This randomized-controlled trial (RCT) will investigate if digital follow-up of exercise, i.e. followup through the new citizen portal HelsaMi, coupled with an exercise app can result in exercise adherence and improved oxygen uptake in individuals with mental disorders (MD). Secondary, the project will provide information regarding effects on cardiovascular disease risk-factors, functional capacity, quality of life, satisfaction, and cost through a randomized-controlled trial (RCT) including individuals with MDs. Outcomes assessed in this project, such as maximal oxygen uptake, functional capacity, and quality of life, are strongly related to the ability to carry out activities of daily living. These outcomes are associated with benefits such as reduced sick leave, extended life expectancy, independence, and improved health status with increasing age. Economically, with the world population growing older and health care resources being stretched, there is clearly a need to apply and evaluate effective alternative methods to improve somatic health on a broader scale in a sustainable fashion, preferably utilizing existing platforms and exercise apps.
The main aim of this randomized controlled trial (RCT) is to investigate if digital exercise followup can support exercise adherence and result in increased aerobic capacity in individuals with MDs. We will assess the short-term effects through a 12-week intervention, and its long-term effects after 1-year. Both the intervention group (IG) and control group (CG) will receive two sessions of aerobic interval training at the Exercise Training Clinic, situated at the Department of Psychosis and Rehabilitation, Psychiatry Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. One training session consists of 36 minutes of high intensity training (HIT). HIT consists of 4x4 intervals on a treadmill at 85-95% of maximal heart rate, interspersed by 3minute active rest periods at 70% maximal heart rate \[31\]. Following the educational exercise sessions at the Exercise Training Clinic, the IG will be encouraged to perform two aerobic interval training sessions per week for 12 weeks, on their own and not at the exercise training clinic, while receiving digital follow-up support through HelsaMi and exercise guidance through the exercise app. The digital follow-up through HelsaMi will consist of overview of treatment progress and schedule, communication with health care personnel (video consultation or chat up to 2 times per week), notifications reminding them to exercise, exercise diary, questionnaires, and educational content. Objective. To investigate if digital exercise follow-up through HelsaMi combined with an exercise app (Myworkout GO) in individuals with MDs is more effective at improving exercise adherence and aerobic capacity compared to standard treatment coupled with advice on how to perform high intensity interval training without any digital follow-up. Main hypothesis. Digital follow-up of exercise yields better results than only being advised to exercise at improving exercise adherence, peak oxygen uptake (V̇ O2peak), work efficiency, functional capacity, and quality of life after 12 weeks and 1-year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
We will assess the short-term effects through a 12-week intervention, and its long-term effects after 1-year. Both the intervention group (IG) and control group (CG) will receive two sessions of aerobic interval training at the Exercise Training Clinic, situated at the Department of Psychosis and Rehabilitation, Psychiatry Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. One training session consists of 36 minutes of high intensity training (HIT).
St. Olavs Hospital HF. And NTNU (Norwegian University of Science and Technology) Department of Mental Health, Faculty of Medicine and Health Sciences
Trondheim, Norway
RECRUITINGPeak oxygen uptake
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline. Using the The Vyntus ONE with a mixing chamber. It is a powerful tool for comprehensive cardiopulmonary testing, providing accurate and reliable data to help clinicians make informed decisions.
Time frame: Baseline, 12 weeks, 1 year
Physical activity measurement
Physical activity level for 1-2 weeks (triaxial accelerometer, wGT3X-BT, ActiGraph LLC, USA)
Time frame: 1-2 weeks
Use of health care services
Medical record data, Norwegian patient register (NPR) and the Norwegian Registry for Primary Health Care (NRPHC) - which together cover all governmental-funded health care, and occupational status (NAV)
Time frame: Baseline, 12 weeks, 1 year
Usage data of HelsaMi
Helseplattformen: Number of times logging in, time spent in the program. Usaga data from the exercise app such as number of exercise sessions logged, and exercise intensity will be collected from Myworkout AS. Medications, diagnosis, number of hospitalizations
Time frame: Baseline, 12 weeks, 1 year
Functional performance/capacity
* Sit-to-stand test: 30-second sit-to-stand test. Number of full stands in 30 seconds. * Unipedal stance test: Single leg stance. Measured in seconds. * Stair performance: Stair test. Participants are instructed to ascend and descend 18 steps 3 consecutive times. Performance measured in seconds.
Time frame: Baseline, 12 weeks, 1 year
Feasibility - Drop-out/retention
Follow-up through HelsaMI. Training session diary of exercise performed from the Myworkout GO app.
Time frame: 12 weeks, 1 year
Changes in walking economy
Walking economy (oxygen uptake at a standard workload) after the training period subtracted walking economy at baseline. It is tested at a submaximal workload and calculated as a reduction in whole body pulmonary V̇O2 or energy expenditure (Kcal∙-min) accomplished during walking.
Time frame: Baseline, 12 weeks, 1 year
Motivation to Exercise: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
The BREQ-2 is a 19-item questionnaire that measures different types of motivation for exercise based on self-determination theory. It includes factors such as intrinsic motivation, identified regulation, introjected regulation, external regulation, and amotivation
Time frame: Baseline, 12 weeks, 1 year
Health Literacy: eHealth Literacy Scale (eHEALS)
The eHEALS is an 8-item scale designed to assess consumers' perceived skills at finding, evaluating, and applying electronic health information. It measures knowledge, comfort, and perceived skills in using eHealth resources
Time frame: Baseline, 12 weeks, 1 year
Mental Health-Related Barriers and Benefits to Exercise: MEX
The MEX scale is a 30-item measure that assesses mental health-related barriers and benefits to exercise. It includes two subscales: one for barriers and one for benefits, each with 15 items. It is designed to understand how mental health symptoms impact exercise engagement.
Time frame: Baseline, 12 weeks, 1 year
Potential Barriers and Enablers Reported: System Usability Scale (SUS)
The SUS is a 10-item Likert scale that provides a global measure of system usability. It assesses the effectiveness, efficiency, and satisfaction of a system from the user's perspective
Time frame: Baseline, 12 weeks, 1 year
Patient satisfaction (questionnaires)
Client Satisfaction Questionnaire-8 (CSQ-8): The CSQ-8 is an 8-item questionnaire designed to measure client satisfaction with health and human services. It provides a global measure of satisfaction, with items rated on a 4-point scale from "1" (low satisfaction) to "4" (high satisfaction).
Time frame: Baseline, 12 weeks, 1 year
Patient activation
Patient Activation Measure for Mental Health (PAM-13, MH): The PAM-13 is a 13-item questionnaire that assesses a patient's knowledge, skills, and confidence in managing their own health. It is specifically adapted for mental health contexts to measure the level of patient activation
Time frame: Baseline, 12 weeks, 1 year
Quality of life
Quality of life: SF-36® Health Survey (SF-36): Designed to measure overall health status and quality of life. It covers eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health
Time frame: Baseline, 12 weeks, 1 year
Quality-adjusted life year
EuroQol five dimensions questionnaire (EQ-5D-3L): A standardized instrument used to measure health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three levels of severity. It also includes a visual analogue scale (VAS) for self-rated health.
Time frame: Baseline, 12 weeks, 1 year
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