The feasibility and preliminary effectiveness of exercise therapy in transdiagnostic mental health services.
The University of Western Australia
50 participants
Apr 29, 2024
Interventional
Conditions
Summary
Individuals living with a severe mental illness experience a significantly reduced life expectancy when compared to the general population, attributable in part to increased rates of cardiovascular diseases and metabolic syndromes that are associated with psychotropic medication use and poor health behaviours (e.g., low physical activity levels, poor diet quality and high sedentary time). There is a concerted effort to preserve (and improve) the physical health of individuals living with mental illness, with exercise increasingly advocated as part of mental health care due to the positive effect exercise has on physical and psychological health. One of the challenges for exercise services is to provide best practice exercise therapy, and support consumers to establish and maintain positive health behaviours in a client-centred and efficient manner. This trial will implement an effectiveness-implementation hybrid design to determine the feasibility and effectiveness of supported exercise therapy within transdiagnostic tertiary mental health care services. The aims are: • To determine the feasibility of implementation of low and high-support exercise therapy in a transdiagnostic tertiary mental health service. • To assess the preliminary effectiveness of low and high-support exercise therapy on consumer health outcomes including physical health outcomes, health behaviours, and quality of life.
Eligibility
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Interventions
Two distinct types of supported exercise therapy will be evaluated within a transdiagnostic mental health service, low-support, and high-support exercise therapy. Both arms of this research trial consist of 12-weeks of active exercise therapy (intervention) with each arm containing different styles and components of therapy (e.g., face-to-face instructed exercise sessions, or self-directed home exercise programs). Following the 12-week supported intervention, participants in both arms will complete a 12-week maintenance period where they are encouraged to be independently active to meet Australian physical activity recommendations (Department of Health and Aged Care, 2021). Within Fremantle Hospital Mental Health Service (FHMHS) an Exercise Physiology team currently provide tailored exercise services for inpatient and community consumers as part of standard care. All community consumers referred to Exercise Physiology undertake an initial assessment covering pre-exercise risk screening, and determination of baseline characteristics (e.g., physical health, psychosocial outcomes, health behaviours, and quality of life) as part of standard care. If the consumer meets the participant inclusion criteria, they will be invited to participate in the research trial and if accepting, informed consent will be obtained, The consumer will then be allocated to either treatment arm through a pre-determined allocation method. A secondary consultation will be conducted to conclude any additional assessments required, provide health and activity recommendations, inform of the exercise intervention plan, and provide instructions for either arm of the intervention. The allocation method within this research trial is a pragmatic allocation, representing current practice within this transdiagnostic mental health hospital exercise therapy service. Allocation into either intervention arm will be determined based on participants individual circumstances and preferences, guided by clinical discretion. The allocation method used in this research trial is from a client focused perspective, in which there is communication and discussion between the participant and clinician on how best to allocate the participant to the treatment arm that is most suited to them. Trial arm 1 (low support therapy): The low support exercise intervention will include provision of a home exercise program with additional activity scheduling related to structured physical activity goals. The home exercise programs, and activity scheduling will be individually tailored by Accredited Exercise Physiologists and prescribed based on the initial assessment, participant goals, participant preferences, resources available, and physical capacity. The prescribed home-based exercise programs will be individually tailored and pragmatic in nature but will consist of strength-based major muscle group exercises including free-weight and body weight exercises, and cardiovascular exercise such as outdoor walking, outdoor cycling, or stationary exercise depending on the participants access to equipment. The goal of the home-based exercise program will be for participants to complete a minimum of 150 minutes of moderate intensity exercise per week, incorporating components of muscle strength and cardiovascular exercise as per Australian public health recommendations (Department of Health and Aged Care, 2021). To meet recommendations participants will be supplied with an individually tailored, multimodal exercise program, that will consist of a minimum 150 minutes of exercise per week, split across 5 sessions of 30 minutes duration. Three of these sessions per week will be completion of a strength-based exercise program, with the other 2 sessions being completion of 30 minutes of cardiovascular exercise. Despite the planned 2 cardiovascular exercise sessions per week, for best practice, participant centred care, the total 60 minutes of total cardiovascular exercise can be separated throughout the week into bouts of a minimum of 10 minutes in discussion with the Exercise Physiologist (e.g., 20 minutes of cardiovascular exercise 3 times per week). The programs will be individualised and progressive, so participants will be provided programs that aligns with their current activity levels and capabilities. For example, they may commence with shorter, more frequent bouts of exercise (e.g., 5 x 10 minutes of cardiovascular exercise such as outdoor walking and 3 x 10 minutes of their strength programs per week); however, this will be progressively increased to meet the 150-minute target at the conclusion of the initial 4 weeks. Participants will be instructed to record instances of exercise program completion, including time, type, repetitions or distance, and intensity (e.g., load, rating of perceived exertion) on a provided paper-based exercise program and participant tracking sheet. The planned exercise volume during this intervention arm if participants were to commence at 150 minutes per week in the initial week is 1800 minutes; however, this is unlikely for all participants. From week 5 until the end of the 12-week intervention, the participants will be aiming to complete 150 minutes of exercise per week and as such should complete a minimum of 1200 minutes in