Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06628011

Digital Follow-up of Aerobic Interval 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Olavs Hospital HF. And NTNU (Norwegian University of Science and Technology) Department of Mental Health, Faculty of Medicine and Health Sciences

Trondheim, Norway

Location status: Recruiting

Location contact

Mariela LL Cabrera, PhD

CONTACT

[email protected]

+47 48280188

Mona Nygård, PhD

CONTACT

[email protected]

+47 452 03 870

Mona Nygård, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention group/training group

Other

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).

Primary outcomes

  1. Peak oxygen uptake

    Time frame: Baseline, 12 weeks, 1 year

    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.

Secondary outcomes

  1. Physical activity measurement

    Time frame: 1-2 weeks

    Physical activity level for 1-2 weeks (triaxial accelerometer, wGT3X-BT, ActiGraph LLC, USA)

  2. Use of health care services

    Time frame: Baseline, 12 weeks, 1 year

    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)

  3. Usage data of HelsaMi

    Time frame: Baseline, 12 weeks, 1 year

    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

  4. Functional performance/capacity

    Time frame: Baseline, 12 weeks, 1 year

    • 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.
  5. Feasibility - Drop-out/retention

    Time frame: 12 weeks, 1 year

    Follow-up through HelsaMI. Training session diary of exercise performed from the Myworkout GO app.

  6. Changes in walking economy

    Time frame: Baseline, 12 weeks, 1 year

    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.

  7. Motivation to Exercise: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)

    Time frame: Baseline, 12 weeks, 1 year

    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

  8. Health Literacy: eHealth Literacy Scale (eHEALS)

    Time frame: Baseline, 12 weeks, 1 year

    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

  9. Mental Health-Related Barriers and Benefits to Exercise: MEX

    Time frame: Baseline, 12 weeks, 1 year

    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.

  10. Potential Barriers and Enablers Reported: System Usability Scale (SUS)

    Time frame: Baseline, 12 weeks, 1 year

    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

  11. Patient satisfaction (questionnaires)

    Time frame: Baseline, 12 weeks, 1 year

    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).

  12. Patient activation

    Time frame: Baseline, 12 weeks, 1 year

    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

  13. Quality of life

    Time frame: Baseline, 12 weeks, 1 year

    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

  14. Quality-adjusted life year

    Time frame: Baseline, 12 weeks, 1 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.

Other outcomes

  1. Body composition

    Time frame: Baseline, 12 weeks, 1 year

    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.

  2. Blood pressure

    Time frame: Baseline, 12 weeks, 1 year

    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).

  3. Blood Samples

    Time frame: Baseline, 12 weeks, 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Nygård, Postdoc

CONTACT

[email protected]

+47 45203870

Torgeir F Fredriksen Ektvedt, PhD Candidate

CONTACT

[email protected]

+47 93082893

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Molde University College
  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: DIG-EX

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 4, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.