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

NCT06628011 | Recruiting

• 1 other identifier: 633068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mental Disorder

Keywords

Peak oxygen uptake; Aerobic high-intensity interval training; Digital follow-up; Mental health disorder; Exercise physiology

Outcome Measures

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.

  Baseline, 12 weeks, 1 year

Secondary Outcomes (14)

• Physical activity measurement

  1-2 weeks

• Use of health care services

  Baseline, 12 weeks, 1 year

• Usage data of HelsaMi

  Baseline, 12 weeks, 1 year

• Functional performance/capacity

  Baseline, 12 weeks, 1 year

• Feasibility - Drop-out/retention

  12 weeks, 1 year

Other Outcomes (3)

• Body composition

  Baseline, 12 weeks, 1 year

• Blood pressure

  Baseline, 12 weeks, 1 year

• Blood Samples

  Baseline, 12 weeks, 1 year

Study Arms (2)

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.

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

Interventions

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals receiving outpatient mental health treatment at the clinics of mental health at St. Olavs Hospital,.
• years old
• Both men and women able to carry out exercise training.
• Participants must be capable of giving informed consent and use HelsaMi.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Molde University College: collaborator
• NTNU Health (sponsor): collaborator

Study Sites (1)

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

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Torgeir F Fredriksen Ektvedt, PhD Candidate

CONTACT

+47 93082893; torgeir.fredriksen@ntnu.no

Mona Nygård, Postdoc

CONTACT

+47 45203870; mona.nygard@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are aware of which group they are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized at a 1:1 allocation ratio into an Intervention Group or Control Group.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: October 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)