Project 3/7; Increased Physical Activity for Body and Mind

NCT ID: NCT06659913

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2025-06-30

Brief Summary

The association between adequate amount of physical activity and good health is well established and for children and young people, and sufficient physical activity is an important factor for normal growth and development. Contrary, physical inactivity is associated with higher symptom pressure of mental disorders. Adolescents with mental disorders report to be less active compare the general population, with potentially increased risk of health and lifestyle diseases. This project aims to provide new knowledge on the degree of physical activity, motivation for physical activity and subjective perception of health in adolescents in need of mental health care. Further, this project aim to provide possible solution on how to increase physical activity in this patient group. Thus, this project has the potential to impact future guidelines for mental health services for adolescents in need of mental health care.

Detailed Description

Children and adolescents are recommended to perform at least 60 minutes per day of moderate-to-vigorous intensity. Further the guidelines state that children and adolescents should, incorporate vigorous-intensity aerobic activities that strengthens muscle and skeleton at least three times a week. High intensity training has been reported to have a positive effect on mental health variables in adults with mental disorders. However, the literature lacks studies on how this exercise regime affect the degree of and motivation for physical activity in inactive adolescents suffering from mental disorders. There are few studies, especially Norwegians, that have been done on this field, and more research on how we can follow up on these guidelines is urgently needed. This project is divided into three research questions:

1. Is it possible to increase the motivation for and degree of physical activity by a 3-joint training intervention including 1) Supervised exercise training group, 2) School based training supported by teacher in physical education, 3) Homebased training supported by caregivers, in adolescence between 12-17 years of age with low physical activity level referred to CAP clinic?

2. Compared to treatment as usual; is it possible to reduce the psychiatric symptom pressure and increase quality of life in adolescents at CAP clinic, by a 12-week training intervention including 1) Supervised exercise training group, 2) School based training supported by teacher in physical education, 3) Homebased training supported by caregivers?

3. Are physical activity level, psychiatric symptom pressure, and quality of life changed 6 months post exercise intervention (after 12-weeks) in adolescents at CAP clinic?

Conditions

Mental Health Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The participants in the exercise group will be encouraged to follow the Norwegian Health authority's recommendation of being physically active for an average of 60 minutes a day, but they will also be offered a three-part intervention as a supplement to ordinary treatment. Supervised exercise will be offered once a week and they're encouraged to perform two additional exercise sessions per week.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

Session 1: Consist of high intensity interval training performed on spinning bikes. An exercise physiologist will supervise the participants to perform a light 10 min warm-up, followed by 4 min working periods (intervals) interspersed by 3 min active breaks. The intensity should be 85-95% of estimated peak heart rate, corresponding to approximately 16 on the Borg scale (17). There will be a maximum of 10 participants in each group, depending on how many patients who are recruited for each of the two inclusion periods.I In addition, participants are encouraged to participate in the physical education at school and encouraged to perform exercise during the weekend, either with their family or friends.

Control group

The control group will receive treatment as usual

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

Session 1: Consist of high intensity interval training performed on spinning bikes. An exercise physiologist will supervise the participants to perform a light 10 min warm-up, followed by 4 min working periods (intervals) interspersed by 3 min active breaks. The intensity should be 85-95% of estimated peak heart rate, corresponding to approximately 16 on the Borg scale (17). There will be a maximum of 10 participants in each group, depending on how many patients who are recruited for each of the two inclusion periods.I In addition, participants are encouraged to participate in the physical education at school and encouraged to perform exercise during the weekend, either with their family or friends.

Interventions

Exercise training

Session 1: Consist of high intensity interval training performed on spinning bikes. An exercise physiologist will supervise the participants to perform a light 10 min warm-up, followed by 4 min working periods (intervals) interspersed by 3 min active breaks. The intensity should be 85-95% of estimated peak heart rate, corresponding to approximately 16 on the Borg scale (17). There will be a maximum of 10 participants in each group, depending on how many patients who are recruited for each of the two inclusion periods.I In addition, participants are encouraged to participate in the physical education at school and encouraged to perform exercise during the weekend, either with their family or friends.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

Inclusion criteria is low levels of physical activity, defined as not participating in any sport activity and/or drop-out of PE in school.

Exclusion Criteria:

Exclusion criteria are patients with a serious eating disorder or other health condition where exercise is not recommended.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorthe Stensvold Stensvold

Role: PRINCIPAL_INVESTIGATOR

Dorthe Stensvold, Professor, NTNU

Locations

Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Dorthe Stensvold

Role: CONTACT

dorthe.stensvold@ntnu.no

4792092856

Facility Contacts

Dorthe Stensvold

Role: primary

dorthe.stensvold@ntnu.no

4772828092

Other Identifiers

245639

Identifier Type: -

Identifier Source: org_study_id