Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders (DIG-EX)

Digital Follow-up of Exercise Training in Outpatients With Mental Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Mental Disorder
• Intervention / Treatment: Other: Intervention group/training group

Detailed Description

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
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Torgeir F Fredriksen Ektvedt, PhD Candidate; Phone Number: +47 93082893; Email: torgeir.fredriksen@ntnu.no
• Study Contact Backup: Name: Mona Nygård, Postdoc; Phone Number: +47 45203870; Email: mona.nygard@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • St. Olavs Hospital HF. And NTNU (Norwegian University of Science and Technology) Department of Mental Health, Faculty of Medicine and Health Sciences
    • Contact: Mona Nygård, PhD; Phone Number: +47 452 03 870; Email: mona.nygard@ntnu.no
    • Contact: Mariela LL Cabrera, PhD; Phone Number: +47 48280188; Email: mariela.lara@ntnu.no
    • Principal Investigator: Mona Nygård, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals receiving outpatient mental health treatment at the clinics of mental health at St. Olavs Hospital,.

  .-18-65 years old

• Both men and women able to carry out exercise training.
• Participants must be capable of giving informed consent and use HelsaMi.

Exclusion Criteria:

• Contraindications for exercise training and testing according to the ACSM specifications; life-threatening or terminal medical conditions; unable to carry out intervention or test procedures; pregnancy; mothers <6 months post-partum.
• Inpatients at an acute psychiatric ward or have any planned surgery that would interfere with the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This group 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.	Other: Intervention group/training group; 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).
No Intervention: Control gorup; This group will be encouraged to perform the same exercise training but without any follow-up support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak 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.	Baseline, 12 weeks, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity measurement	Physical activity level for 1-2 weeks (triaxial accelerometer, wGT3X-BT, ActiGraph LLC, USA)	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)	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	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.	Baseline, 12 weeks, 1 year
Feasibility - Drop-out/retention	Follow-up through HelsaMI. Training session diary of exercise performed from the Myworkout GO app.	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.	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	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	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.	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	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).	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	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	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.	Baseline, 12 weeks, 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body weight, measured in kilograms (kg). Height, measure in centimeters (cm). Body mass index (BMI) calculated by dividing the weight in kilograms by the square of the height in meters. Waist Circumference, Waist circumference is the measurement taken around the abdomen at the level of the belly button. It is used to assess abdominal fat.	Baseline, 12 weeks, 1 year
Blood pressure	The force of blood pushing against the walls of the arteries. It is measured using two numbers: systolic pressure (when the heart beats) and diastolic pressure (when the heart rests between beats).	Baseline, 12 weeks, 1 year
Blood Samples	Glucose: Measures the level of sugar in the blood. It is used to diagnose and monitor diabetes. Triglycerides: Measures the amount of fat in the blood. High levels can increase the risk of heart disease. HbA1C: Measures the average blood sugar levels over the past 2-3 months. It is used to diagnose and monitor diabetes. Apolipoprotein A1: The main protein component of HDL (good cholesterol). It helps in the transport of cholesterol from tissues to the liver. Apolipoprotein B: The main protein component of LDL (bad cholesterol). It is involved in the transport of cholesterol to tissues and is a marker for cardiovascular risk. Cholesterol: High-Density Lipoprotein (HDL): Known as "good" cholesterol, it helps remove bad cholesterol from the bloodstream. Low-Density Lipoprotein (LDL): Known as "bad" cholesterol, high levels can lead to plaque buildup in arteries and increase the risk of heart disease. Total Cholesterol: The sum of HDL, LDL, and other lipid components in the blood	Baseline, 12 weeks, 1 year

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Molde University College

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Peak oxygen uptake; Exercise physiology; Digital follow-up; Aerobic high-intensity interval training; Mental health disorder
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 633068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No