Mental Health ImpairmentProject 3/7NCT06659913
Project 3/7; Increased Physical Activity for Body and Mind
A study testing Exercise training in people with Mental Health Impairment, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Mental Health Impairment
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNorway
- Study dates
- 13 Apr 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria is low levels of physical activity, defined as not participating in any sport activity and/or drop-out of PE in school.
Who cannot join
- Exclusion criteria are patients with a serious eating disorder or other health condition where exercise is not recommended.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
Trondheim, 7006
Dorthe Stensvold, 4772828092, dorthe.stensvold@ntnu.no
About this study
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.
Read the 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:
- 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?
- 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?
- 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
- Being tested
- Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Exercise training |
| Control group | Active comparator | The control group will receive treatment as usual Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Obejctively measured total physical activity level
Measured: after 12 weeks intervention
Secondary outcomes (2)
Psychiatric symptom pressure and quality of life
Psychiatric symptom pressure and quality of life will be measured using questionaires
Measured: after 12 weeks intervention
Physical activity level, Psychiatric symptom pressure and quality of life
Same outcome as Outcome 1 and Outcome 2 post intervention
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start13 Apr 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorthe Stensvold Stensvold, Principal investigator, Dorthe Stensvold, Professor, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659913
- Sponsor's protocol ID
- 245639
- Acronym
- Project 3/7
- Status last verified
- Oct 2024
- First submitted
- 13 Mar 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 3/7; Increased Physical Activity for Body and Mind
- ClinicalTrials.gov ID
- NCT06659913
- Acronym / sponsor ID
- Project 3/7 / 245639
- Conditions
- Mental Health Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Exercise trainingThe 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. |
| Control group | Active comparator | Behavioral: Exercise trainingThe control group will receive treatment as usual |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria is low levels of physical activity, defined as not participating in any sport activity and/or drop-out of PE in school.
Key exclusion criteria (1 listed)
- Exclusion criteria are patients with a serious eating disorder or other health condition where exercise is not recommended.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingSession 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. | Behavioural | Control group, Intervention group |
Primary outcome
Physical activity level
Time frame: after 12 weeks intervention
Obejctively measured total physical activity level
2 secondary outcomes
Psychiatric symptom pressure and quality of life
Time frame: after 12 weeks intervention
Physical activity level, Psychiatric symptom pressure and quality of life
Time frame: 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Mental Health Impairment
Not yet recruiting
Thrive at Home: A Virtual Reality Social Intervention for Older Adults
Mental Health (Depression), Mental Health and General Well-being
Recruiting
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Head and Neck Cancer, Body Image Disturbance
Active, not recruiting
A Study of Healthy Microbiome, Healthy Mind
Critical Illness, COVID-19
Active, not recruiting
Pharmacogenetic Supported Prescribing in Kids
Mental Health Impairment
Active, not recruiting
Fostering Healthy Futures for Teens: An RCT
Child Abuse, Child Neglect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorthe Stensvold Stensvold principal investigator
Dorthe Stensvold, Professor, NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Mental Health Impairment, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorthe Stensvold (4792092856, dorthe.stensvold@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: after 12 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.