this time. There are no minimum exercise sessions planned as this will be altered per participant; however, if participants complete 3 x strength sessions and 2 x cardiovascular sessions per week there is an expected 60 instances of exercise within this intervention arm. During the 12-week intervention period, every two weeks a research team member will contact the participant via telephone, email, or SMS (depending on participant preference) to check-in, discuss their progress and challenges, and provide any increase or alterations to their exercise program. During check-in’s, exercise and activity planning is likely to be adjusted in discussion with the participant due to anticipated improvements in exercise capacity and tolerance, or to adjust for any periods of health decline. A written copy of any changes to exercise programs will be given post check in, either via SMS, email, mail, or face-to-face based on participant preference. Each week of a scheduled contact, the research team member will attempt to contact the participant a maximum of three times, if there is no response or contact from the participant after three attempts, that week will be deemed as concluded and marked as unable to contact, with the researcher to contact in the next scheduled contact week. All attempts to contact and the replies from participants will be recorded by staff on duplicates of the exercise programs and tracking sheets retained by staff, with brief text detailing the outcome of each contact. Trial arm 2 (high support therapy): As part of the Exercise Physiology department standard practice, group exercise sessions are provided for consumers at an on-site gymnasium, and an off-site community gym, with participants in the high support intervention being enrolled in these groups. Participants will attend 3 supported exercise sessions per week at either the on-site or off-site gym, with all sessions supervised by Accredited Exercise Physiologists from FHMHS or the research team. The high-support participants will be provided an individually tailored, pragmatic exercise program, supervised by Accredited Exercise Physiologists during access to an exercise facility. The exercise programs will be prescribed based on the results of initial assessment, participant goals, participant preferences, and physical capacity. In conjunction with the individualised nature and participant goals of the exercise therapy, the goal of the supported exercise program will be to increase participants weekly exercise level towards public health guidelines of a minimum of 150 minutes of moderate intensity physical activity and incorporate components of resistance and cardiovascular exercise (Department of Health and Aged Care, 2021). To meet these recommendations, the 12-week exercise intervention will consist of 3 times weekly gym attendance of 50-minutes of exercise per session, with completion of a multimodal (resistance and cardiovascular) exercise program. Participants will have the option of session attendance across five days of the working week (Monday through Friday), with suggestion for practicality for participants to attend any 3 days of their choosing. As in the low support arm, participants may commence with shorter bouts; however, this will progress so that at the conclusion of the initial 4 weeks participants are attending for 3, 50-minute sessions. The planned physical activity volume is 1800 minutes from week 1 to week 12; however, from week 5 until the end of the 12-week intervention, the participants are expected to be complete a minimum of 1200 minutes of physical activity. There will be 36 sessions in total over the course of 12 weeks in the event of 100% attendance. The programs will be individually tailored, progressive and pragmatic in nature, with participants prescribed a program considering their current activity levels, capabilities, preference, and daily presentation. The intervention will have the goal of consisting of 30 minutes of moderate intensity resistance exercise (i.e., major muscle groups including free-weight and machine equipment), and 20 minutes of moderate intensity cardiovascular exercise per session (e.g., stationary exercise cycling, ski ergometer, arm ergometer). As an additional component available in the high-support intervention, heart rate will be measured during cardiovascular exercises to examine the accuracy of the participants perceived exertion; however, this will not be able to be implemented in the low support exercise therapy. Participants will be instructed to record instances of exercise program completion, including time, type, repetitions or distance, and intensity (e.g., load, heart rate, rating of perceived exertion) with support from Exercise Physiology staff on a provided paper-based exercise program and participant tracking sheet. Participants in both intervention arms will be given physical activity recommendations to be active on most days of the week and reduce time spent sedentary in line with physical activity recommendations (Department of Health and Aged Care, 2021), in addition to their prescribed exercise programs. For both intervention arms, the specific exercise and session intensity will be ascertained using a 10-point visual analogue scale of rating of perceived exertion, with moderate intensity being defined as between 5-7 on a 10-point scale. Perceived exertion in the high support exercise intervention will be determined at the conclusion of each session with assistance from staff to monitor session intensity, while also during exercise sessions to determine specific exercise intensity and loads. In the low-support exercise intervention rating of perceived exertion will also be recorded per exercise and per session; however, will be participant recorded. Loads for all exercises will increase through progressive overload principles (Kent, 2006), with increases of load per exercise and per session as exercise capacity increases and perceived exertion decreases, to ensure participants are continually completing moderate intensity exercise. Participants will be provided education on the use of the Rating of Perceived Exertion scale at baseline. Participants in both intervention arms will be given a participant workbook that includes information, examples, and graphics on general physical activity recommendations, rating of perceived exertion, rating of breathlessness, exercise and muscle soreness, exercise and hydration, and general dietary guidelines for improving diet quality, created in line with Australian health recommendations and available research evidence. Post-intervention and at follow-up the participants will be invited to partake in semi-structured interviews to discuss their experiences, perceptions, and beliefs of the exercise intervention, with no negative consequences for participants if they decline invitation to these interviews.
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ACTRN12623001118695