Severe Mental DisorderDIG-EXNCT06628011
Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders
A study testing Intervention group/training group in people with Severe Mental Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Intervention group/training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2025to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs Hospital HF. And NTNU (Norwegian University of Science and Technology) Department of Mental Health, Faculty of Medicine and Health Sciences
Trondheim
Mona Nygård, PhD, +47 452 03 870, mona.nygard@ntnu.no
Mariela LL Cabrera, PhD, +47 48280188, mariela.lara@ntnu.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Mental Disorder
- Being tested
- Intervention group/training group
- Keywords
- Peak oxygen uptake, Aerobic high-intensity interval training, Digital follow-up, Mental health disorder, Exercise physiology
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group/training groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Intervention group/training group |
| Control gorup | No intervention | This group will be encouraged to perform the same exercise training but without any follow-up support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks, 1 year
Secondary outcomes (14)
Physical activity measurement
Physical activity level for 1-2 weeks (triaxial accelerometer, wGT3X-BT, ActiGraph LLC, USA)
Measured: 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)
Measured: 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
Measured: 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.
Measured: Baseline, 12 weeks, 1 year
Feasibility - Drop-out/retention
Follow-up through HelsaMI. Training session diary of exercise performed from the Myworkout GO app.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 12 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized at a 1:1 allocation ratio into an Intervention Group or Control Group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Molde University College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628011
- Sponsor's protocol ID
- 633068
- Acronym
- DIG-EX
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Follow-up of Exercise Training in Outpatients With Mental Disorders
- ClinicalTrials.gov ID
- NCT06628011
- Acronym / sponsor ID
- DIG-EX / 633068
- Conditions
- Severe Mental Disorder
- Keywords
- Peak oxygen uptake, Aerobic high-intensity interval training, Digital follow-up, Mental health disorder, Exercise physiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Molde University College
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized at a 1:1 allocation ratio into an Intervention Group or Control Group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention group/training groupThis 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. |
| Control gorup | No intervention | –This group will be encouraged to perform the same exercise training but without any follow-up support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group/training groupWe 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). | Other | Intervention group |
Primary outcome
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.
14 secondary outcomes
Physical activity measurement
Time frame: 1-2 weeks
Use of health care services
Time frame: Baseline, 12 weeks, 1 year
Usage data of HelsaMi
Time frame: Baseline, 12 weeks, 1 year
Functional performance/capacity
Time frame: Baseline, 12 weeks, 1 year
Feasibility - Drop-out/retention
Time frame: 12 weeks, 1 year
Changes in walking economy
Time frame: Baseline, 12 weeks, 1 year
Motivation to Exercise: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
Time frame: Baseline, 12 weeks, 1 year
Health Literacy: eHealth Literacy Scale (eHEALS)
Time frame: Baseline, 12 weeks, 1 year
Mental Health-Related Barriers and Benefits to Exercise: MEX
Time frame: Baseline, 12 weeks, 1 year
Potential Barriers and Enablers Reported: System Usability Scale (SUS)
Time frame: Baseline, 12 weeks, 1 year
Patient satisfaction (questionnaires)
Time frame: Baseline, 12 weeks, 1 year
Patient activation
Time frame: Baseline, 12 weeks, 1 year
Quality of life
Time frame: Baseline, 12 weeks, 1 year
Quality-adjusted life year
Time frame: Baseline, 12 weeks, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group/training group in people with Severe Mental Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Torgeir F Fredriksen Ektvedt, PhD Candidate (+47 93082893, torgeir.fredriksen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: Baseline, 12 weeks, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.