jane Ben B King Jennie J Jones Ray B RB Little Paul P Woolf Anthony A Erwin Jo J Charles Nigel N Terry Rohini H RH Taylor Adrian H AH

BMJ open 20180921 9

<h4>Introduction</h4>Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This st ...[more]

PMID: 30244214

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Project description:BackgroundExercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services.ObjectiveTo determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial.MethodsWe conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2.ResultsParticipants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future.ConclusionsTo our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met.Trial registrationISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652.

Project description:Exercise referral schemes (ERS) are used to promote physical activity within primary care. Traditionally, ERS are conducted in a gym or leisure-center setting, with exercise prescriptions based on moderate-intensity continuous training (MICT). Home-based high-intensity interval training (Home-HIIT) has the potential to reduce perceived barriers to exercise, including lack of time and access to facilities, compared to traditional MICT prescription used with ERS and improve health related outcomes. We hypothesized that Home-HIIT would mediate greater improvement in cardiorespiratory fitness (CRF) by virtue of greater adherence and compliance to the exercise prescription, compared to MICT. Methods: Patients enrolled on an ERS (Liverpool, United Kingdom) were recruited for a pragmatic trial. Participants self-selected either 12 weeks of MICT (45-135 min/week at 50-70% HRmax) or Home-HIIT (4-9 min × 1 min intervals at ≥80% of HRmax, interspersed with 1 min rest). The primary outcome was the change in CRF (VO2 peak) at post-intervention (12 weeks) and follow-up (3-month post intervention), using intention-to-treat analysis. Results: 154 participants (age 48 ± 10y; BMI 30.5 ± 6.1 kg/m2) were recruited between October 2017 and March 2019, 87 (56%) participants chose Home-HIIT and 67 (44%) MICT. VO2 peak increased post-intervention in both groups (MICT 3.9 ± 6.0 ml.kg-1.min-1, Home-HIIT 2.8 ± 4.5 ml.kg-1.min-1, P < 0.001), and was maintained at follow-up (P < 0.001). Fat mass was only reduced post MICT (MICT -1.5 ± 6.3 kg, P < 0.05, Home-HIIT -0.2 ± 2.0 kg, P = 1.00), but the reduction was not maintained at follow-up (MICT -0.6 ± 5.1 kg, Home-HIIT 0.0 ± 2.2 kg, P > 0.05). Adherence to the prescribed programs was similar (MICT 48 ± 35%, Home-HIIT 39 ± 36%, P = 0.77). Conclusion: This is the first study to evaluate the use of Home-HIIT for individuals in a primary care setting. Contrary to our hypothesis, adherence to both exercise prescriptions was poor, and CRF improved to a similar extent in both groups with improvements maintained at 3-month follow-up. We provide evidence that, although not superior, Home-HIIT could be an effective and popular additional exercise choice for patients within primary care based ERS. Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT04553614].

Project description:BACKGROUND: Although the benefits of physical activity (PA) on to prevent and manage non-communicable diseases are well known, strategies to help increase the levels of PA among different populations are limited. Exercise-referral schemes have emerged as one effective approach to promote PA; however, there is uncertainty about the feasibility and effectiveness of these schemes in settings outside high-income countries. This study will examine the effectiveness of a scheme to refer hypertensive patients identified in Primary Health Care facilities (PHCU) of the Mexican social security institution to a group PA program offered in the same institution. METHODS AND DESIGN: We will describe the methods of a cluster randomized trial study designed to evaluate the effectiveness of an exercise referral scheme to increasing physical activity in hypertensive patients compared to a non-referral scheme. Four PHCU were selected for the study; the PHCU will take part as the unit of randomization and sedentary hypertensive patients as the unit of assessment. 2 PHCU of control group (GC) will provide information to hypertensive patients about physical activity benefits and ways to increase it safely. 2 PHCU of intervention group (IG) will refer patients to sports facilities at the same institution, to follow a group-based PA program developed to increase the PA levels with a designed based on the Transtheoretical Model and Social Cognitive Theory. To evaluate the effects of the intervention as well as short-term maintenance of the intervention's effects, PA will be assessed at baseline, at 24 and 32 weeks of follow-up.The main outcome will be the difference before and after intervention in the percentage of participants meeting recommended levels of PA between and within intervention and control groups. PA will be measured through self-report and with objective measure by accelerometer. DISCUSSION: This study will allow us to evaluate a multidisciplinary effort to link the primary care and community-based areas of the same health care system. Our findings will provide important information about the feasibility and effectiveness of an exercise-referral scheme and will be useful for decision-making about the implementation of strategies for increasing PA among hypertensive and other clinical populations in Mexico and Latin America. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01910935. Date of registration: 07/05/2013.

Dataset Information

Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial.

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