Clinical trial NCT06628011: Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders
Official title: Digital Follow-up of Exercise Training in Outpatients With Mental Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Mental Disorder
Keywords: Peak oxygen uptake
Aerobic high-intensity interval training
Digital follow-up
Mental health disorder
Exercise physiology
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Molde University College
name: NTNU Health (sponsor)
First posted: 2024-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized at a 1:1 allocation ratio into an Intervention Group or Control Group.
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: 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 \&lt;6 months post-partum.
* Inpatients at an acute psychiatric ward or have any planned surgery that would interfere with the intervention.

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: Baseline, 12 weeks, 1 year
Secondary outcomes:
measure: Physical activity measurement
timeFrame: 1-2 weeks
measure: Use of health care services
timeFrame: Baseline, 12 weeks, 1 year
measure: Usage data of HelsaMi
timeFrame: Baseline, 12 weeks, 1 year
measure: Functional performance/capacity
timeFrame: Baseline, 12 weeks, 1 year
measure: Feasibility - Drop-out/retention
timeFrame: 12 weeks, 1 year
measure: Changes in walking economy
timeFrame: Baseline, 12 weeks, 1 year
measure: Motivation to Exercise: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
timeFrame: Baseline, 12 weeks, 1 year
measure: Health Literacy: eHealth Literacy Scale (eHEALS)
timeFrame: Baseline, 12 weeks, 1 year
measure: Mental Health-Related Barriers and Benefits to Exercise: MEX
timeFrame: Baseline, 12 weeks, 1 year
measure: Potential Barriers and Enablers Reported: System Usability Scale (SUS)
timeFrame: Baseline, 12 weeks, 1 year
measure: Patient satisfaction (questionnaires)
timeFrame: Baseline, 12 weeks, 1 year
measure: Patient activation
timeFrame: Baseline, 12 weeks, 1 year
measure: Quality of life
timeFrame: Baseline, 12 weeks, 1 year
measure: Quality-adjusted life year
timeFrame: Baseline, 12 weeks, 1 year
Other outcomes:
measure: Body composition
timeFrame: Baseline, 12 weeks, 1 year
measure: Blood pressure
timeFrame: Baseline, 12 weeks, 1 year
measure: Blood Samples
timeFrame: Baseline, 12 weeks, 1 year
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF. And NTNU (Norwegian University of Science and Technology) Department of Mental Health, Faculty of Medicine and Health Sciences
Study officials:
References: