Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Both men and women able to carry out exercise training.

Participants must be capable of giving informed consent and use HelsaMi.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Intervention group/training group

    Other intervention

    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).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control gorupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 12 weeks, 1 year

Secondary outcomes

1

Physical activity measurement

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

Time frame
1-2 weeks
2

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
3

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
4

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

Other outcomes

1

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.

Time frame
Baseline, 12 weeks, 1 year
2

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).

Time frame
Baseline, 12 weeks, 1 year
3

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

Time frame
Baseline, 12 weeks, 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norwegian University of Science and Technology

Lead sponsor

St. Olavs Hospital

Collaborator

Molde University College

Collaborator