Clinical trial NCT06659913: Project 3/7; Increased Physical Activity for Body and Mind
Official title: Project 3/7; Increased Physical Activity for Body and Mind
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Impairment
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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?

Eligibility 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.

Primary outcomes:
measure: Physical activity level
timeFrame: after 12 weeks intervention
Secondary outcomes:
measure: Psychiatric symptom pressure and quality of life
timeFrame: after 12 weeks intervention
measure: Physical activity level, Psychiatric symptom pressure and quality of life
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
Study officials:
affiliation: Dorthe Stensvold, Professor, NTNU
name: Dorthe Stensvold Stensvold
role: PRINCIPAL_INVESTIGATOR
References: